NeuropathyREQ-PRONCT03881930
Balance Rehabilitation With Modified Visual Input in Patients With Neuropathy
A study testing Balance rehabilitation with modified visual input and Balance rehabilitation with no modified visual input in people with Neuropathy and Ataxia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathy, Ataxia, Proprioceptive Disorders
- What is being tested?
- Balance rehabilitation with modified visual input and Balance rehabilitation with no modified visual input
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2019to 1 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de Médecine Physique et de Réadaptation (MPR)
Paris, 75010
Bénédicte PANIGOT GUERIN, 01.40.05.41.73, benedicte.panigot@aphp.fr
About this study
Official title: Balance REhabilitation With Modified Visual Input in Patients With acQuired Chronic Demyelinating Neuropathy and PROprioceptive Disorders
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.
Read more
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.
Read the detailed description
Patients with chronic acquired demyelinating neuropathy may be referred for instability or falls when walking. Some of them have complaints of dysesthesia, paresthesia. The majority of these patients, due to the involvement of large sensory fibres, have deep and superficial sensitivity disorders (hypoesthesia or anaesthesia), which explain proprioceptive ataxia and balance disorders.
In a given situation, an individual maintains his or her balance thanks to sensory information, among which he or she may have to choose the most appropriate one for the context. A good balance control depends on the ability to select the best information, but many subjects do not have, or have lost, this ability, giving too systematically priority to the same sensory input. This is what is called sensory preferences or sensory profiles that differ from one subject to another. The most common behaviour is visual dependence.
This tendency to visual dependence has been described in different pathological situations, especially after a stroke. Research has shown that specific rehabilitation in visual deprivation can reduce visual dependence and improve balance and walking autonomy in stroke patients.
The investigators have shown in previous work that patients with acquired chronic demyelinating neuropathy have ataxic symptomatology with a visual dependence behavior, while a good sensitivity to vibration stimulation of proprioceptive pathways persists. The proprioceptive potential still present seems to be under-used.
Rehabilitation of patients with peripheral neuropathy involves many techniques, such as muscle strengthening, vibration, virtual reality, Tai chi, electrical stimulation, etc. However, some techniques, such as the use of virtual reality or visual biofeedback, tend to increase the use of the visual input, which could be detrimental to other inputs. The specific approach to balance disorders in these patients through manipulation of the visual input has, to our knowledge, not been studied. This is the objective of the study.
The main hypothesis of this research is that rehabilitation with modified visual input can, by reducing visual dependence, strengthen the proprioceptive input that still appears to be available in these patients with acquired chronic demyelinating neuropathy, despite deficits already present, and thus improve balance and walking ability.
- Conditions
- Neuropathy, Ataxia, Proprioceptive Disorders, Balance; Distorted
- Being tested
- Balance rehabilitation with modified visual input, Balance rehabilitation with no modified visual input
- Keywords
- Peripheral neuropathy, Balance, Proprioceptive Disorders, Visual dependence, Rehabilitation, Physical Therapy
- Medical subject headings
- Ataxia, Somatosensory Disorders, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance rehabilitation with modified visual inputOther
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 inputOther
Patients will perform the exercises while keeping their eyes openned
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Balance rehabilitation with no modified visual input |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
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
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
Evaluate balance during walking with a U-turn realized with eyes open at a comfortable speed by the number of external steps of the U-turn measured with accelerometers between 60 to 70 days after the 20th and last rehabilitation session.
Measured: Between 60 to 70 days after the 20th and last rehabilitation session.
Number of external steps of the U-turn realized at fast 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 fast 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.
Measured: Between 2 to 8 days after the 20th and last rehabilitation session.
Number of external steps of the U-turn realized at fast speed, measured with accelerometers 2 months after the end of the rehabilitation program.
Evaluate balance during walking with a U-turn realized with eyes open at fast speed by the number of external steps of the U-turn measured with accelerometers between 60 to 70 days after the 20th and last rehabilitation session.
Measured: Between 60 to 70 days after the 20th and last rehabilitation session.
