CClinicalTrials.gg
CompletedNCT06351189DYNAMIC SYSTEMUpdated Dec 5, 2025

NETTI Wheelchair: Does Dynamic Mode or Static Mode Affect the Sitting Position in Patients With Involuntary Movements ?

An observational study in Hyperextension Spasms and Involuntary Movements, sponsored by Centre Hospitalier Universitaire de Nīmes. Completed at 1 site in France. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2025-12-05.

Sponsored by Centre Hospitalier Universitaire de Nīmes · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
4
Ages
16 Years and older
Sex
All
01

Study summary

This study compares two modes of the NETTI wheelchair (dynamic or sitting) for patients with hyperkinetic syndromes, to discover which mode is the most comfortable and best suited to these patients.

It is a prospective, single-center pilot study comparing two medical devices evaluated using SCED (Single Case Experimental Design) ABAB methodology: NETTI DYNAMIC chair in dynamic mode (intervention group; phase B) versus the same chair in static mode (control group; phase A). The subject will be his/her own control

Read the detailed description

Hyperkinetic syndromes are characterized by excessive or involuntary movements throughout the day. These abnormal movements interfere with maintaining the ideal sitting position and cause positioning disorders that may have functional repercussions. To facilitate staying in the ideal position, therapists adapt sitting positions. Together with the patient, they choose the position that appears to be the most functional and comfortable. To maintain this position, the solutions proposed are mainly based on restraint (shells, abduction blocks, straps, etc.). These can be poorly tolerated by the patient, causing discomfort or even pain which can hinder participation. Repeated stresses on the supports, and on the chair itself, leads to frequent breakage. Also, depending on the underlying neurological mechanisms behind the abnormal movements, the question arises as to whether restraint increases the frequency or amplitude of abnormal movements by generating oppositional constraints, areas of discomfort and/or pain, or by reducing functional capacities and frustration caused by these abnormal movements (Cimolin et al. 2009). All these issues can have a significant impact on the quality of life of this population of patients suffering from abnormal movements and who are almost exclusively in wheelchairs. To address these issues, dynamic wheelchair systems have been have been developed to absorb the mechanical stresses generated by abnormal movements.

The chair's dynamic components absorb the force. When the patient's force ceases, the stored energy is returned by the dynamic component which, in turn, helps the patient return to his or her starting position. The ideal seating system enables controlled movement whilst providing mechanical stability.

This is a prospective, single-center pilot study comparing the two medical device modes using an ABAB-type Single Case Experimental Design methodology: The NETTI DYNAMIC chair in dynamic mode (interventional group; phase B) versus the same chair in static mode (control group; phase A). The subject will be his/her own control.

Phase B (intervention) will be performed by positioning the subject on the Netti Dynamic chair in its dynamic configuration. Phase A (control), on the other hand, will be performed positioned on the same chair, but in static mode (backrest and seat locked by means of a jack and pin, legrest and headrest replaced by standard elements and headrest replaced by standard components, making it impossible to adapt the chair's of the chair). In this way, the specific effect of the dynamic mode will be able to be controlled.

The ABAB study design was chosen for this study because it provides the highest level of evidence evidence (Level 1; OCEBM Levels of Evidence Working Group. (2011). "The Oxford 2011 Levels of Evidence." Oxford Centre for Evidence-Based Medicine). It is characterized by the presence of two phases (phase A: control phase and phase B: intervention phase) which are alternated twice.

Each phase must comprise three to five measures to enable reliable statistical analysis. This approach is particularly appropriate for evaluating medical devices, especially when the when the population concerned is heterogeneous. Indeed, an intensive, prospective study of a few individuals, using a methodology defined a priori, including systematic observations, repeated measurements and appropriate data analysis is the most appropriate in this case.

02

Conditions studied

  • Hyperextension Spasms
  • Involuntary Movements

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Keywords

  • Wheelchair
  • Single-case experimental design
  • Hyperextension spasms
  • Positioning
03

In context

Dyskinesias

270 studies on the registry are indexed under Dyskinesias; 41 are open to participants now.

