NCT03881930 Balance Rehabilitation With Modified Visual Input in Patients With Neuropathy
| NCT ID | NCT03881930 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Neuropathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2019-10-01 |
| Primary Completion | 2027-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2019-10-01 with a primary completion date of 2027-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Bénédicte PANIGOT GUERIN, PT
PRINCIPAL INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT03881930 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Neuropathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03881930 currently recruiting?
Yes, NCT03881930 is actively recruiting participants. Contact the research team at benedicte.panigot@aphp.fr for enrollment information.
Where is the NCT03881930 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT03881930 clinical trial?
NCT03881930 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Bénédicte PANIGOT GUERIN, PT at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 40 participants.