Robotic Rehabilitation of the Upper Limb After a Stroke

Study Overview
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Brief Summary
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Hemiparesis is the most common motor disorder after a stroke. Most patients do not recover functional use of their paretic upper limb. The use of robotic assistance provides intensive motor training through a large number of repetitive movements, usually oriented and interactive tasks (pointing tasks, tracking paths tasks...). These feature have been demonstrated to be critical to stimulate brain plasticity after a brain damage. The InMotion Arm 2.0 manipulator works with an adaptive algorithm that provide patients with real-time Assistance-as-Needed™ desgned to enhance motor performance. Hypothesis: In the sub-acute phase of stroke, the structured practice of a large number of repeated movements will increase motor function of the upper limb compared to conventional rehabilitation. Secondly, this practice will be more effective in a free active mode (without assistance) than an active assisted mode (Assistance-as-Needed™). Expected secondary benefits: Subjective impression of improved use of the upper limb in activities of daily living and reduction of spastic cocontractions affecting the agonist and antagonist muscles during movements of the upper limb. Objectives: This randomized controlled trial will evaluate the effects of structured repetition programs of arm movements, on the function of the hemiparetic upper limb and motor control, between 4 and 10 weeks after the stroke, using a robotic device with or without assistance in partial substitution of conventional rehabilitation care, compared to a program with conventional care alone.

Official Title
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Rehabilitation Program With Robotic Assistance for the Improvement of Motor Performance and Functional Use of the Upper Limb in Subacute Hemiparetic. Multicenter Randomized Controlled Trial

Conditions
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Stroke

Intervention / Treatment
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* Device: Robot InMotion 2.0
* Other: Conventional rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years; Stroke hemiparesis on unilateral focal lesion dating from 4 to 10 weeks at baseline; Active flexion of the paretic shoulder ≥15 °; Average score on the modified scale of Frenchay <5; Patient having agreed to sign an informed consent. Exclusion Criteria: Passive extension of the paretic elbow <120 °; Passive extension of the paretic wrist <10 °; Cognitive dysfunction or progressive intercurrent illness making effective communication or participation in the study impossible; Infection, inflammation or complex regional pain syndrome of the paretic upper extremity; Injection of botulinum toxin to the upper limb less than 3 months old; Patient under safeguard of justice; Patient include in an other clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional rehabilitation<br>5 sessions / week of 1 hour of occupational therapy | Other: Conventional rehabilitation<br>* Conventional rehabilitation implemented by an occupational therapist, involving stretching movements in submaximal passive amplitude, inhibition postures (Bobath), active efforts assisted of varied difficulty, exercises of direction of the arm towards a target with or without elbow support and grasping tasks, adapted to the capacities of the paretic upper limb.<br>|
| Active Comparator: Robotic rehabilitation with assistance<br>5 sessions / week of 1 hour of rehabilitation of the upper limb with 30 min of conventional rehabilitation and 30 min of robotic rehabilitation with assistance. | Device: Robot InMotion 2.0<br>* Repetitive work of large numbers of targeted alternative movements with or without assistance. The passage between with and without assistance taking place according to the evolution of performance judged by the investigator therapist. Note that the duration of the training using the assisted mode should be at least 3 weeks, i.e. half of the total duration of treatment.<br>Other: Conventional rehabilitation<br>* Conventional rehabilitation implemented by an occupational therapist, involving stretching movements in submaximal passive amplitude, inhibition postures (Bobath), active efforts assisted of varied difficulty, exercises of direction of the arm towards a target with or without elbow support and grasping tasks, adapted to the capacities of the paretic upper limb.<br>|
| Active Comparator: Non-assistance robotic rehabilitation<br>5 sessions / week of 1 hour of rehabilitation of the upper limb including 30 min of conventional rehabilitation and 30 min of robotic rehabilitation without assistance. | Device: Robot InMotion 2.0<br>* Repetitive work of large numbers of targeted alternative movements with or without assistance. The passage between with and without assistance taking place according to the evolution of performance judged by the investigator therapist. Note that the duration of the training using the assisted mode should be at least 3 weeks, i.e. half of the total duration of treatment.<br>Other: Conventional rehabilitation<br>* Conventional rehabilitation implemented by an occupational therapist, involving stretching movements in submaximal passive amplitude, inhibition postures (Bobath), active efforts assisted of varied difficulty, exercises of direction of the arm towards a target with or without elbow support and grasping tasks, adapted to the capacities of the paretic upper limb.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional performance score change on Modified Frenchay Scale | The scale measures active upper limb function in hemiparesis based on 10 everyday living tasks, each rated on a 10-point visual analogic scale. Six tasks are bimanual and four are unimanual performed with the paretic hand. Final score is an average of the 10 subscores (10 is the higher score). | Between the pre-rehabilitation state on the day of program start (Day1) and the state at the end of the program (Week6) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional performance score change on Modified Frenchay Scale | The scale measures active upper limb function in hemiparesis based on 10 everyday living tasks, each rated on a 10-point visual analogic scale. Six tasks are bimanual and four are unimanual performed with the paretic hand. Final score is an average of the 10 subscores (10 is the higher score). | between Day1 (day of program start) and Week22 (16 weeks after the end of the program) | 
| Change of motor performance score on the Fugl-Meyer score | Fugl-Meyer (FM) assessment for measures of the motor impairment of the upper-limb; the test includes items related to movements of the shoulder, elbow, forearm (proximal arm), and wrist and hand (distal arm). The total scores range between 0 and 66. | between Day1(day of program start), Week6(end of the program) and Week22 (16 weeks after the end of the program) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Robot,, Rehabilitation, Hemiparesis, Upper limb, Function, Motor control