This study's enrollment of 4 is below the median of 70 across 70 observational studies indexed under Dyskinesias.

Browse Dyskinesias studies →

Lead sponsor

Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 587 studies on the registry; 96 are open to participants now.

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

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

The study population is made up of patients with involuntary extension movements at a frequency of more than 3/hour, requiring at least one wheelchair repositioning every 2 hours, cared for in a medico-educational institute, a specialized residence such as a Specialised Care Home or a Medicalized Care Home, or living at home if necessary.

Inclusion criteria

  • Patient with involuntary extension movements with a frequency greater than (>) 3/hour and requiring at least one wheelchair repositioning every 2 hours.
  • Patient using a wheelchair and requiring to be in a seated position at least 4 hours per day.
  • Patient and/or representative with free and informed consent.
  • Patient and/or representative having signed the consent form.
  • Patient affiliated or beneficiary of a health insurance plan.
  • Patient over 16 years of age (≥16 years).

Exclusion criteria

Exclusion Criteria:

  • Patient unable to sit in chair for at least 3 hours a day.
  • Patient unable to sit in the chair without the use of a thermoformed corset.
  • Patients weighing over 135kg.
  • Patient participating in a drug study.
  • Patient in an exclusion period determined by another study.
  • Patient/legal representative for whom it is impossible to provide informed information.
  • Pregnant or breast-feeding patient
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
4 participants (actual)
Patient registry
No

Groups and cohorts

  • Control group: STATIC MODE

    The patient will be positioned on the Netti Dynamic chair in static mode.

    Device: Observation

  • Interventional group: DYNAMIC MODE

    The patient will be positioned on the Netti Dynamic chair in dynamic mode.

    Device: Observation

Interventions

  • DeviceObservation

    Patients will be filmed in sitting position in the NETTI DYNAMIC chair, either in static mode or dynamic mode for a period of 3 hours each time.

06

What researchers measure

Primary outcomes

  1. Forward slippage in static mode (PHASE A)

    Measurement of forward slippage (mm) of the pelvis in relation to the backrest of the chair. This assessment will be made after each involuntary movement over the 3-hour observation period.Collection tools/methods : Go pro positioning: see face + torso Sensor positioning: 4 motion sensors record continuously throughout the sequence: one on the back of the chair, one on the thorax over the sternum, one on the anterior superior iliac spine and one on the top of the homolateral thigh. Motion sensor data are sent by e-mail ( .csv file), together with a timeline (word file) of the occurrence of abnormal movements. They are sent pseudonymized simultaneously to Mike Dongelmans (ALU REHAB AS, Norway) and MotionCatch / Denmark (which carries out the analysis on behalf of ALU REHAB AS). In order to mark the "involuntary movement" events on the video, the collaborator will have to be able to identify which chair it is, but then, for the forward-slippage data analysis, this will be done under

    Time frame: End of the 3-hour period on Day 7

  2. Forward slippage in static mode (PHASE A)

    Measurement of forward slippage (mm) of the pelvis in relation to the backrest of the chair. This assessment will be made after each involuntary movement over the 3-hour observation period.Collection tools/methods : Go pro positioning: see face + torso Sensor positioning: 4 motion sensors record continuously throughout the sequence: one on the back of the chair, one on the thorax over the sternum, one on the anterior superior iliac spine and one on the top of the homolateral thigh. Motion sensor data are sent by e-mail ( .csv file), together with a timeline (word file) of the occurrence of abnormal movements. They are sent pseudonymized simultaneously to Mike Dongelmans (ALU REHAB AS, Norway) and MotionCatch / Denmark (which carries out the analysis on behalf of ALU REHAB AS). In order to mark the "involuntary movement" events on the video, the collaborator will have to be able to identify which chair it is, but then, for the forward-slippage data analysis, this will be done under

