Clinical trial NCT06351189: NETTI Wheelchair: Does Dynamic Mode or Static Mode Affect the Sitting Position in Patients with Involuntary Movements ?
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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hyperextension Spasms
Involuntary Movements
Keywords: Wheelchair
Single-case experimental design
Hyperextension spasms
Positioning
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2024-04-08
Enrollment: 5
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility criteria: 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:

* 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

Primary outcomes:
measure: Forward slippage in static mode (PHASE A)
timeFrame: End of the 3-hour period on Day 7
measure: Forward slippage in static mode (PHASE A)
timeFrame: End of the 3-hour period on Day 14
measure: Forward slippage in static mode (PHASE A)
timeFrame: End of the 3-hour period on Day 21
measure: Forward slippage in static mode (PHASE A)
timeFrame: End of the 3-hour period on Day 28
measure: Forward slippage in dynamic mode (PHASE B)
timeFrame: End of the 3-hour period on Day 7
measure: Forward slippage in dynamic mode (PHASE B)
timeFrame: End of the 3-hour period on Day 14
measure: Forward slippage in dynamic mode (PHASE B)
timeFrame: End of the 3-hour period on Day 21
measure: Forward slippage in dynamic mode (PHASE B)
timeFrame: End of the 3-hour period on Day 28
Secondary outcomes:
measure: Peak force in static mode (PHASE A)
timeFrame: After each involuntary movement over the 3-hour observation period on Day 7
measure: Peak force in static mode (PHASE A)
timeFrame: After each involuntary movement over the 3-hour observation period on Day 14
measure: Peak force in static mode (PHASE A)
timeFrame: After each involuntary movement over the 3-hour observation period on Day 21
measure: Peak force in static mode (PHASE A)
timeFrame: After each involuntary movement over the 3-hour observation period on Day 28
measure: Peak force in dynamic mode (PHASE B)
timeFrame: After each involuntary movement over the 3-hour observation period on Day 7
measure: Peak force in dynamic mode (PHASE B)
timeFrame: After each involuntary movement over the 3-hour observation period on Day 14
measure: Peak force in dynamic mode (PHASE B)
timeFrame: After each involuntary movement over the 3-hour observation period on Day 21
measure: Peak force in dynamic mode (PHASE B)
timeFrame: After each involuntary movement over the 3-hour observation period on Day 28
measure: Maximum downward force in static mode (PHASE A)
timeFrame: After each involuntary movement over the 3-hour observation period on Day 7
measure: Maximum downward force in static mode (PHASE A)
timeFrame: After each involuntary movement over the 3-hour observation period on Day 14
measure: Maximum downward force in static mode (PHASE A)
timeFrame: After each involuntary movement over the 3-hour observation period on Day 21
measure: Maximum downward force in static mode (PHASE A)
timeFrame: After each involuntary movement over the 3-hour observation period on Day 28
measure: Maximum downward force in dynamic mode (PHASE B)
timeFrame: After each involuntary movement over the 3-hour observation period on Day 7
measure: Maximum downward force in dynamic mode (PHASE B)
timeFrame: After each involuntary movement over the 3-hour observation period on Day 14
measure: Maximum downward force in dynamic mode (PHASE B)
timeFrame: After each involuntary movement over the 3-hour observation period on Day 21
measure: Maximum downward force in dynamic mode (PHASE B)
timeFrame: After each involuntary movement over the 3-hour observation period on Day 28
measure: Patient's comfort in static mode (PHASE A)
timeFrame: At the end of the 3-hour observation period on Day 7
measure: Patient's comfort in static mode (PHASE A)
timeFrame: At the end of the 3-hour observation period on Day 14
measure: Patient's comfort in static mode (PHASE A)
timeFrame: At the end of the 3-hour observation period on Day 21
measure: Patient's comfort in static mode (PHASE A)
timeFrame: At the end of the 3-hour observation period on Day 28
measure: Patient's comfort in dynamic mode (PHASE B)
timeFrame: At the end of the 3-hour observation period on Day 7
measure: Patient's comfort in dynamic mode (PHASE B)
timeFrame: At the end of the 3-hour observation period on Day 14
measure: Patient's comfort in dynamic mode (PHASE B)
timeFrame: At the end of the 3-hour observation period on Day 21
measure: Patient's comfort in dynamic mode (PHASE B)
timeFrame: At the end of the 3-hour observation period on Day 28
measure: Caregiver's comfort in static mode (PHASE A)
timeFrame: At the end of the 3-hour observation period on Day 7
measure: Caregiver's comfort in dynamic mode (PHASE B)
timeFrame: At the end of the 3-hour observation period on Day 14
measure: Caregiver's comfort in dynamic mode (PHASE B)
timeFrame: At the end of the 3-hour observation period on Day 21
measure: Caregiver's comfort in dynamic mode (PHASE B)
timeFrame: At the end of the 3-hour observation period on Day 28
measure: Number of repositionings required in static mode (PHASE A)
timeFrame: At the end of the 3-hour observation period on Day 7
measure: Number of repositionings required in static mode (PHASE A)
timeFrame: At the end of the 3-hour observation period on Day 14
measure: Number of repositionings required in static mode (PHASE A)
timeFrame: At the end of the 3-hour observation period on Day 21
measure: Number of repositionings required in static mode (PHASE A)
timeFrame: At the end of the 3-hour observation period on Day 28
