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

Centre Hospitalier Universitaire de Nīmes4 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

Interventions

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.

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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

Locations (1)

CHU de Nîmes

Nîmes, France

Outcomes

Primary Outcomes

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

Forward slippage in static mode (PHASE A)

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

Forward slippage in static mode (PHASE A)

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

Forward slippage in static mode (PHASE A)

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

Forward slippage in dynamic mode (PHASE B)

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

Forward slippage in dynamic mode (PHASE B)

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

Forward slippage in dynamic mode (PHASE B)

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

Forward slippage in dynamic mode (PHASE B)

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

Secondary Outcomes

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

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

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

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

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

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

Data from ClinicalTrials.gov

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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

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

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

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)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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.