    Time frame: End of the 3-hour period on Day 14

  3. Forward slippage in static mode (PHASE A)

    Measurement of forward slippage (mm) of the pelvis in relation to the backrest of the chair. This assessment will be made after each involuntary movement over the 3-hour observation period.Collection tools/methods : Go pro positioning: see face + torso Sensor positioning: 4 motion sensors record continuously throughout the sequence: one on the back of the chair, one on the thorax over the sternum, one on the anterior superior iliac spine and one on the top of the homolateral thigh. Motion sensor data are sent by e-mail ( .csv file), together with a timeline (word file) of the occurrence of abnormal movements. They are sent pseudonymized simultaneously to Mike Dongelmans (ALU REHAB AS, Norway) and MotionCatch / Denmark (which carries out the analysis on behalf of ALU REHAB AS). In order to mark the "involuntary movement" events on the video, the collaborator will have to be able to identify which chair it is, but then, for the forward-slippage data analysis, this will be done under

    Time frame: End of the 3-hour period on Day 21

  4. Forward slippage in static mode (PHASE A)

    Measurement of forward slippage (mm) of the pelvis in relation to the backrest of the chair. This assessment will be made after each involuntary movement over the 3-hour observation period.Collection tools/methods : Go pro positioning: see face + torso Sensor positioning: 4 motion sensors record continuously throughout the sequence: one on the back of the chair, one on the thorax over the sternum, one on the anterior superior iliac spine and one on the top of the homolateral thigh. Motion sensor data are sent by e-mail ( .csv file), together with a timeline (word file) of the occurrence of abnormal movements. They are sent pseudonymized simultaneously to Mike Dongelmans (ALU REHAB AS, Norway) and MotionCatch / Denmark (which carries out the analysis on behalf of ALU REHAB AS). In order to mark the "involuntary movement" events on the video, the collaborator will have to be able to identify which chair it is, but then, for the forward-slippage data analysis, this will be done under

    Time frame: End of the 3-hour period on Day 28

  5. Forward slippage in dynamic mode (PHASE B)

    Measurement of forward slippage (mm) of the pelvis in relation to the backrest of the chair. This assessment will be made after each involuntary movement over the 3-hour observation period.Collection tools/methods : Go pro positioning: see face + torso Sensor positioning: 4 motion sensors record continuously throughout the sequence: one on the back of the chair, one on the thorax over the sternum, one on the anterior superior iliac spine and one on the top of the homolateral thigh. Motion sensor data are sent by e-mail ( .csv file), together with a timeline (word file) of the occurrence of abnormal movements. They are sent pseudonymized simultaneously to Mike Dongelmans (ALU REHAB AS, Norway) and MotionCatch / Denmark (which carries out the analysis on behalf of ALU REHAB AS). In order to mark the "involuntary movement" events on the video, the collaborator will have to be able to identify which chair it is, but then, for the forward-slippage data analysis, this will be done under

    Time frame: End of the 3-hour period on Day 7

  6. Forward slippage in dynamic mode (PHASE B)

    Measurement of forward slippage (mm) of the pelvis in relation to the backrest of the chair. This assessment will be made after each involuntary movement over the 3-hour observation period.Collection tools/methods : Go pro positioning: see face + torso Sensor positioning: 4 motion sensors record continuously throughout the sequence: one on the back of the chair, one on the thorax over the sternum, one on the anterior superior iliac spine and one on the top of the homolateral thigh. Motion sensor data are sent by e-mail ( .csv file), together with a timeline (word file) of the occurrence of abnormal movements. They are sent pseudonymized simultaneously to Mike Dongelmans (ALU REHAB AS, Norway) and MotionCatch / Denmark (which carries out the analysis on behalf of ALU REHAB AS). In order to mark the "involuntary movement" events on the video, the collaborator will have to be able to identify which chair it is, but then, for the forward-slippage data analysis, this will be done under

