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| ID | Type | Description | Link |
|---|---|---|---|
| R12/A141 | Other Grant/Funding Number | Chest Heart and Stroke Scotland |
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| Name | Class |
|---|---|
| University of Glasgow | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic Therapy | Experimental | 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. |
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| Standard Care | Placebo Comparator | Rehabilitation therapy according to local guidelines. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 'Inmotion Arm Robot' | Device | To improve limb function in those with limb impairment |
| |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Fugl-Meyer score. | Day 90 | |
| Modified Rankin scale score | DAy 90 | |
| Barthel index |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jesse Dawson, MD | University of Glasgow | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Western Infirmary, NHS Greater Glasgow and Clyde | Glasgow | G11 6NT | United Kingdom |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of care |
| Other |
Rehabilitation Therapy |
|
| Day 90 |
| Stroke Impact Scale | Day 90 |
| NIHSS | Day 90 |
| Action Research Arm Test | Day 90 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |