CClinicalTrials.gg
Status unknownNCT04332900Updated Mar 22, 2021

Proximal and Distal Therapeutic Approach in Pain and Lower Limb Kinematic in People With Patellofemoral Osteoarthritis

An interventional study of Elastic hip strap and Insole in Patellofemoral Osteoarthritis, sponsored by Universidade Federal de Sao Carlos. Status unknown. Open to participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-03-22.

Sponsored by Universidade Federal de Sao Carlos · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Mar 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
40 Years to 65 Years
Sex
All
01

Study summary

This is a crossover study that will investigate the immediate effects of a proximal therapeutic approach (SERF strap) and a distal one (foot orthoses) on knee pain intensity, global change, symptoms, ease of performance and confidence after each task and lower limb kinematics (hip adduction and internal hip rotation peak, rearfoor eversion peak) during functional taks (level-ground walking and stepping manoeuvres) in people with patellofemoral ostheoartritis

Read the detailed description

It will be enroled in this study 30 participants with patellofemoral ostheoartritis. The participants will be assessed during level walking at a self-selected speed and the stepping manoeuvre test under the three conditions that will be randomized: i) the control condition; ii) intervention proximal condition; and iii) intervention distal condition. The control condition refers to the condition in which no interventions will be administered. In both the intervention proximal condition and intervention distal condition, the respective therapeutic approach will be administered. For each functional task, three valid attempts will be collected. The primary outcome of this study is knee pain intensity and the secondary outcomes are both self-reported measures and kinematic variables measures. The self-reported measures are global change, symptoms, ease of performance and confidence, while the kinematic variables measures are hip adduction and internal hip rotation peak and rearfoor eversion peak

02

Conditions studied

  • Patellofemoral Osteoarthritis

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Keywords

  • Knee osteoarthritis
  • Patellofemoral joint
  • Gait
  • Pain
  • Quality of life
  • Physiotherapy
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's planned enrollment of 30 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Universidade Federal de Sao Carlos is the lead sponsor of 85 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Present anterior or retro patellar pain aggravated by two or more activities that overload the patellofemoral joint, such as going up and down stairs, squatting, remaining in the sitting position for long periods, getting up from the sitting position, kneeling or during physical exercise;
  • Reporting pain of at least 3 on an 11-point scale (0 for no pain and 10 for the worst possible pain) during the activities described above and on most days during the last month;
  • Have evidence of osteophyte formation in the patellofemoral joint on radiographs in the profile and axial skyline views through the Kellgren-Lawrence (K-L) grade ≥ 2, with minimal impairment in the tibiofemoral joint (KL \<2);
  • Body mass index (BMI) \<35 Kg / m². Participants with unilateral or bilateral symptoms will be included in the study.

Exclusion criteria

Exclusion Criteria:

  • Current use or in the last 12 months of foot orthoses;
  • Previous history of fracture or recurrent subluxation of the patella;
  • Arthroscopic surgery or knee infiltrations in the last 3 months;
  • Osteoarthritis known in other weight-bearing joints, including the spine;
  • History of surgery on the hip, knee, ankle and foot joints;
  • History of ankle sprain in the last 12 months;
  • Osteotomy in the lower limbs;
  • Current physical therapy in the lower limbs or in the last 6 weeks;
  • Use of a cane or other walking aid;
  • Any physical disability that is a contraindication for carrying out the evaluations and;
  • Punctuation that suggests dementia according to the Mini-Mental State Examination, taking into account the education of the participants.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • No intervention
    Control condition

    In this condition there will not be any application of therapeutic approach.

  • Experimental
    Intervention proximal condition

    The proximal therapeutic approach will be the SERF strap (S.E.R.F. strap; DonJoy Orthopedics, Inc., vista, CA).

    Device: Elastic hip strap

  • Experimental
    Intervention distal condition

    The distal therapeutic approach will be a pair of foot orthoses with semi-rigid arch support and medial elevation at the forefoot and at the rearfoot by 7° each (Propulsão Produtos Biomecânicos, Minas Gerais, Brazil).

    Device: Insole

Interventions

  • DeviceElastic hip strap

    The SERF Strap consist of a thin, elastic material that is secured to the proximal aspect of the leg, wraps in a spiral fashion around the thigh, and is anchored around the pelvis. The line of action of the SERF Strap pulls the hip into abdcution and external rotation.