    Time frame: End of the 3-hour period on Day 14

  7. Forward slippage in dynamic mode (PHASE B)

    Measurement of forward slippage (mm) of the pelvis in relation to the backrest of the chair. This assessment will be made after each involuntary movement over the 3-hour observation period.Collection tools/methods : Go pro positioning: see face + torso Sensor positioning: 4 motion sensors record continuously throughout the sequence: one on the back of the chair, one on the thorax over the sternum, one on the anterior superior iliac spine and one on the top of the homolateral thigh. Motion sensor data are sent by e-mail ( .csv file), together with a timeline (word file) of the occurrence of abnormal movements. They are sent pseudonymized simultaneously to Mike Dongelmans (ALU REHAB AS, Norway) and MotionCatch / Denmark (which carries out the analysis on behalf of ALU REHAB AS). In order to mark the "involuntary movement" events on the video, the collaborator will have to be able to identify which chair it is, but then, for the forward-slippage data analysis, this will be done under

    Time frame: End of the 3-hour period on Day 21

  8. Forward slippage in dynamic mode (PHASE B)

    Measurement of forward slippage (mm) of the pelvis in relation to the backrest of the chair. This assessment will be made after each involuntary movement over the 3-hour observation period.Collection tools/methods : Go pro positioning: see face + torso Sensor positioning: 4 motion sensors record continuously throughout the sequence: one on the back of the chair, one on the thorax over the sternum, one on the anterior superior iliac spine and one on the top of the homolateral thigh. Motion sensor data are sent by e-mail ( .csv file), together with a timeline (word file) of the occurrence of abnormal movements. They are sent pseudonymized simultaneously to Mike Dongelmans (ALU REHAB AS, Norway) and MotionCatch / Denmark (which carries out the analysis on behalf of ALU REHAB AS). In order to mark the "involuntary movement" events on the video, the collaborator will have to be able to identify which chair it is, but then, for the forward-slippage data analysis, this will be done under

    Time frame: End of the 3-hour period on Day 28

Secondary outcomes

  1. Peak force in static mode (PHASE A)

    Measurement of the peak force (F max ) exerted on the user's back during an involuntary movement. This assessment will be made after each involuntary movement over the 3-hour observation period.

    Time frame: After each involuntary movement over the 3-hour observation period on Day 7

  2. Peak force in static mode (PHASE A)

    Measurement of the peak force (F max ) exerted on the user's back during an involuntary movement. This assessment will be made after each involuntary movement over the 3-hour observation period.

    Time frame: After each involuntary movement over the 3-hour observation period on Day 14

  3. Peak force in static mode (PHASE A)

    Measurement of the peak force (F max ) exerted on the user's back during an involuntary movement. This assessment will be made after each involuntary movement over the 3-hour observation period.

    Time frame: After each involuntary movement over the 3-hour observation period on Day 21

  4. Peak force in static mode (PHASE A)

    Measurement of the peak force (F max ) exerted on the user's back during an involuntary movement. This assessment will be made after each involuntary movement over the 3-hour observation period.

    Time frame: After each involuntary movement over the 3-hour observation period on Day 28

  5. Peak force in dynamic mode (PHASE B)

    Measurement of the peak force (F max ) exerted on the user's back during an involuntary movement. This assessment will be made after each involuntary movement over the 3-hour observation period.

    Time frame: After each involuntary movement over the 3-hour observation period on Day 7

  6. Peak force in dynamic mode (PHASE B)

    Measurement of the peak force (F max ) exerted on the user's back during an involuntary movement. This assessment will be made after each involuntary movement over the 3-hour observation period.

    Time frame: After each involuntary movement over the 3-hour observation period on Day 14

  7. Peak force in dynamic mode (PHASE B)

    Measurement of the peak force (F max ) exerted on the user's back during an involuntary movement. This assessment will be made after each involuntary movement over the 3-hour observation period.

    Time frame: After each involuntary movement over the 3-hour observation period on Day 21

  8. Peak force in dynamic mode (PHASE B)

    Measurement of the peak force (F max ) exerted on the user's back during an involuntary movement. This assessment will be made after each involuntary movement over the 3-hour observation period.

    Time frame: After each involuntary movement over the 3-hour observation period on Day 28

  9. Maximum downward force in static mode (PHASE A)

    Measurement of the maximum downward force (Newton) exerted on the user's seat during an involuntary movement. This assessment will be made after each involuntary movement over the 3-hour observation period.

