Intensive Rehabilitation Program With Intensive Visual Numerical Simulation Device for Improving Distal Motor Performance and Upper Limb Functional Capacity in Subacute Hemiparetics After Stroke. Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 66
- 试验地点
- 5
- 主要终点
- Change of motor performance score on the Fugl-Meyer sub-score wrist/hand
研究概览
简要总结
Hemiparesis is a common motor disorder after a stroke. The majority of patients do not recover functional use of their paretic upper limb.
The use of mirror therapy allows the activation of the mirror neurons involved to stimulate brain plasticity after brain damage.The IVS (Intensive Visual Stimulation) device allows an easy implementation of mirror therapy by filming the valid upper limb and projecting the inverted image onto a screen placed above the parietal arm thus producing the illusion of movement of the parietal arm.
The main hypothesis of this study is that the structured practice of a large number of upper limb targeted movement repetitions using an intensive visual numerical simulation device as a partial replacement for routine care (conventional occupational therapy) in the sub-acute phase of stroke will increase the active function (motor function and functional abilities) of the distal end of the upper limb compared to conventional rehabilitation.
Objectives: This randomized controlled trial will evaluate the effects of partial substitution of routine care (occupational therapy) by structured movement repetition programs by Intensive Visual Simulation using an IVS3 device, on the distal motor control of the upper hemiparesis limb, between 4 and 10 weeks after the stroke, compared to a program with conventional care alone.
详细描述
Hemiparesis is a common motor disorder after a stroke. The majority of patients do not reuse their paretic upper limb.
Hypothesis: The structured practice of repeating upper limb movements by Intensive Visual Simulation will increase distal motor control, and improve the objective functional abilities of the upper limb.
Main Objective:Evaluate in a controlled protocol the effects, on the distal motor control of the upper hemiparesis limb, between 4 and 10 weeks after stroke, of 6 weeks of partial substitution of routine care (occupational therapy) by structured movement repetition programs by Intensive Visual Simulation using an IVS3 device, compared to 6 weeks of a program involving only conventional rehabilitation care, in a population of moderate to severe hemiparesis stroke patients in subacute phase.
Device Description: The IVS3 (Intensive Visual Simulation) rehabilitation device, marketed by Dessintey, allows the implementation of intensive mirror therapy by making it more immersive, ergonomic, and accessible. The IVS3 device consists of a hollow table adjustable in height, a touch screen dedicated to the therapist to set up the device and a large screen adjustable in height and sliding laterally to overlap the upper limb and thus allow the illusion that the limb visible on the screen is the paretic upper limb.
Methods: Multicentric randomised controlled Trial.
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)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years;
- •Stroke hemiparesis on unilateral focal lesion dating from 4 to 10 weeks at baseline;
- •Total sub-scores wrist and hand of th Fugl-Meyer < 16
- •Patient having agreed to sign an informed consent
- •patient being affiliated to the French Social Security
排除标准
- •Cognitive dysfunction or progressive intercurrent illness making effective communication or participation in the study impossible
- •Phasic disorders that prevent the understanding of instructions
- •Patient include in an other clinical trial
- •Neurological conditions prior to stroke
- •Patient who had mirror therapy or IVS rehabilitation before inclusion
- •Rheumatological pathology of the hand and wrist
- •Person under legal protection measure.
研究组 & 干预措施
Conventional Rehabilitation
at least 4 sessions/week for 6 weeks, from 1 hour of conventional upper limb rehabilitation by an occupational therapist.
干预措施: Conventional rehabilitation (Other)
Intensive Visual Simulation
at least 4 sessions/week for 6 weeks, of 1 hour of upper limb rehabilitation including 45 minutes of conventional rehabilitation (occupational therapy) and 15 minutes of work with a medical device allowing intensive visual digital simulation.
干预措施: Conventional rehabilitation (Other)
Intensive Visual Simulation
at least 4 sessions/week for 6 weeks, of 1 hour of upper limb rehabilitation including 45 minutes of conventional rehabilitation (occupational therapy) and 15 minutes of work with a medical device allowing intensive visual digital simulation.
干预措施: Intensive Visual Simulation (Device)
结局指标
主要结局
Change of motor performance score on the Fugl-Meyer sub-score wrist/hand
时间窗: between Day1(day of program start), Week6 (end of the program)
Fugl-Meyer (FM) assessment for measures of the motor impairment of the upper-limb; the sub-score wrist/hand includes items related to movements of the forearm (proximal arm), wrist, hand (distal arm) and speed/coordination during a finger-nose task. The total sub-score range between 0 and 30.
次要结局
- Change of motor performance score on the Fugl-Meyer(between Day1(day of program start), Week6 (end of the program) and Week18 (12 weeks after the end of the program))
- Change of motor capacity on Stroke Upper Limb Capacity Scale (SULCS)(between Day1(day of program start), Week6 (end of the program) and Week18 (12 weeks after the end of the program))
- Change of spasticity score of the elbow flexors, wrist flexors, finger flexors measured by the Modified Ashworth Scale (MAS)(between Day1(day of program start), Week6 (end of the program) and Week18 (12 weeks after the end of the program))
- Change in perceived stroke impact on the Stroke Impact Scale (SIS)(between Day1(day of program start), Week6 (end of the program) and Week18 (12 weeks after the end of the program))