The double stance phase time, walking 20 meters, 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 double stance phase in %, to walk 20 meters, measured with accelerometers between 2 to 8 days after the 20th and last rehabilitation session.
Measured: Between 2 to 8 days after the 20th and last rehabilitation session.
The double stance phase, walking 20 meters, realized at a comfortable speed, measured with accelerometers 2 months 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 double stance phase in %, to walk 20 meters, measured with accelerometers between 60 to 70 days after the 20th and last rehabilitation session.
Measured: Between 60 to 70 days after the 20th and last rehabilitation session.
The double stance phase, walking 20 meters during walking with a U-turn, realized at fast 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 fast speed by the double stance phase in %, to walk 20 meters, measured with accelerometers between 2 to 8 days after the 20th and last rehabilitation session.
Measured: Between 2 to 8 days after the 20th and last rehabilitation session.
The double stance phase, walking 20 meters, realized at fast speed, measured with accelerometers 2 months after the end of the rehabilitation program.
Evaluate balance during walking with a U-turn realized with eyes open at fast speed by the double stance phase in %, to walk 20 meters, measured with accelerometers between 60 to 70 days after the 20th and last rehabilitation session.
Measured: Between 60 to 70 days after the 20th and last rehabilitation session.
Global amount of movement during walking with a 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 global amount of movement (related to oscillations and abruptness of the gesture) measured with accelerometers between 2 to 8 days after the 20th and last rehabilitation session.
Measured: Between 2 to 8 days after the 20th and last rehabilitation session.
Global amount of movement during walking with a U-turn, realized at a comfortable speed, measured with accelerometers 2 months after the end of the rehabilitation program.
Evaluate balance during walking with a U-turn realized with eyes open at a comfortable speed by global amount of movement (related to oscillations and abruptness of the gesture), measured with accelerometers between 60 to 70 days after the 20th and last rehabilitation session.
Measured: between 60 to 70 days after the 20th and last rehabilitation session.
Global amount of movement during walking with a U-turn realized at fast 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 fast speed by the global amount of movement (related to oscillations and abruptness of the gesture), measured with accelerometers between 2 to 8 days after the 20th and last rehabilitation session.
Measured: Between 2 to 8 days after the 20th and last rehabilitation session.
Global amount of movement during walking with a U-turn realized at fast speed, measured with accelerometers 2 months after the end of the rehabilitation program.
Evaluate balance during walking with a U-turn realized with eyes open at fast speed by global amount of movement (related to oscillations and abruptness of the gesture), measured with accelerometers between 60 to 70 days after the 20th and last rehabilitation session.
Measured: Between 60 to 70 days after the 20th and last rehabilitation session.
Time in seconds, to walk 10 meters, realized with open eyes at a comfortable speed just after the end of the rehabilitation program.
Evaluate the balance by the Time in seconds, to walk 10 meters, realized with open eyes at a comfortable speed between 2 to 8 days after the 20th and last rehabilitation session.
Measured: Between 2 to 8 days after the 20th and last rehabilitation session.
Time in seconds, to walk 10 meters, realized with open eyes at a comfortable speed 2 months after the end of the rehabilitation.
Evaluate the balance by the Time in seconds, to walk 10 meters, realized with open eyes at a comfortable speed between 60 to 70 days after the 20th and last rehabilitation session.
Measured: Between 60 to 70 days after the 20th and last rehabilitation session.
The number of steps, to walk 10 meters with open eyes at a comfortable speed just after the end of the rehabilitation
Evaluate the balance by the the number of steps, to walk 10 meters with open eyes at a comfortable speed between 2 to 8 days after the 20th and last rehabilitation session
Measured: Between 2 to 8 days after the 20th and last rehabilitation session
The number of steps, to walk 10 meters with open eyes at a comfortable speed 2 months after the end of the rehabilitation
Evaluate the balance by the the number of steps, to walk 10 meters with open eyes at a comfortable speed between 60 to 70 days after the 20th and last rehabilitation session
Measured: Between 60 to 70 days after the 20th and last rehabilitation session.