measure: Number of repositionings required in dynamic mode (PHASE B)
timeFrame: At the end of the 3-hour observation period on Day 7
measure: Number of repositionings required in dynamic mode (PHASE B)
timeFrame: At the end of the 3-hour observation period on Day 14
measure: Number of repositionings required in dynamic mode (PHASE B)
timeFrame: At the end of the 3-hour observation period on Day 21
measure: Number of repositionings required in dynamic mode (PHASE B)
timeFrame: At the end of the 3-hour observation period on Day 28
measure: Discomfort perceived by the caregiver in static mode (PHASE A)
timeFrame: At the end of the 3-hour observation period on Day 7
measure: Discomfort perceived by the caregiver in static mode (PHASE A)
timeFrame: At the end of the 3-hour observation period on Day 14
measure: Discomfort perceived by the caregiver in static mode (PHASE A)
timeFrame: At the end of the 3-hour observation period on Day 21
measure: Discomfort perceived by the caregiver in static mode (PHASE A)
timeFrame: At the end of the 3-hour observation period on Day 28
measure: Discomfort perceived by the caregiver in dynamic mode (PHASE B)
timeFrame: At the end of the 3-hour observation period on Day 7
measure: Discomfort perceived by the caregiver in dynamic mode (PHASE B)
timeFrame: At the end of the 3-hour observation period on Day 14
measure: Discomfort perceived by the caregiver in dynamic mode (PHASE B)
timeFrame: At the end of the 3-hour observation period on Day 21
measure: Discomfort perceived by the caregiver in dynamic mode (PHASE B)
timeFrame: At the end of the 3-hour observation period on Day 28
measure: Safety as perceived by the caregiver/carer in static mode (PHASE A)
timeFrame: At the end of the 3-hour observation period on Day 7
measure: Safety as perceived by the caregiver/carer in static mode (PHASE A)
timeFrame: At the end of the 3-hour observation period on Day 14
measure: Safety as perceived by the caregiver/carer in static mode (PHASE A)
timeFrame: At the end of the 3-hour observation period on Day 21
measure: Safety as perceived by the caregiver/carer in static mode (PHASE A)
timeFrame: At the end of the 3-hour observation period on Day 28
measure: Safety as perceived by the caregiver/carer in dynamic mode (PHASE B)
timeFrame: At the end of the 3-hour observation period on Day 7
measure: Safety as perceived by the caregiver/carer in dynamic mode (PHASE B)
timeFrame: At the end of the 3-hour observation period on Day 14
measure: Safety as perceived by the caregiver/carer in dynamic mode (PHASE B)
timeFrame: At the end of the 3-hour observation period on Day 21
measure: Safety as perceived by the caregiver/carer in dynamic mode (PHASE B)
timeFrame: At the end of the 3-hour observation period on Day 28
measure: Average of peak forces exerted on the wheelchair's backrest in static mode (PHASE A)
timeFrame: At the end of the 3-hour observation period on Day 7
measure: Average of peak forces exerted on the wheelchair's backrest in static mode (PHASE A)
timeFrame: At the end of the 3-hour observation period on Day 14
measure: Average of peak forces exerted on the wheelchair's backrest in static mode (PHASE A)
timeFrame: At the end of the 3-hour observation period on Day 21
measure: Average of peak forces exerted on the wheelchair's backrest in static mode (PHASE A)
timeFrame: At the end of the 3-hour observation period on Day 28
measure: Average of peak forces exerted on the wheelchair's backrest in dynamic mode (PHASE B)
timeFrame: At the end of the 3-hour observation period on Day 7
measure: Average of peak forces exerted on the wheelchair's backrest in dynamic mode (PHASE B)
timeFrame: At the end of the 3-hour observation period on Day 14
measure: Average of peak forces exerted on the wheelchair's backrest in dynamic mode (PHASE B)
timeFrame: At the end of the 3-hour observation period on Day 21
measure: Average of peak forces exerted on the wheelchair's backrest in dynamic mode (PHASE B)
timeFrame: At the end of the 3-hour observation period on Day 28
measure: Average of peak forces exerted on the wheelchair's seat in static mode (PHASE A)
timeFrame: At the end of the 3-hour observation period on Day 7
measure: Average of peak forces exerted on the wheelchair's seat in static mode (PHASE A)
timeFrame: At the end of the 3-hour observation period on Day 14
measure: Average of peak forces exerted on the wheelchair's seat in static mode (PHASE A)
timeFrame: At the end of the 3-hour observation period on Day 21
measure: Average of peak forces exerted on the wheelchair's seat in static mode (PHASE A)
timeFrame: At the end of the 3-hour observation period on Day 28
measure: Average of peak forces exerted on the wheelchair's seat in dynamic mode (PHASE B)
timeFrame: At the end of the 3-hour observation period on Day 7
measure: Average of peak forces exerted on the wheelchair's seat in dynamic mode (PHASE B)
timeFrame: At the end of the 3-hour observation period on Day 14
measure: Average of peak forces exerted on the wheelchair's seat in dynamic mode (PHASE B)
timeFrame: At the end of the 3-hour observation period on Day 21
measure: Average of peak forces exerted on the wheelchair's seat in dynamic mode (PHASE B)
timeFrame: At the end of the 3-hour observation period on Day 28
Other outcomes:
measure: Sex
timeFrame: Day 0
measure: Age
timeFrame: Day 0
measure: Height
timeFrame: Day 0
measure: Weight
timeFrame: Day 0
measure: Body mass index
timeFrame: Day 0
Locations:
city: Nîmes
country: France
facility: CHU de Nîmes
Study officials:
affiliation: Centre Hospitalier Universitaire de Nīmes
name: Anissa MEGZARI
role: STUDY_DIRECTOR
References: