Balance Rehabilitation With Modified Visual Input in Patients With Neuropathy

NCT03881930 | Recruiting

• 1 other identifier: K170911J
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuropathy; Ataxia; Proprioceptive Disorders; Balance; Distorted

Keywords

Peripheral neuropathy; Balance; Proprioceptive Disorders; Visual dependence; Rehabilitation; Physical Therapy

Outcome Measures

Primary Outcomes (1)

• U-turn time of realization, in seconds, realized at a comfortable speed measured with accelerometers just after the end of the rehabilitation program

  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.

  Between 2 to 8 days after the 20th and last rehabilitation session

Secondary Outcomes (35)

• U-turn time of realization, in seconds, realized at comfortable speed, measured with accelerometers 2 months after the end of the rehabilitation program.

  Between 60 to 70 days after the 20th and last rehabilitation session.

• U-turn time of realization, in seconds, realized at fast speed, measured with accelerometers just after the end of the rehabilitation program.

  Between 2 to 8 days after the 20th and last rehabilitation session.

• U-turn time of realization, in seconds, realized at fast speed, measured with accelerometers 2 months after the end of the rehabilitation program.

  Between 60 to 70 days after the 20th and last rehabilitation session.

• Number of external steps of the U-turn 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.

• Number of external steps of the U-turn realized at a comfortable speed, measured with accelerometers 2 months after the end of the rehabilitation program.

  Between 60 to 70 days after the 20th and last rehabilitation session.

Study Arms (2)

Experimental group

EXPERIMENTAL

Balance rehabilitation with modified visual input: In experimental group, patients with chronic acquired demyelinating neuropathy will benefit from 20 rehabilitation sessions with a Physical Therapist and 3 assessments. They will perform balance training with modified visual input.

Other: Balance rehabilitation with modified visual input

control group

ACTIVE COMPARATOR

Balance rehabilitation with no modified visual input: In control group, patients with chronic acquired demyelinating neuropathy will benefit from 20 rehabilitation sessions with a Physical Therapist and 3 assessments. They will perform balance training with no modified visual input.

Other: Balance rehabilitation with no modified visual input

Interventions

Balance rehabilitation with modified visual input OTHER

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.

Experimental group

Balance rehabilitation with no modified visual input OTHER

Patients will perform the exercises while keeping their eyes openned

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service de Médecine Physique et de Réadaptation (MPR)

Paris, 75010, France

RECRUITING

Related Publications (6)

• Barrois RP, Ricard D, Oudre L, Tlili L, Provost C, Vienne A, Vidal PP, Buffat S, Yelnik AP. Observational Study of 180 degrees Turning Strategies Using Inertial Measurement Units and Fall Risk in Poststroke Hemiparetic Patients. Front Neurol. 2017 May 15;8:194. doi: 10.3389/fneur.2017.00194. eCollection 2017.

  PMID: 28555124 BACKGROUND

• Bonan IV, Yelnik AP, Colle FM, Michaud C, Normand E, Panigot B, Roth P, Guichard JP, Vicaut E. Reliance on visual information after stroke. Part II: Effectiveness of a balance rehabilitation program with visual cue deprivation after stroke: a randomized controlled trial. Arch Phys Med Rehabil. 2004 Feb;85(2):274-8. doi: 10.1016/j.apmr.2003.06.016.

  PMID: 14966713 BACKGROUND

• Yelnik AP, Le Breton F, Colle FM, Bonan IV, Hugeron C, Egal V, Lebomin E, Regnaux JP, Perennou D, Vicaut E. Rehabilitation of balance after stroke with multisensorial training: a single-blind randomized controlled study. Neurorehabil Neural Repair. 2008 Sep-Oct;22(5):468-76. doi: 10.1177/1545968308315996.

  PMID: 18780882 BACKGROUND

• Provost CP, Tasseel-Ponche S, Lozeron P, Piccinini G, Quintaine V, Arnulf B, Kubis N, Yelnik AP. Standing postural reaction to visual and proprioceptive stimulation in chronic acquired demyelinating polyneuropathy. J Rehabil Med. 2018 Feb 28;50(3):278-284. doi: 10.2340/16501977-2314.

  PMID: 29313871 BACKGROUND

• Missaoui B, Thoumie P. Balance training in ataxic neuropathies. Effects on balance and gait parameters. Gait Posture. 2013 Jul;38(3):471-6. doi: 10.1016/j.gaitpost.2013.01.017. Epub 2013 Mar 5.

  PMID: 23465318 BACKGROUND

• Filiatrault J, Gauvin L, Fournier M, Parisien M, Robitaille Y, Laforest S, Corriveau H, Richard L. Evidence of the psychometric qualities of a simplified version of the Activities-specific Balance Confidence scale for community-dwelling seniors. Arch Phys Med Rehabil. 2007 May;88(5):664-72. doi: 10.1016/j.apmr.2007.02.003.

  PMID: 17466738 BACKGROUND

MeSH Terms

Conditions

Ataxia; Somatosensory Disorders; Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sensation Disorders; Neuromuscular Diseases

Study Officials

• Bénédicte PANIGOT GUERIN, PT

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bénédicte PANIGOT GUERIN, PT

CONTACT

01.40.05.41.73; benedicte.panigot@aphp.fr

Alain YELNIK, MD, PhD

CONTACT

01.40.05.42.05; alain.yelnik@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Evaluations are carried out outside the rehabilitation programme, by blind evaluators.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Observe in patients with chronic acquired demyelinating neuropathy, the effects on balance of a rehabilitation with modified visual input (deceived visual input, or visual deprivation); compared to an identical rehabilitation of balance performed with the non-modified visual input.

Study Record Dates

• First Submitted: January 25, 2019
• First Posted: March 20, 2019
• Study Start: October 1, 2019
• Primary Completion: November 1, 2025
• Study Completion: March 1, 2026
• Last Updated: July 3, 2024

Record last verified: 2024-07

Locations

FR (1)