The Goggle Task performed just after the end of the rehabilitation program
Evaluate the balance by the Goggle Task, the ratio: time in seconds, to walk 10 meters, in visual deprivation at comfortable speed / time in seconds, to walk 10 meters, eyes open at comfortable speed just after the end of the rehabilitation program.
Measured: Between 2 to 8 days after the 20th and last rehabilitation session
The Goggle Task performed 2 months after the end of the rehabilitation
Evaluate the balance by the Goggle Task, the ratio: time in seconds, to walk 10 meters, in visual deprivation at comfortable speed / time in seconds, to walk 10 meters, eyes open at comfortable speed between 60 to 70 days after the 20th and last rehabilitation session
Measured: Between 60 to 70 days after the 20th and last rehabilitation session.
The times, in seconds, of descent and ascent of a staircase floor, realized just after the end of the rehabilitation program
Evaluate balance by the times, in seconds, of descent and ascent of a staircase floor, realized with open eyes between 2 to 8 days after the 20th and last rehabilitation session.
Measured: Between 2 to 8 days after the 20th and last rehabilitation session.
The times, in seconds, of descent and ascent of a staircase floor, realized 2 months after the end of the rehabilitation
Evaluate balance by the times, in seconds, of descent and ascent of a staircase floor, realized with open eyes between 60 to 70 days after the 20th and last rehabilitation session
Measured: Between 60 to 70 days after the 20th and last rehabilitation session.
Romberg quotient collected just after the end of the rehabilitation program.
Evaluate balance by the Romberg quotient collected during a static stabilometry test between 2 to 8 days after the 20th and last rehabilitation session.
Measured: Between 2 to 8 days after the 20th and last rehabilitation session
Romberg quotient collected 2 months after the end of the rehabilitation
Evaluate balance by the Romberg quotient collected during a static stabilometry test between 60 to 70 days after the 20th and last rehabilitation session.
Measured: Between 60 to 70 days after the 20th and last rehabilitation session.
Sensory preference realized just after the end of the rehabilitation program
Determine the sensory profile of the patient by the sensory preference score after visual and proprioceptive stimuli between 2 to 8 days after the 20th and last rehabilitation session
Measured: Between 2 to 8 days after the 20th and last rehabilitation session
Sensory preference realized 2 months after from the end of the rehabilitation
Determine the sensory profile of the patient by the sensory preference score after visual and proprioceptive stimuli between 60 to 70 days after the 20th and last rehabilitation session
Measured: between 60 to 70 days after the 20th and last rehabilitation session
Monofilament test 10 g just after the end of the rehabilitation program.
Evaluate the superficial sensitivity to tact on the sole of the foot by the monofilament test 10 g (Semmes-Weinstein 5.07) between 2 to 8 days after the 20th and last rehabilitation session.
Measured: Between 2 to 8 days after the 20th and last rehabilitation session.
Monofilament test 10 g, 2 months after the end of the rehabilitation.
Evaluate the superficial sensitivity to tact on the sole of the foot by the monofilament test 10 g (Semmes-Weinstein 5.07) between 60 to 70 days after the 20th and last rehabilitation session.
Measured: Between 60 to 70 days after the 20th and last rehabilitation session.
Score of kinesthetic sensitivity in the lower limbs just after the end of the rehabilitation program
Evaluate sensitivity by a score of kinesthetic sensitivity in the lower limbs between 2 to 8 days
Measured: Between 2 to 8 days after the 20th and last rehabilitation session
Score of kinesthetic sensitivity in the lower limbs, 2 months after the end of the rehabilitation.
Evaluate sensitivity by a score of kinesthetic sensitivity in the lower limbs between 60 to 70 days
Measured: Between 60 to 70 days after the 20th and last rehabilitation session.
Merkies palatal score in the lower limbs just after the end of the rehabilitation program
Evaluate sensitivity by the Merkies palatal score in the lower limbs between 2 to 8 days after the 20th and last rehabilitation session.
