Balance Rehabilitation With Modified Visual Input in Patients With Neuropathy

NCT03881930 · tracked via the Priya Life Science France tracker

Sponsor

Assistance Publique - Hôpitaux de Paris

Phase

Not applicable

Started

2019-10-01

Last updated

2026-05-27

Condition(s) studied

NeuropathyAtaxiaProprioceptive DisordersBalance; Distorted

Investigational drug(s) / intervention(s)

Balance rehabilitation with modified visual inputBalance rehabilitation with no modified visual input

Balance rehabilitation with modified visual input: Patients will perform the exercises alternatively: while keeping their eyes closed or their vision will be obstructed by a opaque mask or disturbed by moving luminous dots projected on the environment in a dark room without any visual reference cues.

Balance rehabilitation with no modified visual input: Patients will perform the exercises while keeping their eyes openned

Study summary

This research focuses on the effects of rehabilitation on balance, in patients with acquired chronic demyelinating neuropathy. Rehabilitation will be performed with or without vision.

It is planned to include 40 subjects consulting for walking instability related to sensitivity disorders.

This multicenter study will take place in Paris's area. Each participant will benefit from 20 rehabilitation sessions with a Physical Therapist and 3 assessments.

Thanks to randomization, patient will be allocated in one of the 2 following groups:

* Control group, Patients will benefit from balance rehabilitation with open eyes.
* Experimental group, they will perform the same exercises while keeping their eyes closed or their vision will be obstructed by a mask or disturbed by moving luminous dots projected on the environment in darkness.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Patients with chronic demyelinating acquired neuropathy * Age ≥ 18 years. * Patients able to walk 20 meters without human assistance at least indoors with or without technical assistance. * Patients with complaints such as discomfort, walking instability related to sensitivity disorders. * Patients being clinically stable for at least 2 months, regardless of ongoing treatments. * Patients who have provided consent. Exclusion Criteria: * Patients unable to walk 20 metres without technical and human assistance indoors. * Patients with an ongoing hospitalization. * Patients already included and participating in another intervention study. * Patients with ongoing balance rehabilitation and continued during the REQ-PRO program in another rehabilitation centre or practice. * Patients with ongoing acute treatment (related to polyneuropathy) started less than 2 months ago or stopped less than 2 months ago. * Patients with scheduled surgery during the period of the patient's participation in the protocol, preventing the successful completion of the rehabilitation program and participation in assessments. * Patients with recent surgery, in particular lower limb prosthesis (less than 1 year old) or equipment contraindicated for planned exercises such as standing kneeling positions. * Patients with skin wounds on the foot that contraindicate rehabilitation. * Patients with balance disorders of vestibular origin or central neurological pathology. * Patients with a visual disability. * Patients with a hearing impairment that prevents the patient from hearing and understanding instructions during the rehabilitation program or assessments. * Patients with an inability to speak or understand the French language. * Patients with cognitive or language impairments that prevent understanding of the protocol. * Patients with a residence outside of the Paris Region (Ile de France). * Patients with a known pregnancy. * Patients not affiliated to a social security system (beneficiary or having a right), deprived of their right, under guardianship, curatorship, prisoner.

Primary outcome measure(s)

U-turn time of realization, in seconds, realized at a comfortable speed measured with accelerometers just after the end of the rehabilitation program — Between 2 to 8 days after the 20th and last rehabilitation session
Evaluate balance during walking with a U-turn realized with eyes open at a comfortable speed by the time of realization, in seconds, of the U-turn, measured with accelerometers between 2 to 8 days after 20th and last rehabilitation session.

Trial sites (1)

Facility	City	Region	Status
Service de Médecine Physique et de Réadaptation (MPR)	Paris	France	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03881930 on ClinicalTrials.gov ↗ ← All trials in France