Robotic Therapy Early After Stroke Events

Study Overview
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Brief Summary
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Weakness and impairment of the upper limb is a common contributing factor to post stroke disability. Specially designed robotic systems have been developed to try to improve this. The investigators already know that their use helps improve limb function after stroke when it has been present for many months. The investigators do not know whether they can help early after stroke and enhance recovery of limb function, and perhaps prevent weakness becoming chronic. The investigators plan a randomised controlled blinded study to explore the benefits of robot assisted therapy early after stroke in 80 stroke survivors. Participants will be randomised by 7 days after stroke to standard care or to robotic therapy (40 participants per study group). Standard of care will be rehabilitation therapy according to local guidelines delivered by NHS multidisciplinary team. Robotic therapy sessions lasts approximately one hour and consists of a series of tasks in first the unimpaired then impaired limb. The robotic-assisted therapy will consist of a series of taks including circle-drawing, reaching targets and holding/moving against moderate resistance. Twelve sessions of therapy within the first 4 weeks after randomisation will be delivered. This study will take 3 years to complete.

Official Title
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Robotic Therapy Early After Stroke Events

Conditions
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Stroke

Intervention / Treatment
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* Device: 'Inmotion Arm Robot'
* Other: Standard of care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged > 18 years Confirmed diagnosis of stroke Randomisation by seven days Upper limb impairment, defined as a measurable upper limb impairment on the NIHSS and a baseline upper limb FuglMeyer score of <50 at randomisation Able to comply with the requirements of the protocol Exclusion Criteria: Other significant upper limb impairment e.g. fixed contracture, fracture, frozen shoulder, severe arthritis, amputation. Diagnosis likely to interfere with rehabilitation or outcome assessments such as registered blind or terminal illness. Participation in other stroke rehabilitation trial.

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Experimental: Robotic Therapy<br>Robotic Therapy using 'Inmotion' device plus standard care. Participants randomised to robotic therapy will receive up to 12 sessions (approximately 1 hour each) performing tasks (including circle drawing, reaching targets and holding/moving against moderate resistance. | Device: 'Inmotion Arm Robot'<br>* To improve limb function in those with limb impairment<br>|
| Placebo Comparator: Standard Care<br>Rehabilitation therapy according to local guidelines. | Other: Standard of care<br>* Rehabilitation Therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer score therapy. |  | One month | 
| Feasibility | Defined as the proportion of individuals randomised to robotic intervention who complete 12 sessions of Robotic therapy. Will serve as a coprimary endpoint. | One month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer score. |  | Day 90 | 
| Modified Rankin scale score |  | DAy 90 | 
| Barthel index |  | Day 90 | 
| Stroke Impact Scale |  | Day 90 | 
| NIHSS |  | Day 90 | 
| Action Research Arm Test |  | Day 90 |