Hyperextension SpasmsDYNAMIC SYSTEMNCT06351189
NETTI Wheelchair: Does Dynamic Mode or Static Mode Affect the Sitting Position in Patients With Involuntary Movements ?
An observational study of Hyperextension Spasms and Involuntary Movements, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Hyperextension Spasms, Involuntary Movements
- What is being tested?
- Observation
- Type of treatment
- Medical device
- How many people
- 4 participants
- Where
- 1 siteFrance
- Study dates
- 19 Mar 2024to 5 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Performance Evaluation of the NETTI Wheelchair in Dynamic Mode for Subjects With Involuntary Movements With an Impact on Sitting Position Compared With Its Static Mode. Single-case Experimental Design.
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.
- Conditions
- Hyperextension Spasms, Involuntary Movements
- Being tested
- Observation
- Keywords
- Wheelchair, Single-case experimental design, Hyperextension spasms, Positioning
- Medical subject headings
- Dyskinesias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group: STATIC MODE | The patient will be positioned on the Netti Dynamic chair in static mode. Receives: Device: Observation | |
| Interventional group: DYNAMIC MODE | The patient will be positioned on the Netti Dynamic chair in dynamic mode. Receives: Device: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: End of the 3-hour period on Day 7
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
Measured: End of the 3-hour period on Day 14
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
Measured: End of the 3-hour period on Day 21
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
Measured: End of the 3-hour period on Day 28
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
Measured: End of the 3-hour period on Day 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
Measured: End of the 3-hour period on Day 14
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
Measured: End of the 3-hour period on Day 21
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
Measured: End of the 3-hour period on Day 28
Secondary outcomes (68)
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.
Measured: After each involuntary movement over the 3-hour observation period on Day 7
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.
Measured: After each involuntary movement over the 3-hour observation period on Day 14
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.
Measured: After each involuntary movement over the 3-hour observation period on Day 21
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.
Measured: After each involuntary movement over the 3-hour observation period on Day 28
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.
Measured: After each involuntary movement over the 3-hour observation period on Day 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.
Measured: After each involuntary movement over the 3-hour observation period on Day 14
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.
Measured: After each involuntary movement over the 3-hour observation period on Day 21
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.
Measured: After each involuntary movement over the 3-hour observation period on Day 28
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.
Measured: After each involuntary movement over the 3-hour observation period on Day 7
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.
Measured: After each involuntary movement over the 3-hour observation period on Day 14
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.
Measured: After each involuntary movement over the 3-hour observation period on Day 21
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.
Measured: After each involuntary movement over the 3-hour observation period on Day 28
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.
Measured: After each involuntary movement over the 3-hour observation period on Day 7
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.
Measured: After each involuntary movement over the 3-hour observation period on Day 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.
Measured: After each involuntary movement over the 3-hour observation period on Day 21
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.
Measured: After each involuntary movement over the 3-hour observation period on Day 28
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.
Measured: At the end of the 3-hour observation period on Day 7
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.
Measured: At the end of the 3-hour observation period on Day 14
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.
Measured: At the end of the 3-hour observation period on Day 21
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.
Measured: At the end of the 3-hour observation period on Day 28
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.
Measured: At the end of the 3-hour observation period on Day 7
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.
Measured: At the end of the 3-hour observation period on Day 14
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.
Measured: At the end of the 3-hour observation period on Day 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.
Measured: At the end of the 3-hour observation period on Day 28
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.
Measured: At the end of the 3-hour observation period on Day 7
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.
Measured: At the end of the 3-hour observation period on Day 14
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.
Measured: At the end of the 3-hour observation period on Day 21
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.
Measured: At the end of the 3-hour observation period on Day 28
Number of repositionings required in static mode (PHASE A)
Number of repositionings required during the test phase.
Measured: At the end of the 3-hour observation period on Day 7
Number of repositionings required in static mode (PHASE A)
Number of repositionings required during the test phase.
Measured: At the end of the 3-hour observation period on Day 14
Number of repositionings required in static mode (PHASE A)
Number of repositionings required during the test phase.
Measured: At the end of the 3-hour observation period on Day 21
Number of repositionings required in static mode (PHASE A)
Number of repositionings required during the test phase.
Measured: At the end of the 3-hour observation period on Day 28
Number of repositionings required in dynamic mode (PHASE B)
Number of repositionings required during the test phase.
Measured: At the end of the 3-hour observation period on Day 7
Number of repositionings required in dynamic mode (PHASE B)
Number of repositionings required during the test phase.
Measured: At the end of the 3-hour observation period on Day 14
Number of repositionings required in dynamic mode (PHASE B)
Number of repositionings required during the test phase.
