protocolSection identificationModule nctId: NCT06351189, orgStudyIdInfo id: CIVI/2022/AD-01, briefTitle: NETTI Wheelchair: Does Dynamic Mode or Static Mode Affect the Sitting Position in Patients With Involuntary Movements ?, acronym: DYNAMIC SYSTEM, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2026-08-01, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-08, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire de Nīmes, class: OTHER, descriptionModule briefSummary: 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, conditionsModule conditions: Hyperextension Spasms, conditions: Involuntary Movements, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 5, type: ESTIMATED, armsInterventionsModule interventions name: Observation, outcomesModule primaryOutcomes measure: Forward slippage in static mode (PHASE A), primaryOutcomes measure: Forward slippage in static mode (PHASE A), primaryOutcomes measure: Forward slippage in static mode (PHASE A), primaryOutcomes measure: Forward slippage in static mode (PHASE A), primaryOutcomes measure: Forward slippage in dynamic mode (PHASE B), primaryOutcomes measure: Forward slippage in dynamic mode (PHASE B), primaryOutcomes measure: Forward slippage in dynamic mode (PHASE B), primaryOutcomes measure: Forward slippage in dynamic mode (PHASE B), secondaryOutcomes measure: Peak force in static mode (PHASE A), secondaryOutcomes measure: Peak force in static mode (PHASE A), secondaryOutcomes measure: Peak force in static mode (PHASE A), secondaryOutcomes measure: Peak force in static mode (PHASE A), secondaryOutcomes measure: Peak force in dynamic mode (PHASE B), secondaryOutcomes measure: Peak force in dynamic mode (PHASE B), secondaryOutcomes measure: Peak force in dynamic mode (PHASE B), secondaryOutcomes measure: Peak force in dynamic mode (PHASE B), secondaryOutcomes measure: Maximum downward force in static mode (PHASE A), secondaryOutcomes measure: Maximum downward force in static mode (PHASE A), secondaryOutcomes measure: Maximum downward force in static mode (PHASE A), secondaryOutcomes measure: Maximum downward force in static mode (PHASE A), secondaryOutcomes measure: Maximum downward force in dynamic mode (PHASE B), secondaryOutcomes measure: Maximum downward force in dynamic mode (PHASE B), secondaryOutcomes measure: Maximum downward force in dynamic mode (PHASE B), secondaryOutcomes measure: Maximum downward force in dynamic mode (PHASE B), secondaryOutcomes measure: Patient's comfort in static mode (PHASE A), secondaryOutcomes measure: Patient's comfort in static mode (PHASE A), secondaryOutcomes measure: Patient's comfort in static mode (PHASE A), secondaryOutcomes measure: Patient's comfort in static mode (PHASE A), secondaryOutcomes measure: Patient's comfort in dynamic mode (PHASE B), secondaryOutcomes measure: Patient's comfort in dynamic mode (PHASE B), secondaryOutcomes measure: Patient's comfort in dynamic mode (PHASE B), secondaryOutcomes measure: Patient's comfort in dynamic mode (PHASE B), secondaryOutcomes measure: Caregiver's comfort in static mode (PHASE A), secondaryOutcomes measure: Caregiver's comfort in dynamic mode (PHASE B), secondaryOutcomes measure: Caregiver's comfort in dynamic mode (PHASE B), secondaryOutcomes measure: Caregiver's comfort in dynamic mode (PHASE B), secondaryOutcomes measure: Number of repositionings required in static mode (PHASE A), secondaryOutcomes measure: Number of repositionings required in static mode (PHASE A), secondaryOutcomes measure: Number of repositionings required in static mode (PHASE A), secondaryOutcomes measure: Number of repositionings required in static mode (PHASE A), secondaryOutcomes measure: Number of repositionings required in dynamic mode (PHASE B), secondaryOutcomes measure: Number of repositionings required in dynamic mode (PHASE B), secondaryOutcomes measure: Number of repositionings required in dynamic mode (PHASE B), secondaryOutcomes measure: Number of repositionings required in dynamic mode (PHASE B), secondaryOutcomes measure: Discomfort perceived by the caregiver in static mode (PHASE A), secondaryOutcomes measure: Discomfort perceived by the caregiver in static mode (PHASE A), secondaryOutcomes measure: Discomfort perceived by the caregiver in static mode (PHASE A), secondaryOutcomes measure: Discomfort perceived by the caregiver in static mode (PHASE A), secondaryOutcomes measure: Discomfort perceived by the caregiver in dynamic mode (PHASE B), secondaryOutcomes measure: Discomfort perceived by the caregiver in dynamic mode (PHASE B), secondaryOutcomes measure: Discomfort perceived by the caregiver in dynamic mode (PHASE B), secondaryOutcomes measure: Discomfort perceived by the caregiver in dynamic mode (PHASE B), secondaryOutcomes measure: Safety as perceived by the caregiver/carer in static mode (PHASE A), secondaryOutcomes measure: Safety as perceived by the caregiver/carer in static mode (PHASE A), secondaryOutcomes measure: Safety as perceived by the caregiver/carer in static mode (PHASE A), secondaryOutcomes measure: Safety as perceived by the caregiver/carer in static mode (PHASE A), secondaryOutcomes measure: Safety as perceived by the caregiver/carer in dynamic mode (PHASE B), secondaryOutcomes measure: Safety as perceived by the caregiver/carer in dynamic mode (PHASE B), secondaryOutcomes measure: Safety as perceived by the caregiver/carer in dynamic mode (PHASE B), secondaryOutcomes measure: Safety as perceived by the caregiver/carer in dynamic mode (PHASE B), secondaryOutcomes measure: Average of peak forces exerted on the wheelchair's backrest in static mode (PHASE A), secondaryOutcomes measure: Average of peak forces exerted on the wheelchair's backrest in static mode (PHASE A), secondaryOutcomes measure: Average of peak forces exerted on the wheelchair's backrest in static mode (PHASE A), secondaryOutcomes measure: Average of peak forces exerted on the wheelchair's backrest in static mode (PHASE A), secondaryOutcomes measure: Average of peak forces exerted on the wheelchair's backrest in dynamic mode (PHASE B), secondaryOutcomes measure: Average of peak forces exerted on the wheelchair's backrest in dynamic mode (PHASE B), secondaryOutcomes measure: Average of peak forces exerted on the wheelchair's backrest in dynamic mode (PHASE B), secondaryOutcomes measure: Average of peak forces exerted on the wheelchair's backrest in dynamic mode (PHASE B), secondaryOutcomes measure: Average of peak forces exerted on the wheelchair's seat in static mode (PHASE A), secondaryOutcomes measure: Average of peak forces exerted on the wheelchair's seat in static mode (PHASE A), secondaryOutcomes measure: Average of peak forces exerted on the wheelchair's seat in static mode (PHASE A), secondaryOutcomes measure: Average of peak forces exerted on the wheelchair's seat in static mode (PHASE A), secondaryOutcomes measure: Average of peak forces exerted on the wheelchair's seat in dynamic mode (PHASE B), secondaryOutcomes measure: Average of peak forces exerted on the wheelchair's seat in dynamic mode (PHASE B), secondaryOutcomes measure: Average of peak forces exerted on the wheelchair's seat in dynamic mode (PHASE B), secondaryOutcomes measure: Average of peak forces exerted on the wheelchair's seat in dynamic mode (PHASE B), otherOutcomes measure: Sex, otherOutcomes measure: Age, otherOutcomes measure: Height, otherOutcomes measure: Weight, otherOutcomes measure: Body mass index, eligibilityModule sex: ALL, minimumAge: 16 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False