    Time frame: After each involuntary movement over the 3-hour observation period on Day 7

  10. Maximum downward force in static mode (PHASE A)

    Measurement of the maximum downward force (Newton) exerted on the user's seat during an involuntary movement. This assessment will be made after each involuntary movement over the 3-hour observation period.

    Time frame: After each involuntary movement over the 3-hour observation period on Day 14

  11. Maximum downward force in static mode (PHASE A)

    Measurement of the maximum downward force (Newton) exerted on the user's seat during an involuntary movement. This assessment will be made after each involuntary movement over the 3-hour observation period.

    Time frame: After each involuntary movement over the 3-hour observation period on Day 21

  12. Maximum downward force in static mode (PHASE A)

    Measurement of the maximum downward force (Newton) exerted on the user's seat during an involuntary movement. This assessment will be made after each involuntary movement over the 3-hour observation period.

    Time frame: After each involuntary movement over the 3-hour observation period on Day 28

  13. Maximum downward force in dynamic mode (PHASE B)

    Measurement of the maximum downward force (Newton) exerted on the user's seat during an involuntary movement. This assessment will be made after each involuntary movement over the 3-hour observation period.

    Time frame: After each involuntary movement over the 3-hour observation period on Day 7

  14. Maximum downward force in dynamic mode (PHASE B)

    Measurement of the maximum downward force (Newton) exerted on the user's seat during an involuntary movement. This assessment will be made after each involuntary movement over the 3-hour observation period.

    Time frame: After each involuntary movement over the 3-hour observation period on Day 14

  15. Maximum downward force in dynamic mode (PHASE B)

    Measurement of the maximum downward force (Newton) exerted on the user's seat during an involuntary movement. This assessment will be made after each involuntary movement over the 3-hour observation period.

    Time frame: After each involuntary movement over the 3-hour observation period on Day 21

  16. Maximum downward force in dynamic mode (PHASE B)

    Measurement of the maximum downward force (Newton) exerted on the user's seat during an involuntary movement. This assessment will be made after each involuntary movement over the 3-hour observation period.

    Time frame: After each involuntary movement over the 3-hour observation period on Day 28

  17. Patient's comfort in static mode (PHASE A)

    Self-assessment of the comfort felt by the patient when using the chair (Visual Analog Scale between 0 and 100mm) at the end of each measurement phase.

    Time frame: At the end of the 3-hour observation period on Day 7

  18. Patient's comfort in static mode (PHASE A)

    Self-assessment of the comfort felt by the patient when using the chair (Visual Analog Scale between 0 and 100mm) at the end of each measurement phase.

    Time frame: At the end of the 3-hour observation period on Day 14

  19. Patient's comfort in static mode (PHASE A)

    Self-assessment of the comfort felt by the patient when using the chair (Visual Analog Scale between 0 and 100mm) at the end of each measurement phase.

    Time frame: At the end of the 3-hour observation period on Day 21

  20. Patient's comfort in static mode (PHASE A)

    Self-assessment of the comfort felt by the patient when using the chair (Visual Analog Scale between 0 and 100mm) at the end of each measurement phase.

    Time frame: At the end of the 3-hour observation period on Day 28

  21. Patient's comfort in dynamic mode (PHASE B)

    Self-assessment of the comfort felt by the patient when using the chair (Visual Analog Scale between 0 and 100mm) at the end of each measurement phase.

    Time frame: At the end of the 3-hour observation period on Day 7

  22. Patient's comfort in dynamic mode (PHASE B)

    Self-assessment of the comfort felt by the patient when using the chair (Visual Analog Scale between 0 and 100mm) at the end of each measurement phase.

    Time frame: At the end of the 3-hour observation period on Day 14

  23. Patient's comfort in dynamic mode (PHASE B)

    Self-assessment of the comfort felt by the patient when using the chair (Visual Analog Scale between 0 and 100mm) at the end of each measurement phase.

    Time frame: At the end of the 3-hour observation period on Day 21

  24. Patient's comfort in dynamic mode (PHASE B)

    Self-assessment of the comfort felt by the patient when using the chair (Visual Analog Scale between 0 and 100mm) at the end of each measurement phase.