Measured: At the end of the 3-hour observation period on Day 21
Number of repositionings required in dynamic mode (PHASE B)
Number of repositionings required during the test phase.
Measured: At the end of the 3-hour observation period on Day 28
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.
Measured: At the end of the 3-hour observation period on Day 7
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.
Measured: At the end of the 3-hour observation period on Day 14
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.
Measured: At the end of the 3-hour observation period on Day 21
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.
Measured: At the end of the 3-hour observation period on Day 28
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.
Measured: At the end of the 3-hour observation period on Day 7
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.
Measured: At the end of the 3-hour observation period on Day 14
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.
Measured: At the end of the 3-hour observation period on Day 21
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.
Measured: At the end of the 3-hour observation period on Day 28
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.
Measured: At the end of the 3-hour observation period on Day 7
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.
Measured: At the end of the 3-hour observation period on Day 14
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.
Measured: At the end of the 3-hour observation period on Day 21
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.
Measured: At the end of the 3-hour observation period on Day 28
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.
Measured: At the end of the 3-hour observation period on Day 7
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.
Measured: At the end of the 3-hour observation period on Day 14
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.
Measured: At the end of the 3-hour observation period on Day 21
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.
Measured: At the end of the 3-hour observation period on Day 28
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.
Measured: At the end of the 3-hour observation period on Day 7
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.
Measured: At the end of the 3-hour observation period on Day 14
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.
Measured: At the end of the 3-hour observation period on Day 21
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.
Measured: At the end of the 3-hour observation period on Day 28
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.
Measured: At the end of the 3-hour observation period on Day 7
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.
Measured: At the end of the 3-hour observation period on Day 14
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.
Measured: At the end of the 3-hour observation period on Day 21
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.
Measured: At the end of the 3-hour observation period on Day 28
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.
Measured: At the end of the 3-hour observation period on Day 7
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.
Measured: At the end of the 3-hour observation period on Day 14
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.
Measured: At the end of the 3-hour observation period on Day 21
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.
Measured: At the end of the 3-hour observation period on Day 28
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.
Measured: At the end of the 3-hour observation period on Day 7
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.
Measured: At the end of the 3-hour observation period on Day 14
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.
Measured: At the end of the 3-hour observation period on Day 21
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.
Measured: At the end of the 3-hour observation period on Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start19 Mar 2024
- Primary completion5 Dec 2024
- Study completion5 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperextension SpasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anissa MEGZARI, Study director, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06351189
- Sponsor's protocol ID
- CIVI/2022/AD-01
- Acronym
- DYNAMIC SYSTEM
- Status last verified
- Dec 2025
- First submitted
- 2 Apr 2024
- Last updated
- 5 Dec 2025
- Results posted
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Evaluation of the NETTI Wheelchair in Dynamic Mode for Subjects With Involuntary Movements With an Impact on Sitting Position Compared With Its Static Mode. Single-case Experimental Design.
- ClinicalTrials.gov ID
- NCT06351189
- Acronym / sponsor ID
- DYNAMIC SYSTEM / CIVI/2022/AD-01
- Conditions
- Hyperextension Spasms, Involuntary Movements
- Keywords
- Wheelchair, Single-case experimental design, Hyperextension spasms, Positioning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 19 Mar 2024 (actual)
- Primary completion
- 5 Dec 2024 (actual)
- Study completion
- 5 Dec 2024 (actual)
- First posted
- 8 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group: STATIC MODE | – | Device: ObservationThe patient will be positioned on the Netti Dynamic chair in static mode. |
| Interventional group: DYNAMIC MODE | – | Device: ObservationThe patient will be positioned on the Netti Dynamic chair in dynamic mode. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationPatients 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. | Device | Control group: STATIC MODE, Interventional group: DYNAMIC MODE |
Primary outcome
Forward slippage in static mode (PHASE A)
Time frame: End of the 3-hour period on Day 7
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
Forward slippage in static mode (PHASE A)
Time frame: End of the 3-hour period on Day 14
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
Forward slippage in static mode (PHASE A)
Time frame: End of the 3-hour period on Day 21