    Also known as: S.E.R.F. Strap; DonJoy Orthopedics, Inc, vista, CA

  • DeviceInsole

    Foot orthoses with semi-rigid arch support and medial elevation at the forefoot and at the rearfoot by 7° each that is made from a block of ethyl vinyl acetate with a thermo-moldable polymer (shore hardness of 45 A) and is manufactured through an automated computer numeric control machine (CNC routers).

    Also known as: Propulsão Produtos Biomecânicos, Minas Gerais, Brasil

06

What researchers measure

Primary outcomes

  1. Pain intensity

    This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable

    Time frame: The Pain intensity will be assessed immediately after the first valid attempt of the level-walking task in the Control Condition

  2. Pain intensity

    This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable

    Time frame: The Pain intensity will be assessed immediately after the second valid attempt of the level-walking task in the Control Condition

  3. Pain intensity

    This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable

    Time frame: The Pain intensity will be assessed immediately after the third valid attempt of the level-walking task in the Control Condition

  4. Pain intensity

    This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable

    Time frame: The Pain intensity will be assessed immediately after the first valid attempt of the level-walking task in the Intervention Proximal Condition

  5. Pain intensity

    This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable

    Time frame: The Pain intensity will be assessed immediately after the second valid attempt of the level-walkingtask in the Intervention Proximal Condition

  6. Pain intensity

    This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable

    Time frame: The Pain intensity will be assessed immediately after the third valid attempt of the level-walking task in the Intervention Proximal Condition

  7. Pain intensity

    This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable

    Time frame: The Pain intensity will be assessed immediately after the first valid attempt of the level-walking task in the Intervention Distal Condition

  8. Pain intensity

    This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable

    Time frame: The Pain intensity will be assessed immediately after the second valid attempt of the level-walking task in the Intervention Distal Condition

  9. Pain intensity

    This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable

    Time frame: The Pain intensity will be assessed immediately after the third valid attempt of the level-walking task in the Intervention Distal Condition

  10. Pain intensity

    This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable

    Time frame: The Pain intensity will be assessed immediately after the first valid attempt of the stepping manoeuvre in the Control Condition

  11. Pain intensity

    This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable

    Time frame: The Pain intensity will be assessed immediately after the second valid attempt of the stepping manoeuvre in the Control Condition

  12. Pain intensity

    This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable

    Time frame: The Pain intensity will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Control Condition

  13. Pain intensity

    This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable

    Time frame: The Pain intensity will be assessed immediately after the first valid attempt of the stepping manoeuvre in the Intervention Proximal Condition

  14. Pain intensity

    This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable

    Time frame: The Pain intensity will be assessed immediately after the second valid attempt of the stepping manoeuvre in the Intervention Proximal Condition

  15. Pain intensity

    This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable

    Time frame: The Pain intensity will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Intervention Proximal Condition

  16. Pain intensity

    This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable

    Time frame: The Pain intensity will be assessed immediately after the first valid attempt of the stepping manoeuvre in the Intervention Distal Condition

  17. Pain intensity

    This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable

    Time frame: The Pain intensity will be assessed immediately after the second valid attempt of the stepping manoeuvre in the Intervention Distal Condition

  18. Pain intensity

    This variable will be collected using a visual analogue scale graduated in 100 millimeters, where the left end (zero) means no pain and the right end (ten) means the worst pain imaginable

    Time frame: The Pain intensity will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Intervention Distal Condition

Secondary outcomes

  1. A global rating of change change (GRC) questionnaire

    The GRC questionnaire is a 15 point self-report scale with criteria ranging from a 'very great deal worse' to a 'very great deal better.' The GRC is a valid and useful method for assessing the overall change in the quality of life of a person.

    Time frame: The GRC will be assessed immediately after the third valid attempt of the level-walking task in the Intervention Proximal Condition

  2. A global rating of change change (GRC) questionnaire

    The GRC questionnaire is a 15 point self-report scale with criteria ranging from a 'very great deal worse' to a 'very great deal better.' The GRC is a valid and useful method for assessing the overall change in the quality of life of a person.