    Time frame: At the end of the 3-hour observation period on Day 28

  25. Caregiver's comfort in static mode (PHASE A)

    Hetero-assessment of the comfort felt by the patient's caregiver when using the chair (Visual Analog Scale between 0 and 100mm) at the end of each measurement phase.

    Time frame: At the end of the 3-hour observation period on Day 7

  26. Caregiver's comfort in dynamic mode (PHASE B)

    Hetero-assessment of the comfort felt by the patient's caregiver when using the chair (Visual Analog Scale between 0 and 100mm) at the end of each measurement phase.

    Time frame: At the end of the 3-hour observation period on Day 14

  27. Caregiver's comfort in dynamic mode (PHASE B)

    Hetero-assessment of the comfort felt by the patient's caregiver when using the chair (Visual Analog Scale between 0 and 100mm) at the end of each measurement phase.

    Time frame: At the end of the 3-hour observation period on Day 21

  28. Caregiver's comfort in dynamic mode (PHASE B)

    Hetero-assessment of the comfort felt by the patient's caregiver when using the chair (Visual Analog Scale between 0 and 100mm) at the end of each measurement phase.

    Time frame: At the end of the 3-hour observation period on Day 28

  29. Number of repositionings required in static mode (PHASE A)

    Number of repositionings required during the test phase.

    Time frame: At the end of the 3-hour observation period on Day 7

  30. Number of repositionings required in static mode (PHASE A)

    Number of repositionings required during the test phase.

    Time frame: At the end of the 3-hour observation period on Day 14

  31. Number of repositionings required in static mode (PHASE A)

    Number of repositionings required during the test phase.

    Time frame: At the end of the 3-hour observation period on Day 21

  32. Number of repositionings required in static mode (PHASE A)

    Number of repositionings required during the test phase.

    Time frame: At the end of the 3-hour observation period on Day 28

  33. Number of repositionings required in dynamic mode (PHASE B)

    Number of repositionings required during the test phase.

    Time frame: At the end of the 3-hour observation period on Day 7

  34. Number of repositionings required in dynamic mode (PHASE B)

    Number of repositionings required during the test phase.

    Time frame: At the end of the 3-hour observation period on Day 14

  35. Number of repositionings required in dynamic mode (PHASE B)

    Number of repositionings required during the test phase.

    Time frame: At the end of the 3-hour observation period on Day 21

  36. Number of repositionings required in dynamic mode (PHASE B)

    Number of repositionings required during the test phase.

    Time frame: At the end of the 3-hour observation period on Day 28

  37. Discomfort perceived by the caregiver in static mode (PHASE A)

    Caregiver's self-assessment of the discomfort felt over the observation period using a Visual Analog Scale scale from 0 to 100mm.

    Time frame: At the end of the 3-hour observation period on Day 7

  38. Discomfort perceived by the caregiver in static mode (PHASE A)

    Caregiver's self-assessment of the discomfort felt over the observation period using a Visual Analog Scale scale from 0 to 100mm.

    Time frame: At the end of the 3-hour observation period on Day 14

  39. Discomfort perceived by the caregiver in static mode (PHASE A)

    Caregiver's self-assessment of the discomfort felt over the observation period using a Visual Analog Scale scale from 0 to 100mm.

    Time frame: At the end of the 3-hour observation period on Day 21

  40. Discomfort perceived by the caregiver in static mode (PHASE A)

    Caregiver's self-assessment of the discomfort felt over the observation period using a Visual Analog Scale scale from 0 to 100mm.

    Time frame: At the end of the 3-hour observation period on Day 28

  41. Discomfort perceived by the caregiver in dynamic mode (PHASE B)

    Caregiver's self-assessment of the discomfort felt over the observation period using a Visual Analog Scale scale from 0 to 100mm.

    Time frame: At the end of the 3-hour observation period on Day 7

  42. Discomfort perceived by the caregiver in dynamic mode (PHASE B)

    Caregiver's self-assessment of the discomfort felt over the observation period using a Visual Analog Scale scale from 0 to 100mm.

