CClinicalTrials.gg
CompletedNCT06460662Updated Oct 15, 2024

Effects of Agility and Perturbation Based Training in Addition to Routine Physical Therapy

An interventional study of Routine Physical Therapy in Knee Osteoarthritis, sponsored by Riphah International University. Completed at 1 site in Pakistan. Open to participants aged 50 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-10-15.

Sponsored by Riphah International University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
50 Years to 60 Years
Sex
All
01

Study summary

Osteoarthritis is a degenerative joint disease. Knee OA patients sometimes report episodes of knee instability that limit their ADLs. The episodes of instability are similar to those reported in knee ligament injuries. It is believed that modifications of interventions that are used to promote knee stability in knee ligament injuries can be used in knee OA to enhance knee stability and function. The purpose of this study will be to determine the effects of agility and perturbation-based training in addition to routine physical therapy on pain, function, quality of life and disability in knee osteoarthritis.

Read the detailed description

A Randomized Clinical Trial will be conducted at Al Syed Touqeer Altaf Surgical Hospital through a convenience sampling technique on 26 patients, which will be allocated using computer-generated randomization into two groups. Group A will be treated with agility and perturbation training techniques in addition to the same routine physical therapy as Group B, and Group B will receive only routine physical therapy. Outcome measures will be conducted through NPRS, WOMAC, SF-36, and KOS-ADLs questionnaires. All the outcome measures will be assessed pre and post-treatment, and the assessor will be blind. Frequency of the treatment will be 3 sessions per week for 4 weeks. Data will be analyzed using SPSS software version 25.

02

Conditions studied

  • Knee Osteoarthritis

Keywords

  • pain
  • function
  • quality of life
03

In context

Osteoarthritis

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

This study's enrollment of 26 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Riphah International University is the lead sponsor of 2,133 studies on the registry; 633 are open to participants now.

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

04

Who can participate

Ages eligible
50 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Both male and female.
  • Subjects with Kellgren and Lawrence grade II and III osteoarthritis.
  • OA diagnosed subjects according to American College of Rheumatology ACR criteria;

    • Morning stiffness ≤ 30 minutes.
    • Crepitus with active motion of the knee (while weight bearing).
    • Tenderness to palpation of the bony margins of the joint, bony enlargement, and no palpable warmth.

Exclusion criteria

Exclusion Criteria:

  • Ligament or meniscal injury around the knee.
  • Suffering from acute synovitis
  • Neuromuscular disorders.
  • Cognitive impairments.
  • Required use of an assistive device for ambulation.
  • Reported a history of 2 or more falls within the previous year.
  • Undergone total knee arthroplasty.
  • Uncontrolled hypertension, history of cardiovascular disease, neurological disorders that affected lower extremity function.
  • Severe visual problems.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
26 participants (actual)

Study arms

  • Experimental
    Agility and perturbation training group

    Group A will receive agility and perturbation training techniques in addition to the same routine physical therapy as Group B. The Agility training exercises include: * Side Stepping * Braiding Activities * Front and Back Crossover Steps During Forward Ambulation * Multiple Changes in Direction During Walking on Therapist Command The perturbation training exercises include: * Double-Leg Foam Balance Activity * Tilt board Balance Training * Rollerboard and Platform Perturbations

    Other: Routine Physical Therapy

  • Active comparator
    Routine physical therapy

    Group B: Routine physical therapy Group that includes: * Calf Stretching * Hamstring Stretching * Prone Quadriceps Stretching * Long-Sitting Knee Flexion and Extension * Quadriceps setting * Supine Straight Leg Raises * Prone Hip Extensions * Standing Hamstring Curls With Cuff Weights * Standing Calf Raises * Treadmill Walking * Mobilization techniques

    Other: Routine Physical Therapy

Interventions

  • OtherRoutine Physical Therapy

    Group B: Routine physical therapy Group that includes: * Calf Stretching * Hamstring Stretching * Prone Quadriceps Stretching * Long-Sitting Knee Flexion and Extension * Quadriceps setting * Supine Straight Leg Raises * Prone Hip Extensions * Standing Hamstring Curls With Cuff Weights * Standing Calf Raises * Treadmill Walking * Mobilization techniques

06

What researchers measure

Primary outcomes

  1. Numeric pain rate scale (NPRS)

    Numeric pain rate scale will be used to quantify patient level of pain. The Numeric Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The common format is a horizontal bar or line. Although various iterations exist, the most commonly used is the 11-item NPRS. The 11-point numeric scale ranges from (no pain at all) to 10 (worst imaginable pain) i.e. higher scores indicating greater pain intensity. High test-retest reliability has been observed in both literate and illiterate patients with rheumatoid arthritis (r = 0.96 and 0.95, respectively) before and after medical consultation. For construct validity, the NPRS was shown to be highly correlated with the VAS in patients with rheumatic and other chronic pain conditions (pain\>6 months): correlations range from 0.86 to 0.95.