    Time frame: The GRC will be assessed immediately after the third valid attempt of the level-walking task in the Intervention Distal Condition

  3. A global rating of change change (GRC) questionnaire

    The GRC questionnaire is a 15 point self-report scale with criteria ranging from a 'very great deal worse' to a 'very great deal better.' The GRC is a valid and useful method for assessing the overall change in the quality of life of a person.

    Time frame: The GRC will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Intervention Proximal Condition

  4. A global rating of change change (GRC) questionnaire

    The GRC questionnaire is a 15 point self-report scale with criteria ranging from a 'very great deal worse' to a 'very great deal better.' The GRC is a valid and useful method for assessing the overall change in the quality of life of a person.

    Time frame: The GRC will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Intervention Distal Condition

  5. Acceptable state of the patient's symptoms

    The participants will answered this following question: "Considering your usual level of pain and also your functional impairment to perform tasks on a day-to-day basis, if you performed this functional task (gait or step-down test) with the application of this intervention (elastic band on the hip or foot orthosis) going forward, would you consider your current state to be satisfactory? " Participants will could answered "yes" or "no".

    Time frame: The Acceptable state of the patient's symptoms will be assessed immediately after the third valid attempt of the level-walking tasks in the Intervention Proximal Condition

  6. Acceptable state of the patient's symptoms

    The participants will answered this following question: "Considering your usual level of pain and also your functional impairment to perform tasks on a day-to-day basis, if you performed this functional task (gait or step-down test) with the application of this intervention (elastic band on the hip or foot orthosis) going forward, would you consider your current state to be satisfactory? " Participants will could answered "yes" or "no".

    Time frame: The Acceptable state of the patient's symptoms will be assessed immediately after the third valid attempt of the level-walking tasks in the Intervention Distal Condition

  7. Acceptable state of the patient's symptoms

    The participants will answered this following question: "Considering your usual level of pain and also your functional impairment to perform tasks on a day-to-day basis, if you performed this functional task (gait or step-down test) with the application of this intervention (elastic band on the hip or foot orthosis) going forward, would you consider your current state to be satisfactory? " Participants will could answered "yes" or "no".

    Time frame: The Acceptable state of the patient's symptoms will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Intervention Proximal Condition

  8. Acceptable state of the patient's symptoms

    The participants will answered this following question: "Considering your usual level of pain and also your functional impairment to perform tasks on a day-to-day basis, if you performed this functional task (gait or step-down test) with the application of this intervention (elastic band on the hip or foot orthosis) going forward, would you consider your current state to be satisfactory? " Participants will could answered "yes" or "no".

    Time frame: The Acceptable state of the patient's symptoms will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Intervention Distal Condition

  9. Ease of performing a task

    Participants will answer the following question: "How easy was this task?" and then they will respond according to the scale (markedly difficult; somewhat difficult; neither difficult nor easy; somewhat easy; markedly easy)

    Time frame: The Ease of performing a task will be assessed immediately after the third valid attempt of the level-walking task in the Control Condition

  10. Ease of performing a task

    Participants will answer the following question: "How easy was this task?" and then they will respond according to the scale (markedly difficult; somewhat difficult; neither difficult nor easy; somewhat easy; markedly easy)

    Time frame: The Ease of performing a task will be assessed immediately after the third valid attempt of the level-walking task in the Intervention Proximal Condition

  11. Ease of performing a task

    Participants will answer the following question: "How easy was this task?" and then they will respond according to the scale (markedly difficult; somewhat difficult; neither difficult nor easy; somewhat easy; markedly easy)

    Time frame: The Ease of performing a task will be assessed immediately after the third valid attempt of the level-walking task in the Intervention Distal Condition

  12. Ease of performing a task

    Participants will answer the following question: "How easy was this task?" and then they will respond according to the scale (markedly difficult; somewhat difficult; neither difficult nor easy; somewhat easy; markedly easy)

    Time frame: The Ease of performing a task will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Control Condition

  13. Ease of performing a task

    Participants will answer the following question: "How easy was this task?" and then they will respond according to the scale (markedly difficult; somewhat difficult; neither difficult nor easy; somewhat easy; markedly easy)

    Time frame: The Ease of performing a task will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Intervention Proximal Condition

  14. Ease of performing a task

    Participants will answer the following question: "How easy was this task?" and then they will respond according to the scale (markedly difficult; somewhat difficult; neither difficult nor easy; somewhat easy; markedly easy)

    Time frame: The Ease of performing a task will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Intervention Distal Condition

  15. Knee confidence

    The knee confidence using a 100mm VAS, with the question phrased as "how confident did you feel completing that task? (terminal descriptors 0mm=very confident, 100mm=not confidente at all).