    Time frame: At the end of the 3-hour observation period on Day 14

  43. Discomfort perceived by the caregiver in dynamic mode (PHASE B)

    Caregiver's self-assessment of the discomfort felt over the observation period using a Visual Analog Scale scale from 0 to 100mm.

    Time frame: At the end of the 3-hour observation period on Day 21

  44. Discomfort perceived by the caregiver in dynamic mode (PHASE B)

    Caregiver's self-assessment of the discomfort felt over the observation period using a Visual Analog Scale scale from 0 to 100mm.

    Time frame: At the end of the 3-hour observation period on Day 28

  45. Safety as perceived by the caregiver/carer in static mode (PHASE A)

    Hetero-evaluation by Visual Analog Scale scale (0-100mm) of the safety felt by the caregiver/carer when using the chair during the observation phase.

    Time frame: At the end of the 3-hour observation period on Day 7

  46. Safety as perceived by the caregiver/carer in static mode (PHASE A)

    Hetero-evaluation by Visual Analog Scale scale (0-100mm) of the safety felt by the caregiver/carer when using the chair during the observation phase.

    Time frame: At the end of the 3-hour observation period on Day 14

  47. Safety as perceived by the caregiver/carer in static mode (PHASE A)

    Hetero-evaluation by Visual Analog Scale scale (0-100mm) of the safety felt by the caregiver/carer when using the chair during the observation phase.

    Time frame: At the end of the 3-hour observation period on Day 21

  48. Safety as perceived by the caregiver/carer in static mode (PHASE A)

    Hetero-evaluation by Visual Analog Scale scale (0-100mm) of the safety felt by the caregiver/carer when using the chair during the observation phase.

    Time frame: At the end of the 3-hour observation period on Day 28

  49. Safety as perceived by the caregiver/carer in dynamic mode (PHASE B)

    Hetero-evaluation by Visual Analog Scale scale (0-100mm) of the safety felt by the caregiver/carer when using the chair during the observation phase.

    Time frame: At the end of the 3-hour observation period on Day 7

  50. Safety as perceived by the caregiver/carer in dynamic mode (PHASE B)

    Hetero-evaluation by Visual Analog Scale scale (0-100mm) of the safety felt by the caregiver/carer when using the chair during the observation phase.

    Time frame: At the end of the 3-hour observation period on Day 14

  51. Safety as perceived by the caregiver/carer in dynamic mode (PHASE B)

    Hetero-evaluation by Visual Analog Scale scale (0-100mm) of the safety felt by the caregiver/carer when using the chair during the observation phase.

    Time frame: At the end of the 3-hour observation period on Day 21

  52. Safety as perceived by the caregiver/carer in dynamic mode (PHASE B)

    Hetero-evaluation by Visual Analog Scale scale (0-100mm) of the safety felt by the caregiver/carer when using the chair during the observation phase.

    Time frame: At the end of the 3-hour observation period on Day 28

  53. Average of peak forces exerted on the wheelchair's backrest in static mode (PHASE A)

    Calculation of the average of the peak forces (Fmax) exerted on the rear support of the wheelchair.

    Time frame: At the end of the 3-hour observation period on Day 7

  54. Average of peak forces exerted on the wheelchair's backrest in static mode (PHASE A)

    Calculation of the average of the peak forces (Fmax) exerted on the rear support of the wheelchair.

    Time frame: At the end of the 3-hour observation period on Day 14

  55. Average of peak forces exerted on the wheelchair's backrest in static mode (PHASE A)

    Calculation of the average of the peak forces (Fmax) exerted on the rear support of the wheelchair.

    Time frame: At the end of the 3-hour observation period on Day 21

  56. Average of peak forces exerted on the wheelchair's backrest in static mode (PHASE A)

    Calculation of the average of the peak forces (Fmax) exerted on the rear support of the wheelchair.

    Time frame: At the end of the 3-hour observation period on Day 28

  57. Average of peak forces exerted on the wheelchair's backrest in dynamic mode (PHASE B)

    Calculation of the average of the peak forces (Fmax) exerted on the rear support of the wheelchair.

