Balance Rehabilitation With Modified Visual Input in Patients With Neuropathy (NCT03881930) | Clinical Trial Compass
RecruitingNot Applicable
Balance Rehabilitation With Modified Visual Input in Patients With Neuropathy
France40 participantsStarted 2019-10-01
Plain-language 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.
Who can participate
Age range
18 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:
* 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…
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
1
U-turn time of realization, in seconds, realized at a comfortable speed measured with accelerometers just after the end of the rehabilitation program
Timeframe: Between 2 to 8 days after the 20th and last rehabilitation session