    Time frame: The knee confidence will be assessed immediately after the third valid attempt of the level-walking task in the Control Condition

  16. Knee confidence

    The knee confidence using a 100mm VAS, with the question phrased as "how confident did you feel completing that task? (terminal descriptors 0mm=very confident, 100mm=not confidente at all).

    Time frame: The knee confidence will be assessed immediately after the third valid attempt of the level-walking task in the Intervention Proximal Condition

  17. Knee confidence

    The knee confidence using a 100mm VAS, with the question phrased as "how confident did you feel completing that task? (terminal descriptors 0mm=very confident, 100mm=not confidente at all).

    Time frame: The knee confidence will be assessed immediately after the third valid attempt of the level-walking task in the Intervention Distal Condition

  18. Knee confidence

    The knee confidence using a 100mm VAS, with the question phrased as "how confident did you feel completing that task? (terminal descriptors 0mm=very confident, 100mm=not confidente at all).

    Time frame: The knee confidence will assessed immediately after the third valid attempt of the stepping manoeuvre in the Control Condition

  19. Knee confidence

    The knee confidence using a 100mm VAS, with the question phrased as "how confident did you feel completing that task? (terminal descriptors 0mm=very confident, 100mm=not confidente at all).

    Time frame: The knee confidence will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Intervention Proximal Condition

  20. Knee confidence

    The knee confidence using a 100mm VAS, with the question phrased as "how confident did you feel completing that task? (terminal descriptors 0mm=very confident, 100mm=not confidente at all).

    Time frame: The knee confidence will be assessed immediately after the third valid attempt of the stepping manoeuvre in the Intervention Distal Condition

  21. Lower limb kinematics - Peak of Hip Adduction

    For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.

    Time frame: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the stance phase of the level-walking of the first valid attempt in the Control Condition

  22. Lower limb kinematics - Peak of Hip Adduction

    For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.

    Time frame: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the stance phase of the gait of the second valid attempt in the Control Condition

  23. Lower limb kinematics - Peak of Hip Adduction

    For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.

    Time frame: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the stance phase of the level-walking of the third valid attempt in the Control Condition

  24. Lower limb kinematics - Peak of Hip Adduction

    For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.

    Time frame: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the stance phase of the level-walking of the first valid attempt in the Intervention Proximal Condition

  25. Lower limb kinematics - Peak of Hip Adduction

    For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.

    Time frame: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the stance phase of the level-walking of the second valid attempt in the Intervention Proximal Condition

  26. Lower limb kinematics - Peak of Hip Adduction

    For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.

    Time frame: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the stance phase of the level-walking of the third valid attempt in the Intervention Proximal Condition

  27. Lower limb kinematics - Peak of Hip Adduction

    For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.

    Time frame: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the stance phase of the level-walking of the first valid attempt in the Intervention Distal Condition

  28. Lower limb kinematics - Peak of Hip Adduction

    For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.

    Time frame: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the stance phase of the level-walking of the second valid attempt in the Intervention Distal Condition

  29. Lower limb kinematics - Peak of Hip Adduction

    For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.

    Time frame: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the stance phase of the level-walking of the third valid attempt in the Intervention Distal Condition

  30. Lower limb kinematics - Peak of Hip Medial Rotation

    For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.

    Time frame: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the stance phase of the level-walking of the first valid attempt in the Control Condition

  31. Lower limb kinematics - Peak of Hip Medial Rotation

    For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.

    Time frame: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the stance phase of the level-walking of the second valid attempt in the Control Condition

  32. Lower limb kinematics - Peak of Hip Medial Rotation

    For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.

    Time frame: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the stance phase of the level-walking of the third valid attempt in the Control Condition

  33. Lower limb kinematics - Peak of Hip Medial Rotation

    For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.

    Time frame: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the stance phase of the level-walking of the first valid attempt in the Intervention Proximal Condition

  34. Lower limb kinematics - Peak of Hip Medial Rotation

    For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.

    Time frame: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the stance phase of the level-walking of the second valid attempt in the Intervention Proximal Condition

  35. Lower limb kinematics - Peak of Hip Medial Rotation

    For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.