    Time frame: upto 4 weeks

  2. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Patients' knee function and stiffness will be measured through the Western Ontario and McMaster Universities Arthritis Index (WOMAC) . It is a self-administered questionnaire consisting of 24 items divided into 3 subscales; Pain-5 items, Stiffness-2 items, Physical Function-17 items . WOMAC Index was developed in 1982 at Western Ontario and McMaster Universities. WOMAC is available in over 65 languages and has been linguistically validated. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually, a sum of the scores for all three subscales gives a total WOMAC score.

    Time frame: upto 4 weeks

  3. SF-36 (Short form)

    36-Item Short Form Survey (SF-36) will be used to assess the quality of life. (SF-36) is an outcome measure instrument that is often used, a well-researched, self-reported measure of health. It stems from a study called the Medical Outcomes Study, which is an objective measure of quality of life. It comprises 36 questions that cover eight domains of health. The 36 questions on the SF-36 are meant to reflect 8 domains of health, including physical functioning, physical role, pain, general health, vitality, social function, emotional role, and mental health.Possible scores range from 0 to 100, with higher scores representing better health status.

    Time frame: upto 4 weeks

  4. Knee Outcome Survey Activities of Daily Living KOS-ADLS

    Knee outcome survey ADLS will be used to measure disability. The ADLS is a 14 item scale that queries patients about how their knee symptoms effect their ability to perform general daily activities (6 items) as well as how their knee condition effects their ability to perform specific functional tasks (8 items). Each item is scored 0-5 with 5 indicating "no difficulty" and 0 representing "unable to perform". The highest possible score is 70. The scores of all items are summed, divided by 70, and then multiplied by 100 to give an overall ADLS percent rating. Higher percentages reflect higher levels of functional ability. The ADLS demonstrated high test-retest reliability in 52 subjects with knee pathology. The ICC score for test-retest reliability over a 24 hour period was .97. Construct validity was determined through correlations with the Lysholm Knee Scale (r = .78 to .86).

    Time frame: upto 4 weeks

07

Study locations

1 site
  • Sher Shah Road, Shadbagh
    Lahore, Punjab 54000, Pakistan
08

References and documents

Publications

  • Lange AK, Vanwanseele B, Fiatarone Singh MA. Strength training for treatment of osteoarthritis of the knee: a systematic review. Arthritis Rheum. 2008 Oct 15;59(10):1488-94. doi: 10.1002/art.24118. PubMed 18821647 ↗
  • Hicks-Little CA, Peindl RD, Hubbard-Turner TJ, Cordova ML. The Relationship Between Early-Stage Knee Osteoarthritis and Lower-Extremity Alignment, Joint Laxity, and Subjective Scores of Pain, Stiffness, and Function. J Sport Rehabil. 2016 Aug;25(3):213-8. doi: 10.1123/jsr.2014-0170. Epub 2016 Jul 21. PubMed 27445119 ↗
  • Michael JW, Schluter-Brust KU, Eysel P. The epidemiology, etiology, diagnosis, and treatment of osteoarthritis of the knee. Dtsch Arztebl Int. 2010 Mar;107(9):152-62. doi: 10.3238/arztebl.2010.0152. Epub 2010 Mar 5. Erratum In: Dtsch Arztebl Int. 2010 Apr;107(16):294. PubMed 20305774 ↗
  • Samson DJ, Grant MD, Ratko TA, Bonnell CJ, Ziegler KM, Aronson N. Treatment of primary and secondary osteoarthritis of the knee. Evid Rep Technol Assess (Full Rep). 2007 Sep;(157):1-157. PubMed 18088162 ↗
  • Collins NJ, Hart HF, Mills KAG. Osteoarthritis year in review 2018: rehabilitation and outcomes. Osteoarthritis Cartilage. 2019 Mar;27(3):378-391. doi: 10.1016/j.joca.2018.11.010. Epub 2018 Dec 7. PubMed 30529739 ↗
  • Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. OARSI recommendations for the management of hip and knee osteoarthritis, part I: critical appraisal of existing treatment guidelines and systematic review of current research evidence. Osteoarthritis Cartilage. 2007 Sep;15(9):981-1000. doi: 10.1016/j.joca.2007.06.014. Epub 2007 Aug 27. PubMed 17719803 ↗
  • Jamtvedt G, Dahm KT, Christie A, Moe RH, Haavardsholm E, Holm I, Hagen KB. Physical therapy interventions for patients with osteoarthritis of the knee: an overview of systematic reviews. Phys Ther. 2008 Jan;88(1):123-36. doi: 10.2522/ptj.20070043. Epub 2007 Nov 6. PubMed 17986496 ↗
  • Zhang W, Moskowitz RW, Nuki G, Abramson S, Altman RD, Arden N, Bierma-Zeinstra S, Brandt KD, Croft P, Doherty M, Dougados M, Hochberg M, Hunter DJ, Kwoh K, Lohmander LS, Tugwell P. OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage. 2008 Feb;16(2):137-62. doi: 10.1016/j.joca.2007.12.013. PubMed 18279766 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06460662
Lead sponsor
Riphah International University
Responsible party
Sponsor
First posted
Jun 14, 2024
Start date
Jun 30, 2024
Primary completion
Sep 30, 2024
Completion
Oct 10, 2024
Last update
Oct 15, 2024

Study contacts

Maryam Ijaz, MSPT*
principal investigator · Riphah International University,Lahore

Oversight

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

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