    Time frame: At the end of the 3-hour observation period on Day 7

  58. Average of peak forces exerted on the wheelchair's backrest in dynamic mode (PHASE B)

    Calculation of the average of the peak forces (Fmax) exerted on the rear support of the wheelchair.

    Time frame: At the end of the 3-hour observation period on Day 14

  59. Average of peak forces exerted on the wheelchair's backrest in dynamic mode (PHASE B)

    Calculation of the average of the peak forces (Fmax) exerted on the rear support of the wheelchair.

    Time frame: At the end of the 3-hour observation period on Day 21

  60. Average of peak forces exerted on the wheelchair's backrest in dynamic mode (PHASE B)

    Calculation of the average of the peak forces (Fmax) exerted on the rear support of the wheelchair.

    Time frame: At the end of the 3-hour observation period on Day 28

  61. Average of peak forces exerted on the wheelchair's seat in static mode (PHASE A)

    Calculation of the average of the peak forces (Fmax) exerted on the seat of the wheelchair measured for all involuntary movements.

    Time frame: At the end of the 3-hour observation period on Day 7

  62. Average of peak forces exerted on the wheelchair's seat in static mode (PHASE A)

    Calculation of the average of the peak forces (Fmax) exerted on the seat of the wheelchair measured for all involuntary movements.

    Time frame: At the end of the 3-hour observation period on Day 14

  63. Average of peak forces exerted on the wheelchair's seat in static mode (PHASE A)

    Calculation of the average of the peak forces (Fmax) exerted on the seat of the wheelchair measured for all involuntary movements.

    Time frame: At the end of the 3-hour observation period on Day 21

  64. Average of peak forces exerted on the wheelchair's seat in static mode (PHASE A)

    Calculation of the average of the peak forces (Fmax) exerted on the seat of the wheelchair measured for all involuntary movements.

    Time frame: At the end of the 3-hour observation period on Day 28

  65. Average of peak forces exerted on the wheelchair's seat in dynamic mode (PHASE B)

    Calculation of the average of the peak forces (Fmax) exerted on the seat of the wheelchair measured for all involuntary movements.

    Time frame: At the end of the 3-hour observation period on Day 7

  66. Average of peak forces exerted on the wheelchair's seat in dynamic mode (PHASE B)

    Calculation of the average of the peak forces (Fmax) exerted on the seat of the wheelchair measured for all involuntary movements.

    Time frame: At the end of the 3-hour observation period on Day 14

  67. Average of peak forces exerted on the wheelchair's seat in dynamic mode (PHASE B)

    Calculation of the average of the peak forces (Fmax) exerted on the seat of the wheelchair measured for all involuntary movements.

    Time frame: At the end of the 3-hour observation period on Day 21

  68. Average of peak forces exerted on the wheelchair's seat in dynamic mode (PHASE B)

    Calculation of the average of the peak forces (Fmax) exerted on the seat of the wheelchair measured for all involuntary movements.

    Time frame: At the end of the 3-hour observation period on Day 28

Other outcomes

  1. Sex

    The sex of each patient will be recorded as MALE/FEMALE/NON-BINARY

    Time frame: Day 0

  2. Age

    The age of each patient will be recorded in YEARS

    Time frame: Day 0

  3. Height

    The height of each patient will be recorded in centimeters

    Time frame: Day 0

  4. Weight

    The weight of each patient will be recorded in kilograms

    Time frame: Day 0

  5. Body mass index

    The patient's body mass index (= kg/m2 ) will be calculated via a computerized procedure.

    Time frame: Day 0

07

Study locations

1 site
  • CHU de Nîmes
    Nîmes, 30029, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06351189
Lead sponsor
Centre Hospitalier Universitaire de Nīmes
Responsible party
Sponsor
First posted
Apr 8, 2024
Start date
Mar 19, 2024
Primary completion
Dec 5, 2024
Completion
Dec 5, 2024
Last update
Dec 5, 2025

Study contacts

Anissa MEGZARI
study director · Centre Hospitalier Universitaire de Nīmes

Oversight

FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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