    Time frame: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the stance phase of the level-walking of the third valid attempt in the Intervention Proximal Condition

  36. Lower limb kinematics - Peak of Hip Medial Rotation

    For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.

    Time frame: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the stance phase of the level-walking of the first valid attempt in the Intervention Distal Condition

  37. Lower limb kinematics - Peak of Hip Medial Rotation

    For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.

    Time frame: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the stance phase of the level-walking of the second valid attempt in the Intervention Distal Condition

  38. Lower limb kinematics - Peak of Hip Medial Rotation

    For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.

    Time frame: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the stance phase of the level-walking of the third valid attempt in the Intervention Distal Condition

  39. Lower limb kinematics - Peak of Rearfoot Eversion

    For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.

    Time frame: The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the stance phase of the level-walking of the first valid attempt in the Control Condition

  40. Lower limb kinematics - Peak of Rearfoot Eversion

    For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.

    Time frame: The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the stance phase of the level-walking of the second valid attempt in the Control Condition

  41. Lower limb kinematics - Peak of Rearfoot Eversion

    For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.

    Time frame: The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the stance phase of the level-walking of the third valid attempt in the Control Condition

  42. Lower limb kinematics - Peak of Rearfoot Eversion

    For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.

    Time frame: The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the stance phase of the level-walking of the first valid attempt in the Intervention Proximal Condition

  43. Lower limb kinematics - Peak of Rearfoot Eversion

    For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.

    Time frame: The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the stance phase of the level-walking of the second valid attempt in the Intervention Proximal Condition

  44. Lower limb kinematics - Peak of Rearfoot Eversion

    For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.

    Time frame: The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the stance phase of the level-walking of the third valid attempt in the Intervention Proximal Condition

  45. Lower limb kinematics - Peak of Rearfoot Eversion

    For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.

    Time frame: The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the stance phase of the level-walking of the first valid attempt in the Intervention Distal Condition

  46. Lower limb kinematics - Peak of Rearfoot Eversion

    For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.

    Time frame: The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the stance phase of the level-walking of the second valid attempt in the Intervention Distal Condition

  47. Lower limb kinematics - Peak of Rearfoot Eversion

    For the capture and analysis of kinematic data during the execution of the level-walking, the Vicon movement capture and analysis system will be used.

    Time frame: The Lower limb kinematics - Peak of Rearfoot of Eversion will be assessed during the stance phase of the level-walking of the third valid attempt in the Intervention Distal Condition

  48. Lower limb kinematics - Peak of Hip Adduction

    For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.

    Time frame: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the first valid attempt of the stepping manoeuvre in the Control Condition

  49. Lower limb kinematics - Peak of Hip Adduction

    For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.

    Time frame: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the second valid attempt of the stepping manoeuvre in the Control Condition

  50. Lower limb kinematics - Peak of Hip Adduction

    For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.

    Time frame: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the third valid attempt of the stepping manoeuvre in the Control Condition

  51. Lower limb kinematics - Peak of Hip Adduction

    For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.

    Time frame: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the first valid attempt of the stepping manoeuvre in the Intervention Proximal Condition

  52. Lower limb kinematics - Peak of Hip Adduction

    For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.

    Time frame: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the second valid attempt of the stepping manoeuvre in the Intervention Proximal Condition

  53. Lower limb kinematics - Peak of Hip Adduction

    For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.

    Time frame: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the third valid attempt of the stepping manoeuvre in the Intervention Proximal Condition

  54. Lower limb kinematics - Peak of Hip Adduction

    For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.

    Time frame: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the first valid attempt of the stepping manoeuvre in the Intervention Distal Condition

  55. Lower limb kinematics - Peak of Hip Adduction

    For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.

    Time frame: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the second valid attempt of the stepping manoeuvre in the Intervention Distal Condition

  56. Lower limb kinematics - Peak of Hip Adduction

    For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.

    Time frame: The Lower limb kinematics - Peak of Hip Adduction will be assessed during the third valid attempt of the stepping manoeuvre in the Intervention Distal Condition

  57. Lower limb kinematics - Peak of Hip Medial Rotation

    For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.

    Time frame: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the first valid attempt of the stepping manoeuvre in the Control Condition

  58. Lower limb kinematics - Peak of Hip Medial Rotation

    For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.

