CompletedNot Applicable

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

France4 participantsStarted 2024-03-19

Plain-language 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

Who can participate

Age range

16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Forward slippage in static mode (PHASE A)

Timeframe: End of the 3-hour period on Day 7

Forward slippage in static mode (PHASE A)

Timeframe: End of the 3-hour period on Day 14

Forward slippage in static mode (PHASE A)

Timeframe: End of the 3-hour period on Day 21

Forward slippage in static mode (PHASE A)

Timeframe: End of the 3-hour period on Day 28

Forward slippage in dynamic mode (PHASE B)

Timeframe: End of the 3-hour period on Day 7

Forward slippage in dynamic mode (PHASE B)

Timeframe: End of the 3-hour period on Day 14

Forward slippage in dynamic mode (PHASE B)

Timeframe: End of the 3-hour period on Day 21

Trial details

NCT IDNCT06351189

SponsorCentre Hospitalier Universitaire de Nīmes

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-12-05

View on ClinicalTrials.gov More Hyperextension Spasms trials

Plain-language summary

Who can participate

Age range

16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Forward slippage in static mode (PHASE A)

Timeframe: End of the 3-hour period on Day 7

Forward slippage in static mode (PHASE A)

Timeframe: End of the 3-hour period on Day 14

Forward slippage in static mode (PHASE A)

Timeframe: End of the 3-hour period on Day 21

Forward slippage in static mode (PHASE A)

Timeframe: End of the 3-hour period on Day 28

Forward slippage in dynamic mode (PHASE B)

Timeframe: End of the 3-hour period on Day 7

Forward slippage in dynamic mode (PHASE B)

Timeframe: End of the 3-hour period on Day 14

Forward slippage in dynamic mode (PHASE B)

Timeframe: End of the 3-hour period on Day 21