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
Forward slippage in static mode (PHASE A)
Time frame: End of the 3-hour period on Day 28
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
Forward slippage in dynamic mode (PHASE B)
Time frame: End of the 3-hour period on Day 7
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
Forward slippage in dynamic mode (PHASE B)
Time frame: End of the 3-hour period on Day 14
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
Forward slippage in dynamic mode (PHASE B)
Time frame: End of the 3-hour period on Day 21
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
Forward slippage in dynamic mode (PHASE B)
Time frame: End of the 3-hour period on Day 28
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
68 secondary outcomes
Peak force in static mode (PHASE A)
Time frame: After each involuntary movement over the 3-hour observation period on Day 7
Peak force in static mode (PHASE A)
Time frame: After each involuntary movement over the 3-hour observation period on Day 14
Peak force in static mode (PHASE A)
Time frame: After each involuntary movement over the 3-hour observation period on Day 21
Peak force in static mode (PHASE A)
Time frame: After each involuntary movement over the 3-hour observation period on Day 28
Peak force in dynamic mode (PHASE B)
Time frame: After each involuntary movement over the 3-hour observation period on Day 7
Peak force in dynamic mode (PHASE B)
Time frame: After each involuntary movement over the 3-hour observation period on Day 14
Peak force in dynamic mode (PHASE B)
Time frame: After each involuntary movement over the 3-hour observation period on Day 21
Peak force in dynamic mode (PHASE B)
Time frame: After each involuntary movement over the 3-hour observation period on Day 28
Maximum downward force in static mode (PHASE A)
Time frame: After each involuntary movement over the 3-hour observation period on Day 7
Maximum downward force in static mode (PHASE A)
Time frame: After each involuntary movement over the 3-hour observation period on Day 14
Maximum downward force in static mode (PHASE A)
Time frame: After each involuntary movement over the 3-hour observation period on Day 21
Maximum downward force in static mode (PHASE A)
Time frame: After each involuntary movement over the 3-hour observation period on Day 28
Maximum downward force in dynamic mode (PHASE B)
Time frame: After each involuntary movement over the 3-hour observation period on Day 7
Maximum downward force in dynamic mode (PHASE B)
Time frame: After each involuntary movement over the 3-hour observation period on Day 14
Maximum downward force in dynamic mode (PHASE B)
Time frame: After each involuntary movement over the 3-hour observation period on Day 21
Maximum downward force in dynamic mode (PHASE B)
Time frame: After each involuntary movement over the 3-hour observation period on Day 28
Patient's comfort in static mode (PHASE A)
Time frame: At the end of the 3-hour observation period on Day 7
Patient's comfort in static mode (PHASE A)
Time frame: At the end of the 3-hour observation period on Day 14
Patient's comfort in static mode (PHASE A)
Time frame: At the end of the 3-hour observation period on Day 21
Patient's comfort in static mode (PHASE A)
Time frame: At the end of the 3-hour observation period on Day 28
Patient's comfort in dynamic mode (PHASE B)
Time frame: At the end of the 3-hour observation period on Day 7
Patient's comfort in dynamic mode (PHASE B)
Time frame: At the end of the 3-hour observation period on Day 14
Patient's comfort in dynamic mode (PHASE B)
Time frame: At the end of the 3-hour observation period on Day 21
Patient's comfort in dynamic mode (PHASE B)
Time frame: At the end of the 3-hour observation period on Day 28
Caregiver's comfort in static mode (PHASE A)
Time frame: At the end of the 3-hour observation period on Day 7
Caregiver's comfort in dynamic mode (PHASE B)
Time frame: At the end of the 3-hour observation period on Day 14
Caregiver's comfort in dynamic mode (PHASE B)
Time frame: At the end of the 3-hour observation period on Day 21
Caregiver's comfort in dynamic mode (PHASE B)
Time frame: At the end of the 3-hour observation period on Day 28
Number of repositionings required in static mode (PHASE A)
Time frame: At the end of the 3-hour observation period on Day 7
Number of repositionings required in static mode (PHASE A)
Time frame: At the end of the 3-hour observation period on Day 14
Number of repositionings required in static mode (PHASE A)
Time frame: At the end of the 3-hour observation period on Day 21
Number of repositionings required in static mode (PHASE A)
Time frame: At the end of the 3-hour observation period on Day 28
Number of repositionings required in dynamic mode (PHASE B)
Time frame: At the end of the 3-hour observation period on Day 7
Number of repositionings required in dynamic mode (PHASE B)
Time frame: At the end of the 3-hour observation period on Day 14
Number of repositionings required in dynamic mode (PHASE B)
Time frame: At the end of the 3-hour observation period on Day 21
Number of repositionings required in dynamic mode (PHASE B)
Time frame: At the end of the 3-hour observation period on Day 28
Discomfort perceived by the caregiver in static mode (PHASE A)
Time frame: At the end of the 3-hour observation period on Day 7
Discomfort perceived by the caregiver in static mode (PHASE A)
Time frame: At the end of the 3-hour observation period on Day 14
Discomfort perceived by the caregiver in static mode (PHASE A)
Time frame: At the end of the 3-hour observation period on Day 21
Discomfort perceived by the caregiver in static mode (PHASE A)
Time frame: At the end of the 3-hour observation period on Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anissa MEGZARI study director
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperextension Spasms and Involuntary Movements, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forward slippage in static mode (PHASE A) (time frame: End of the 3-hour period on Day 7). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.