NEO-REEDUC - Mixed Reality for Motor Rehabilitation: a Prospective, Multicenter, Controlled, Randomized, Open Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Slb Pharma
- 入组人数
- 76
- 试验地点
- 5
- 主要终点
- Change in postural stability measured by the Mini-BesTest (or Kids Mini-BesTest) for children.
研究概览
简要总结
This study aims to assess the effectiveness of a motor rehabilitation protocol that includes mixed reality activities, compared to conventional rehabilitation, on postural stability in children and adult patients with neurological impairments.
详细描述
Conventional motor rehabilitation techniques applied to postural stability, locomotion or the upper limbs suffer from certain limitations. Studies in this field have highlighted the length and repetitiveness of these programs, which can lead to patient fatigue and pain. Combined with the lack of recreation and ecology in conventional therapies, which are often decontextualized and highly simplified, all these factors contribute to the lack of transposition of the improvements obtained into daily life activities (DLAs).
For several years now, the use of virtual reality (VR) and mixed reality (MR) have emerged as one of the most interesting solutions for overcoming these limitations. These technologies enable patients to take part in rehabilitation protocols under more controlled, progressive and attractive conditions, encouraging better patient adherence. These aspects guarantee effective rehabilitation and generalization of benefits to DLAs. In addition, they involve visuomotor coordination (skills involving the coordination of movements of different body segments with visual information previously perceived during execution), which is a cognitive ability widely transposable to DLAs.
Although some previous studies have investigated the effects of VR for motor rehabilitation, this technology also presents practical limitations related to the discomfort induced by the head-mounted displays (cybersickness, and physical discomforts caused by the weight of the display). Moreover, the use of VR tends to isolate the patient from their environment and therefore limits interaction with practitioners. Nevertheless, findings have shown the benefits of a VR protocol applied to motor rehabilitation in children and teenagers with cerebral palsy. The accuracy precision and fluidity of upper limb movements was improved, and the adherence to the protocol was strong.
In the line of these findings, the present protocol has several objectives: (1) to use MR, which seems to offer more possibilities while avoiding the disadvantages associated with VR, (2) to extend the applications of the proposed virtual rehabilitation tasks to other major motor functions - postural stability and locomotion as additional targets - and (3) to deploy these new rehabilitation methods to other patients likely to benefit from them (i.e. those with a functional disorder of neurological origin affecting their motor skills).
This study will include 120 patients with motor deficiencies of neurological origin, who will be randomly divided into two groups: one group receiving three weekly mixed reality rehabilitation sessions for four weeks, and a control group only following its usual care in the same period. Participants will be randomly matched for pathology, postural stability scores, age and sex. The effectiveness of the rehabilitation protocol will be evaluated through several clinical indicators of postural stability, locomotion and limb mobility as well as psychometrical measurements of fatigue, pain, motivation and quality of life.
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
The care providers will perform the 4-week rehabilitation program for the experimental group. The outcome assessors will only be in charge of the pre and post-test phases, and will not be informed on which group each participant was assigned to. All participants will receive a pseudonym which provides no information on their respective group.
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Adult patient (18 years old or older) with motor disorders related to a deficit in postural stability (mini-BESTest ≤ 25) which may be associated with a deficit in the use of upper limbs and locomotion, consecutive to : 1) either acquired neurological impairments (ischemic or hemorrhagic stroke in sub-acute or chronic phase, head trauma, benign tumor operated on with complete removal, cerebral anoxia) , or 2) a neurodegenerative affection (Parkinson's disease, Multiple Sclerosis).
- •Child or teenager patient (6 to 17 years old) with motor disorders related to a deficit in postural stability (mini-BESTest ≤ 25) which may be associated with a deficit in the use of upper limbs and locomotion, consecutive to 1) either spastic, dyskinetic or ataxic cerebral palsy, or 2) a similar impairment without diagnosis or of another etiology.
- •Patient able to walk with or without technical aids and to perform voluntary upper limb movements.
- •Patient able to understand and follow instructions or adapted communication.
- •Patient having given written informed consent concerning his/her participation in the protocol OR (for children) whose parents have given their written informed consent.
- •Patient covered by social security.
排除标准
- •Patient with a severe intellectual disability.
- •Patient with a severe attention deficit disorder.
- •Patient whose epilepsy is not stable.
- •Patient with pain preventing participation in the intended tasks of the protocol.
- •Patient with an illness, medical condition or treatment incompatible with participation in the protocol.
- •Patient with multiple sclerosis with relapse less than 3 months old.
- •Simultaneous participation in other interventional research (1) that may exclude participation in the present study or (2) for which the exclusion period has not ended and whose nature may possibly impact the results of the present research.
- •In addition, the vulnerable persons mentioned in Articles L. 1121-5, L.1121-6 and L.1121-8 of the French Public Health Code are excluded from the study:
- •Pregnant, nursing or parturient women.
- •Persons deprived of their liberty by judicial or administrative decision, hospitalized without consent or admitted to a health or social institution for purposes other than research.
- •Adults under legal protection or unable to express their consent.
研究组 & 干预措施
Mixed Reality Group
Patients will receive a mixed reality rehabilitation protocol for 4 weeks, on the basis of 3 sessions per week. These sessions will replace up to 3 usual motor rehabilitation sessions in order to limit any major increase in motor solicitations during this period.
干预措施: Mixed Reality Rehabilitation (Device)
Control Group
Patients who will be assigned to the control group will follow their usual care for 4 weeks (usual motor activity, including rehabilitation and sports or physical activities). The rehabilitation protocol will be proposed after the second post-test phase.
结局指标
主要结局
Change in postural stability measured by the Mini-BesTest (or Kids Mini-BesTest) for children.
时间窗: Pre-test (week 1), post-test (week 6) and 2-month follow-up (week 14).
The test measures 5 aspects of postural stability in static and dynamic configurations over 14 items. Scores range from 0 to 28. A higher score indicates an overall better postural stability.
次要结局
- Change in postural stability measured by the Functional Reach Test.(Pre-test (week 1), post-test (week 6) and 2-month follow-up (week 14).)
- Change in locomotor ability measured by the 6-minute walk test (6MWT) and the 10-meter walk test (10MWT).(Pre-test (week 1), post-test (week 6) and 2-month follow-up (week 14).)
- Change in limb mobility measured by goniometry and a specific task implemented in the Mixed reality system.(Pre-test (week 1), post-test (week 6) and 2-month follow-up (week 14).)
- Change in quality of life measured by the MHAVIE questionnaire (measure of life habits).(Pre-test (week 1), post-test (week 6) and 2-month follow-up (week 14).)
- Change in pain, fatigue and motivation during the rehabilitation(Once at the beginning of the rehabilitation period (week 2) and once at the end of each week until the end of this period (weeks 2 to 5).)
- Change in cinematic parameters of upper limb movements and locomotion during the virtual activities (experimental group only).(For each trial of every virtual activity during the rehabilitation phase (weeks 2 to 5).)
- Progression in difficulty levels of the virtual activities (experimental group only).(For each trial of every virtual activity during the rehabilitation phase (weeks 2 to 5).)
- User experience measures as perceived by the care providers involved in the mixed reality rehabilitation protocol, using the AttrakDiff, UEQ and meCUE questionnaires.(At one point during the rehabilitation phase (during week 4 or 5).)