Measured: Between 2 to 8 days after the 20th and last rehabilitation session
Merkies palatal score in the lower limbs 2 months after the end of the rehabilitation
Evaluate sensitivity by the Merkies palatal score in the lower limbs between 60 to 70 days after the 20th and last rehabilitation session
Measured: Between 60 to 70 days after the 20th and last rehabilitation session.
Simplified version of the "Activities-specific Balance Confidence scale just after the end of the rehabilitation program
Evaluate the person's confidence in his or her balance, in the activities of daily living Simplified version of the "Activities-specific Balance Confidence scale between 2 to 8 days:the 20th and last rehabilitation session.
Questionnaire made of 15 statements to assess the person's degree of confidence in his or her balance associated with activities of daily life in both the home environment and in the community environment. The questionnaire is part of this research administered by the evaluator.
Add the scores obtained to the 15 items to obtain an overall score out of 45. The score is converted to a pourcentage.
Measured: Between 2 to 8 days after the 20th and last rehabilitation session.
Simplified version of the "Activities-specific Balance Confidence scale 2 months after the end of the rehabilitation.
Evaluate the person's confidence in his or her balance, in the activities of daily living Simplified version of the "Activities-specific Balance Confidence scale between ¬60 to 70 days: the 20th and last rehabilitation session.
Questionnaire made of 15 statements to assess the person's degree of confidence in his or her balance associated with activities of daily life in both the home environment and in the community environment. The questionnaire is part of this research administered by the evaluator.
Add the scores obtained to the 15 items to obtain an overall score out of 45. The score is converted to a pourcentage.
Measured: Between 60 to 70 days after the 20th and last rehabilitation session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start1 Oct 2019
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for NeuropathyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bénédicte PANIGOT GUERIN, PT, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03881930
- Sponsor's protocol ID
- K170911J
- Acronym
- REQ-PRO
- Status last verified
- May 2026
- First submitted
- 25 Jan 2019
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28555124Bonan 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.
PubMed 14966713Yelnik 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.
PubMed 18780882Provost 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.
PubMed 29313871Missaoui 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.
PubMed 23465318Filiatrault 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.
PubMed 17466738
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balance REhabilitation With Modified Visual Input in Patients With acQuired Chronic Demyelinating Neuropathy and PROprioceptive Disorders
- ClinicalTrials.gov ID
- NCT03881930
- Acronym / sponsor ID
- REQ-PRO / K170911J
- Conditions
- Neuropathy, Ataxia, Proprioceptive Disorders, Balance; Distorted
- Keywords
- Peripheral neuropathy, Balance, Proprioceptive Disorders, Visual dependence, Rehabilitation, Physical Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 20 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients with chronic acquired demyelinating neuropathy may be referred for instability or falls when walking. Some of them have complaints of dysesthesia, paresthesia. The majority of these patients, due to the involvement of large sensory fibres, have deep and superficial sensitivity disorders (hypoesthesia or anaesthesia), which explain proprioceptive ataxia and balance disorders.
In a given situation, an individual maintains his or her balance thanks to sensory information, among which he or she may have to choose the most appropriate one for the context. A good balance control depends on the ability to select the best information, but many subjects do not have, or have lost, this ability, giving too systematically priority to the same sensory input. This is what is called sensory preferences or sensory profiles that differ from one subject to another. The most common behaviour is visual dependence.
This tendency to visual dependence has been described in different pathological situations, especially after a stroke. Research has shown that specific rehabilitation in visual deprivation can reduce visual dependence and improve balance and walking autonomy in stroke patients.
The investigators have shown in previous work that patients with acquired chronic demyelinating neuropathy have ataxic symptomatology with a visual dependence behavior, while a good sensitivity to vibration stimulation of proprioceptive pathways persists. The proprioceptive potential still present seems to be under-used.
Rehabilitation of patients with peripheral neuropathy involves many techniques, such as muscle strengthening, vibration, virtual reality, Tai chi, electrical stimulation, etc. However, some techniques, such as the use of virtual reality or visual biofeedback, tend to increase the use of the visual input, which could be detrimental to other inputs. The specific approach to balance disorders in these patients through manipulation of the visual input has, to our knowledge, not been studied. This is the objective of the study.
