Therapeutic Effects of a New Upper Limb Robot Assisted Therapy Device for Persons After Stroke

Study Overview
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Brief Summary
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The purpose of this pilot study is to investigate the clinical effects of a new upper limb robot assisted therapy device that is linked to a virtual therapy environment in patients with stroke.

Detailed Description
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The number of physically weak individuals is increasing, resulting in a higher burden on health care and health care workers. The use of robot assisted therapy (RAT) might partly solve this problem. Rehabilitation progress highly depends on training intensity and training duration, favouring the use of RAT. In this pilot study, the clinical effects of using a new upper arm RAT device for upper arm rehabilitation in patients with stroke is investigated. Myo-electrical signals will serve as input for the device, assisting the user in flexion and extension of the elbow. The device is coupled to a virtual environments, creating a stimulating therapy environment.

Official Title
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Active Smart Wearable Orthosis Using Painted EMG Electrodes for Home Based Therapy With Augmentative Feedback

Conditions
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Stroke

Intervention / Treatment
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* Device: Training with new upper limb robot assisted therapy device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with stroke, more than three months post onset No or moderate spasticity in the upper limb (maximum score of 3 on Modified Ashworth Scale) Observable voluntary muscle activity in biceps and triceps muscle of the affected upper limb (minimal score of 1 on the Medical research council score) Able to sit on a chair with adequate trunk stability Able to follow verbal instructions Able to communicate verbal information to the researchers Exclusion Criteria: Patients who are medically unstable Cognitive disorders impeding the intervention Visual disorders impeding the intervention Subluxation of the shoulder joint Pusher syndrome

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Supportive Care
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Training with the device<br>Training with new upper limb robot assisted therapy device | Device: Training with new upper limb robot assisted therapy device<br>* During 8 weeks, 3 times a week, 1 hour therapy sessions with the device<br>* Other names: exoskeleton;|
| No Intervention: Control group<br>The control group is treated with conventional therapy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer test upper limb section | Stroke specific, performance based impairment index. Applied to determine disease severity and describe motor recovery. | Change from baseline Fugl-Meyer test upper limb section at 8 weeks and 12 weeks | 
| Medical research council score | Muscle strength assessment | Change from baseline Medical research council score at 8 weeks and 12 weeks | 
| Active range of motion of the elbow joint | The maximum range of motion to flexion and extension of the elbow joint that the person can achieve independently | Change from baseline active range of motion of the elbow joint at 8 weeks and 12 weeks | 
| Passive range of motion of the elbow joint | The maximum range of motion to flexion and extension of the elbow joint of the test person that can be achieved by the assessor. | Change from baseline passive range of motion of the elbow joint at 8 weeks and 12 weeks | 
| Modified Ashworth Scale | Spasticity measurement | Change from baseline Modified Ashworth Scale at 8 weeks and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ABILHAND questionnaire | Questionnaire-based assessment of manual ability | Change from baseline ABILHAND questionnaire score at 8 weeks and 12 weeks | 
| Functional independence measure | Assessment of physical and cognitive disability, focusing on the burden of care. | Change from baseline Functional independence measure score at 8 weeks and 12 weeks | 
| Stroke impact scale | Questionnaire evaluating how stroke has impacted the person's health and life. | Change from baseline Stroke impact scale score at 8 weeks and 12 weeks | 
| Intrinsic motivation inventory | Multidimensional measurement device intended to assess participants' subjective experience related to a target activity in laboratory experiments. | Change from baseline Intrinsic motivation inventory score at 8 weeks and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Upper extremity, Rehabilitation, Robot assisted therapy, Robotics, Devices, Orthosis, clinical outcome