Balance REhabilitation With Modified Visual Input in Patients With acQuired Chronic Demyelinating Neuropathy and PROprioceptive Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- U-turn time of realization, in seconds, realized at a comfortable speed measured with accelerometers just after the end of the rehabilitation program
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Evaluations are carried out outside the rehabilitation programme, by blind evaluators.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Experimental group
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.
干预措施: Balance rehabilitation with modified visual input (Other)
control group
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.
干预措施: Balance rehabilitation with no modified visual input (Other)
结局指标
主要结局
U-turn time of realization, in seconds, realized at a comfortable speed measured with accelerometers just after the end of the rehabilitation program
时间窗: 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.
次要结局
- Sensory preference realized 2 months after from the end of the rehabilitation(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 2 months after the end of the rehabilitation program.(Between 60 to 70 days after the 20th and last rehabilitation session.)
- Number of external steps of the U-turn realized at a comfortable speed, measured with accelerometers just after the end of the rehabilitation program.(Between 2 to 8 days after the 20th and last rehabilitation session.)
- Number of external steps of the U-turn realized at fast speed, measured with accelerometers 2 months after the end of the rehabilitation program.(Between 60 to 70 days after the 20th and last rehabilitation session.)
- 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.(Between 2 to 8 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.(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.(Between 60 to 70 days after the 20th and last rehabilitation session.)
- U-turn time of realization, in seconds, realized at fast speed, measured with accelerometers just after the end of the rehabilitation program.(Between 2 to 8 days after the 20th and last rehabilitation session.)
- U-turn time of realization, in seconds, realized at fast speed, measured with accelerometers 2 months after the end of the rehabilitation program.(Between 60 to 70 days after the 20th and last rehabilitation session.)
- Number of external steps of the U-turn realized at a comfortable speed, measured with accelerometers 2 months after the end of the rehabilitation program.(Between 60 to 70 days after the 20th and last rehabilitation session.)
- Number of external steps of the U-turn realized at fast speed, measured with accelerometers just after the end of the rehabilitation program.(Between 2 to 8 days after the 20th and last rehabilitation session.)
- The double stance phase time, walking 20 meters, realized at a comfortable speed, measured with accelerometers just after the end of the rehabilitation program(Between 2 to 8 days after the 20th and last rehabilitation session.)
- The double stance phase, walking 20 meters, realized at a comfortable speed, measured with accelerometers 2 months after the end of the rehabilitation program.(Between 60 to 70 days after the 20th and last rehabilitation session.)
- 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.(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.(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.(Between 60 to 70 days after the 20th and last rehabilitation session.)
- The Goggle Task performed 2 months after the end of the rehabilitation(Between 60 to 70 days after the 20th and last rehabilitation session.)
- Sensory preference realized just after the end of the rehabilitation program(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.(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.(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(Between 60 to 70 days after the 20th and last rehabilitation session.)
- The Goggle Task performed just after the end of the rehabilitation program(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 just after the end of the rehabilitation program(Between 2 to 8 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(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 just after the end of the rehabilitation(Between 2 to 8 days after the 20th and last rehabilitation session)
- Romberg quotient collected 2 months after the end of the rehabilitation(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(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.(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 2 months after the end of the rehabilitation(Between 60 to 70 days after the 20th and last rehabilitation session.)
- Romberg quotient collected just after the end of the rehabilitation program.(Between 2 to 8 days after the 20th and last rehabilitation session)
- Monofilament test 10 g just after the end of the rehabilitation program.(Between 2 to 8 days after the 20th and last rehabilitation session.)
- Monofilament test 10 g, 2 months after the end of the rehabilitation.(Between 60 to 70 days after the 20th and last rehabilitation session.)
- Score of kinesthetic sensitivity in the lower limbs, 2 months after the end of the rehabilitation.(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(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(Between 60 to 70 days after the 20th and last rehabilitation session.)