Clinical trial NCT03881930: Balance Rehabilitation With Modified Visual Input in Patients With Neuropathy
Official title: Balance REhabilitation With Modified Visual Input in Patients With acQuired Chronic Demyelinating Neuropathy and PROprioceptive Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neuropathy
Ataxia
Proprioceptive Disorders
Balance; Distorted
Keywords: Peripheral neuropathy
Balance
Proprioceptive Disorders
Visual dependence
Rehabilitation
Physical Therapy
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2019-03-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: U-turn time of realization, in seconds, realized at a comfortable speed measured with accelerometers just after the end of the rehabilitation program
timeFrame: Between 2 to 8 days after the 20th and last rehabilitation session
Secondary outcomes:
measure: U-turn time of realization, in seconds, realized at comfortable speed, measured with accelerometers 2 months after the end of the rehabilitation program.
timeFrame: Between 60 to 70 days after the 20th and last rehabilitation session.
measure: U-turn time of realization, in seconds, realized at fast speed, measured with accelerometers just after the end of the rehabilitation program.
timeFrame: Between 2 to 8 days after the 20th and last rehabilitation session.
measure: U-turn time of realization, in seconds, realized at fast speed, measured with accelerometers 2 months after the end of the rehabilitation program.
timeFrame: Between 60 to 70 days after the 20th and last rehabilitation session.
measure: Number of external steps of the U-turn realized at a comfortable speed, measured with accelerometers just after the end of the rehabilitation program.
timeFrame: Between 2 to 8 days after the 20th and last rehabilitation session.
measure: 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.
timeFrame: Between 60 to 70 days after the 20th and last rehabilitation session.
measure: Number of external steps of the U-turn realized at fast speed, measured with accelerometers just after the end of the rehabilitation program.
timeFrame: Between 2 to 8 days after the 20th and last rehabilitation session.
measure: Number of external steps of the U-turn realized at fast speed, measured with accelerometers 2 months after the end of the rehabilitation program.
timeFrame: Between 60 to 70 days after the 20th and last rehabilitation session.
measure: The double stance phase time, walking 20 meters, realized at a comfortable speed, measured with accelerometers just after the end of the rehabilitation program
timeFrame: Between 2 to 8 days after the 20th and last rehabilitation session.
measure: The double stance phase, walking 20 meters, realized at a comfortable speed, measured with accelerometers 2 months after the end of the rehabilitation program.
timeFrame: Between 60 to 70 days after the 20th and last rehabilitation session.
measure: 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.
timeFrame: Between 2 to 8 days after the 20th and last rehabilitation session.
measure: The double stance phase, walking 20 meters, realized at fast speed, measured with accelerometers 2 months after the end of the rehabilitation program.
timeFrame: Between 60 to 70 days after the 20th and last rehabilitation session.
measure: 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.
timeFrame: Between 2 to 8 days after the 20th and last rehabilitation session.
measure: 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.
timeFrame: between 60 to 70 days after the 20th and last rehabilitation session.
measure: 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.
timeFrame: Between 2 to 8 days after the 20th and last rehabilitation session.
measure: 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.
timeFrame: Between 60 to 70 days after the 20th and last rehabilitation session.
measure: Time in seconds, to walk 10 meters, realized with open eyes at a comfortable speed just after the end of the rehabilitation program.
timeFrame: Between 2 to 8 days after the 20th and last rehabilitation session.
measure: Time in seconds, to walk 10 meters, realized with open eyes at a comfortable speed 2 months after the end of the rehabilitation.
timeFrame: Between 60 to 70 days after the 20th and last rehabilitation session.
measure: The number of steps, to walk 10 meters with open eyes at a comfortable speed just after the end of the rehabilitation
timeFrame: Between 2 to 8 days after the 20th and last rehabilitation session
measure: The number of steps, to walk 10 meters with open eyes at a comfortable speed 2 months after the end of the rehabilitation
timeFrame: Between 60 to 70 days after the 20th and last rehabilitation session.
measure: The Goggle Task performed just after the end of the rehabilitation program
timeFrame: Between 2 to 8 days after the 20th and last rehabilitation session
measure: The Goggle Task performed 2 months after the end of the rehabilitation
timeFrame: Between 60 to 70 days after the 20th and last rehabilitation session.
measure: The times, in seconds, of descent and ascent of a staircase floor, realized just after the end of the rehabilitation program
timeFrame: Between 2 to 8 days after the 20th and last rehabilitation session.
measure: The times, in seconds, of descent and ascent of a staircase floor, realized 2 months after the end of the rehabilitation
timeFrame: Between 60 to 70 days after the 20th and last rehabilitation session.
measure: Romberg quotient collected just after the end of the rehabilitation program.
timeFrame: Between 2 to 8 days after the 20th and last rehabilitation session
measure: Romberg quotient collected 2 months after the end of the rehabilitation
timeFrame: Between 60 to 70 days after the 20th and last rehabilitation session.
measure: Sensory preference realized just after the end of the rehabilitation program
timeFrame: Between 2 to 8 days after the 20th and last rehabilitation session
measure: Sensory preference realized 2 months after from the end of the rehabilitation
timeFrame: between 60 to 70 days after the 20th and last rehabilitation session
measure: Monofilament test 10 g just after the end of the rehabilitation program.
timeFrame: Between 2 to 8 days after the 20th and last rehabilitation session.
measure: Monofilament test 10 g, 2 months after the end of the rehabilitation.
timeFrame: Between 60 to 70 days after the 20th and last rehabilitation session.
measure: Score of kinesthetic sensitivity in the lower limbs just after the end of the rehabilitation program
timeFrame: Between 2 to 8 days after the 20th and last rehabilitation session
measure: Score of kinesthetic sensitivity in the lower limbs, 2 months after the end of the rehabilitation.
timeFrame: Between 60 to 70 days after the 20th and last rehabilitation session.
measure: Merkies palatal score in the lower limbs just after the end of the rehabilitation program
timeFrame: Between 2 to 8 days after the 20th and last rehabilitation session
measure: Merkies palatal score in the lower limbs 2 months after the end of the rehabilitation
timeFrame: Between 60 to 70 days after the 20th and last rehabilitation session.
measure: Simplified version of the "Activities-specific Balance Confidence scale just after the end of the rehabilitation program
timeFrame: Between 2 to 8 days after the 20th and last rehabilitation session.
measure: Simplified version of the "Activities-specific Balance Confidence scale 2 months after the end of the rehabilitation.
timeFrame: Between 60 to 70 days after the 20th and last rehabilitation session.
Other outcomes:
Locations:
city: Paris
country: France
facility: Service de Médecine Physique et de Réadaptation (MPR)
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Bénédicte PANIGOT GUERIN, PT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.