Balance Rehabilitation With Modified Visual Input in Patients With Neuropathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Balance rehabilitation with modified visual input
Other interventionPatients 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
Other interventionPatients will perform the exercises while keeping their eyes openned
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Experimental groupExperimental treatment 1 intervention
Group B: control groupActive comparator 1 intervention
Trial outcomes
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.
Time frame
Between 2 to 8 days after the 20th and last rehabilitation sessionSecondary outcomes
1
U-turn time of realization, in seconds, realized at comfortable speed, measured with accelerometers 2 months after the end of the rehabilitation program.
Evaluate balance during walking with a U-turn with eyes open realized at comfortable speed, by the time of realization, in seconds, of the U-turn measured with accelerometers between 60 to 70 days after the 20th and last rehabilitation session.
Time frame
Between 60 to 70 days after the 20th and last rehabilitation session.2
U-turn time of realization, in seconds, realized at fast speed, measured with accelerometers just after the end of the rehabilitation program.
Evaluate balance during walking with a U-turn with eyes open realized at fast speed, by the time of realization, in seconds, of the U-turn measured with accelerometers between 2 to 8 days after the 20th and last rehabilitation session
Time frame
Between 2 to 8 days after the 20th and last rehabilitation session.3
U-turn time of realization, in seconds, realized at fast speed, measured with accelerometers 2 months after the end of the rehabilitation program.
Evaluate balance during walking with a U-turn with eyes open realized at fast speed, by the time of realization, in seconds, of the U-turn measured with accelerometers between 60 to 70 days after the 20th and last rehabilitation session.
Time frame
Between 60 to 70 days after the 20th and last rehabilitation session.4
Number of external steps of the U-turn 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 comfortable speed by the number of external steps of the U-turn measured with accelerometers between 2 to 8 days after the 20th and last rehabilitation session.
Time frame
Between 2 to 8 days after the 20th and last rehabilitation session.Sponsors and contacts
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Source ClinicalTrials.gov