    Time frame: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the second valid attempt of the stepping manoeuvre in the Control Condition

  59. Lower limb kinematics - Peak of Hip Medial Rotation

    For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.

    Time frame: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the third valid attempt of the stepping manoeuvre in the Control Condition

  60. Lower limb kinematics - Peak of Hip Medial Rotation

    For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.

    Time frame: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the first valid attempt of the stepping manoeuvre in the Intervention Proximal Condition

  61. Lower limb kinematics - Peak of Hip Medial Rotation

    For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.

    Time frame: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the second valid attempt of the stepping manoeuvre in the Intervention Proximal Condition

  62. Lower limb kinematics - Peak of Hip Medial Rotation

    For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.

    Time frame: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the third valid attempt of the stepping manoeuvre in the Intervention Proximal Condition

  63. Lower limb kinematics - Peak of Hip Medial Rotation

    For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.

    Time frame: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the first valid attempt of the stepping manoeuvre in the Intervention Distal Condition

  64. Lower limb kinematics - Peak of Hip Medial Rotation

    For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.

    Time frame: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the second valid attempt of the stepping manoeuvre in the Intervention Distal Condition

  65. Lower limb kinematics - Peak of Hip Medial Rotation

    For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.

    Time frame: The Lower limb kinematics - Peak of Hip Medial Rotation will be assessed during the third valid attempt of the stepping manoeuvre in the Intervention Distal Condition

  66. Lower limb kinematics - Peak of Rearfoot Eversion

    For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.

    Time frame: The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the first valid attempt of the stepping manoeuvre in the Control Condition

  67. Lower limb kinematics - Peak of Rearfoot Eversion

    For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.

    Time frame: The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the second valid attempt of the stepping manoeuvre in the Control Condition

  68. Lower limb kinematics - Peak of Rearfoot Eversion

    For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.

    Time frame: The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the third valid attempt of the stepping manoeuvre in the Control Condition

  69. Lower limb kinematics - Peak of Rearfoot Eversion

    For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.

    Time frame: The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the first valid attempt of the stepping manoeuvre in the Intervention Proximal Condition

  70. Lower limb kinematics - Peak of Rearfoot Eversion

    For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.

    Time frame: The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the second valid attempt of the stepping manoeuvre in the Intervention Proximal Condition

  71. Lower limb kinematics - Peak of Rearfoot Eversion

    For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.

    Time frame: The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the third valid attempt of the stepping manoeuvre in the Intervention Proximal Condition

  72. Lower limb kinematics - Peak of Rearfoot Eversion

    For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.

    Time frame: The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the first valid attempt of the stepping manoeuvre in the Intervention Distal Condition

  73. Lower limb kinematics - Peak of Rearfoot Eversion

    For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.

    Time frame: The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the second valid attempt of the stepping manoeuvre in the Intervention Distal Condition

  74. Lower limb kinematics - Peak of Rearfoot Eversion

    For the capture and analysis of kinematic data during the execution of the stepping manoeuvre, the Vicon movement capture and analysis system will be used.

    Time frame: The Lower limb kinematics - Peak of Rearfoot Eversion will be assessed during the third valid attempt of the stepping manoeuvre in the Intervention Distal Condition

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Souto LR, Serrao PRMDS, Pisani GK, Tessarin BM, da Silva HF, Machado EM, de Oliveira Sato T, Serrao FV. Immediate effects of hip strap and foot orthoses on self-reported measures and lower limb kinematics during functional tasks in individuals with patellofemoral osteoarthritis: protocol for a randomised crossover clinical trial. Trials. 2022 Sep 5;23(1):746. doi: 10.1186/s13063-022-06676-0. PubMed 36064729 ↗

Individual participant data

Plan to share: No — There is no plan to make individual participant data available to other researchers

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04332900
Lead sponsor
Universidade Federal de Sao Carlos
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Responsible party
Larissa Rodrigues Souto (Principal Investigator, Universidade Federal de Sao Carlos) — Principal investigator
First posted
Apr 3, 2020
Start date
Nov 1, 2021 (estimated)
Primary completion
May 1, 2022 (estimated)
Completion
Nov 1, 2022 (estimated)
Last update
Mar 22, 2021

Study contacts

Larissa R Souto, MSc
Contact
larissasouto@live.com
+55(18)988052128

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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