Robotic Therapy Early After Stroke Events (R-TEASE)
|ClinicalTrials.gov Identifier: NCT01552733|
Recruitment Status : Completed
First Posted : March 13, 2012
Last Update Posted : January 27, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Device: 'Inmotion Arm Robot' Other: Standard of care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Robotic Therapy Early After Stroke Events|
|Actual Study Start Date :||March 1, 2012|
|Actual Primary Completion Date :||March 16, 2016|
|Actual Study Completion Date :||March 16, 2016|
Experimental: Robotic Therapy
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'
To improve limb function in those with limb impairment
Placebo Comparator: Standard Care
Rehabilitation therapy according to local guidelines.
Other: Standard of care
- Fugl-Meyer score therapy. [ Time Frame: One month ]
- Feasibility [ Time Frame: One month ]Defined as the proportion of individuals randomised to robotic intervention who complete 12 sessions of Robotic therapy. Will serve as a coprimary endpoint.
- Fugl-Meyer score. [ Time Frame: Day 90 ]
- Modified Rankin scale score [ Time Frame: DAy 90 ]
- Barthel index [ Time Frame: Day 90 ]
- Stroke Impact Scale [ Time Frame: Day 90 ]
- NIHSS [ Time Frame: Day 90 ]
- Action Research Arm Test [ Time Frame: Day 90 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01552733
|Western Infirmary, NHS Greater Glasgow and Clyde|
|Glasgow, United Kingdom, G11 6NT|
|Principal Investigator:||Jesse Dawson, MD||University of Glasgow|