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

NCT06351189 | Completed

• 1 other identifier: CIVI/2022/AD-01
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Hyperextension Spasms; Involuntary Movements

Keywords

Wheelchair; Single-case experimental design; Hyperextension spasms; Positioning

Outcome Measures

Primary Outcomes (8)

• 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

  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

  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

  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

  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

  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

  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

  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

  End of the 3-hour period on Day 28

Secondary Outcomes (68)

• Peak force in static mode (PHASE A)

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

• Peak force in static mode (PHASE A)

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

• Peak force in static mode (PHASE A)

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

• Peak force in static mode (PHASE A)

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

• Peak force in dynamic mode (PHASE B)

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

Other Outcomes (5)

• Sex

  Day 0

• Age

  Day 0

• Height

  Day 0

Study Arms (2)

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

Observation DEVICE

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.

Control group: STATIC MODE; Interventional group: DYNAMIC MODE

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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/legal representative for whom it is impossible to provide informed information.
• Pregnant or breast-feeding patient

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nîmes

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Dyskinesias

Interventions

Observation

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Anissa MEGZARI

  Centre Hospitalier Universitaire de Nīmes

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 8, 2024
• Study Start: March 19, 2024
• Primary Completion: December 5, 2024
• Study Completion: December 5, 2024
• Last Updated: December 5, 2025

Record last verified: 2025-12

Locations

FR (1)