The main hypothesis of this research is that rehabilitation with modified visual input can, by reducing visual dependence, strengthen the proprioceptive input that still appears to be available in these patients with acquired chronic demyelinating neuropathy, despite deficits already present, and thus improve balance and walking ability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Balance rehabilitation with modified visual inputBalance 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. |
| control group | Active comparator | Other: Balance rehabilitation with no modified visual inputBalance 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balance rehabilitation with modified visual inputPatients 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. | Other | Experimental group |
| Balance rehabilitation with no modified visual inputPatients will perform the exercises while keeping their eyes openned | Other | control group |
Primary outcome
U-turn time of realization, in seconds, realized at a comfortable speed measured with accelerometers just after the end of the rehabilitation program
Time frame: 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.
35 secondary outcomes
U-turn time of realization, in seconds, realized at comfortable speed, measured with accelerometers 2 months after the end of the rehabilitation program.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Between 60 to 70 days after the 20th and last rehabilitation session.
Number of external steps of the U-turn realized at fast speed, measured with accelerometers just after the end of the rehabilitation program.
Time frame: Between 2 to 8 days after the 20th and last rehabilitation session.
Number of external steps of the U-turn realized at fast speed, measured with accelerometers 2 months after the end of the rehabilitation program.
Time frame: Between 60 to 70 days after the 20th and last rehabilitation session.
The double stance phase time, walking 20 meters, realized at a comfortable speed, measured with accelerometers just after the end of the rehabilitation program
Time frame: Between 2 to 8 days after the 20th and last rehabilitation session.
The double stance phase, walking 20 meters, realized at a comfortable speed, measured with accelerometers 2 months after the end of the rehabilitation program.
Time frame: Between 60 to 70 days after the 20th and last rehabilitation session.
The double stance phase, walking 20 meters during walking with a U-turn, realized at fast speed, measured with accelerometers just after the end of the rehabilitation program.
Time frame: Between 2 to 8 days after the 20th and last rehabilitation session.
The double stance phase, walking 20 meters, realized at fast speed, measured with accelerometers 2 months after the end of the rehabilitation program.
Time frame: Between 60 to 70 days after the 20th and last rehabilitation session.
Global amount of movement during walking with a U-turn realized at a comfortable speed, measured with accelerometers just after the end of the rehabilitation program.
Time frame: Between 2 to 8 days after the 20th and last rehabilitation session.
Global amount of movement during walking with a U-turn, realized at a comfortable speed, measured with accelerometers 2 months after the end of the rehabilitation program.
Time frame: between 60 to 70 days after the 20th and last rehabilitation session.
Global amount of movement during walking with a U-turn realized at fast speed, measured with accelerometers just after the end of the rehabilitation program.
Time frame: Between 2 to 8 days after the 20th and last rehabilitation session.
Global amount of movement during walking with a U-turn realized at fast speed, measured with accelerometers 2 months after the end of the rehabilitation program.
Time frame: Between 60 to 70 days after the 20th and last rehabilitation session.
Time in seconds, to walk 10 meters, realized with open eyes at a comfortable speed just after the end of the rehabilitation program.
Time frame: Between 2 to 8 days after the 20th and last rehabilitation session.
Time in seconds, to walk 10 meters, realized with open eyes at a comfortable speed 2 months after the end of the rehabilitation.
Time frame: Between 60 to 70 days after the 20th and last rehabilitation session.
The number of steps, to walk 10 meters with open eyes at a comfortable speed just after the end of the rehabilitation
Time frame: Between 2 to 8 days after the 20th and last rehabilitation session
The number of steps, to walk 10 meters with open eyes at a comfortable speed 2 months after the end of the rehabilitation
Time frame: Between 60 to 70 days after the 20th and last rehabilitation session.
The Goggle Task performed just after the end of the rehabilitation program
Time frame: Between 2 to 8 days after the 20th and last rehabilitation session
The Goggle Task performed 2 months after the end of the rehabilitation
Time frame: Between 60 to 70 days after the 20th and last rehabilitation session.
