An interventional study of Balance rehabilitation with modified visual input and Balance rehabilitation with no modified visual input in Neuropathy, Ataxia and Proprioceptive Disorders, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-27.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Treatment
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:
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.
149 studies on the registry are indexed under Ataxia; 37 are open to participants now.
This study's planned enrollment of 40 is above the median of 30 across 100 interventional studies indexed under Ataxia.
Browse Ataxia studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
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Exclusion Criteria:
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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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
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
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.
Patients will perform the exercises while keeping their eyes openned
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 session
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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
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
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
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
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.
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
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
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
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.
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
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
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.
Evaluate balance by the Romberg quotient collected during a static stabilometry test 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
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.
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
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
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
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
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.
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.
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.
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.
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
Evaluate sensitivity by a score of kinesthetic sensitivity in the lower limbs between 2 to 8 days
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.
Evaluate sensitivity by a score of kinesthetic sensitivity in the lower limbs between 60 to 70 days
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
Evaluate sensitivity by the Merkies palatal score in the lower limbs 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
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
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
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.
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.
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.
Time frame: Between 60 to 70 days after the 20th and last rehabilitation session.
Started Oct 2019 (actual). Primary completion is estimated for Jun 2027, 92 months after the start.
Of 53 non-industry interventional studies with no phase under Ataxia, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 34. This study's planned 92 months is above that.
Counting every sponsor, half of 55 studies reached it within 19 months; a quarter within 7 and three quarters within 33.
How these figures are worked out, and which studies are left out of them.
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