Robotic Therapy Early After Stroke Events (R-TEASE)
Recruitment status was Not yet recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Robotic Therapy Early After Stroke Events|
- Fugl-Meyer score therapy. [ Time Frame: One month ] [ Designated as safety issue: No ]
- Feasibility [ Time Frame: One month ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- Modified Rankin scale score [ Time Frame: DAy 90 ] [ Designated as safety issue: No ]
- Barthel index [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
- Stroke Impact Scale [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
- NIHSS [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
- Action Research Arm Test [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||March 2015|
|Estimated Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01552733
|Western Infirmary, NHS Greater Glasgow and Clyde||Not yet recruiting|
|Glasgow, United Kingdom, G11 6NT|
|Contact: Jesse Dawson, MD firstname.lastname@example.org|
|Principal Investigator:||Jesse Dawson, MD||University of Glasgow|