The times, in seconds, of descent and ascent of a staircase floor, realized just after the end of the rehabilitation program
Time frame: Between 2 to 8 days after the 20th and last rehabilitation session.
The times, in seconds, of descent and ascent of a staircase floor, realized 2 months after the end of the rehabilitation
Time frame: Between 60 to 70 days after the 20th and last rehabilitation session.
Romberg quotient collected just after the end of the rehabilitation program.
Time frame: Between 2 to 8 days after the 20th and last rehabilitation session
Romberg quotient collected 2 months after the end of the rehabilitation
Time frame: Between 60 to 70 days after the 20th and last rehabilitation session.
Sensory preference realized just after the end of the rehabilitation program
Time frame: Between 2 to 8 days after the 20th and last rehabilitation session
Sensory preference realized 2 months after from the end of the rehabilitation
Time frame: between 60 to 70 days after the 20th and last rehabilitation session
Monofilament test 10 g just after the end of the rehabilitation program.
Time frame: Between 2 to 8 days after the 20th and last rehabilitation session.
Monofilament test 10 g, 2 months after the end of the rehabilitation.
Time frame: Between 60 to 70 days after the 20th and last rehabilitation session.
Score of kinesthetic sensitivity in the lower limbs just after the end of the rehabilitation program
Time frame: Between 2 to 8 days after the 20th and last rehabilitation session
Score of kinesthetic sensitivity in the lower limbs, 2 months after the end of the rehabilitation.
Time frame: Between 60 to 70 days after the 20th and last rehabilitation session.
Merkies palatal score in the lower limbs just after the end of the rehabilitation program
Time frame: Between 2 to 8 days after the 20th and last rehabilitation session
Merkies palatal score in the lower limbs 2 months after the end of the rehabilitation
Time frame: Between 60 to 70 days after the 20th and last rehabilitation session.
Simplified version of the "Activities-specific Balance Confidence scale just after the end of the rehabilitation program
Time frame: Between 2 to 8 days after the 20th and last rehabilitation session.
Simplified version of the "Activities-specific Balance Confidence scale 2 months after the end of the rehabilitation.
Time frame: Between 60 to 70 days after the 20th and last rehabilitation session.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Background: PubMed 28555124Barrois 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.
- Background: PubMed 14966713Bonan 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.
- Background: PubMed 18780882Yelnik 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.
- Background: PubMed 29313871Provost 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.
- Background: PubMed 23465318Missaoui 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.
- Background: PubMed 17466738Filiatrault 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.
- Related InfoLink provided by the sponsor.
Related trials for Neuropathy
RecruitingObservational study
Natural History Evaluation of Charcot Marie Tooth Disease (CMT) Types CMT1B, CMT2A, CMT4A, CMT4C, and Others
Charcot Marie Tooth Disease
Recruiting
Acupuncture and Exercise for EV-Pembro-Induced Peripheral Neuropathy
Metastatic Bladder Cancer, Peripheral Neuropathy
Not yet recruitingObservational study
Muscle MRI Fat Fraction Before Surgery to Predict Strength Recovery After Foot-Drop Surgery in Charcot-Marie-Tooth Disease
Foot Drop, Charcot-Marie-Tooth Disease Type 1A
RecruitingObservational study
Establishing Normative Data for Pupillometer Assessments in Neuro-Intensive Care
Critical Illness, Neuropathy
Active, not recruiting
Functional and Neuroprotective Effects of Restoring Lower Limb Sensation After Diabetic Peripheral Neuropathy
Lower Extremity Amputee, Diabetic Peripheral Neuropathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bénédicte PANIGOT GUERIN, PT principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance rehabilitation with modified visual input and Balance rehabilitation with no modified visual input in people with Neuropathy and Ataxia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bénédicte PANIGOT GUERIN, PT (01.40.05.41.73, benedicte.panigot@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
U-turn time of realization, in seconds, realized at a comfortable speed measured with accelerometers just after the end of the rehabilitation program (time frame: Between 2 to 8 days after the 20th and last rehabilitation session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03881930, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.