Robotic Therapy Early After Stroke Events

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Other: Standard of care; Device: 'Inmotion Arm Robot'

• Registration Number: NCT01552733
• Lead Sponsor: NHS Greater Glasgow and Clyde

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-01
• Study First Submitted: 2012-03-09
• Study First Submitted QC: 2012-03-12
• Study First Posted: 2012-03-13
• Primary Completion: 2016-03-16
• Study Completion: 2016-03-16
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-26
• Last Update Posted: 2017-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Aged > 18 years
2. Confirmed diagnosis of stroke
3. Randomisation by seven days
4. Upper limb impairment, defined as a measurable upper limb impairment on the NIHSS and a baseline upper limb FuglMeyer score of <50 at randomisation
5. Able to comply with the requirements of the protocol

Exclusion Criteria

1. Other significant upper limb impairment e.g. fixed contracture, fracture, frozen shoulder, severe arthritis, amputation.
2. Diagnosis likely to interfere with rehabilitation or outcome assessments such as registered blind or terminal illness.
3. Participation in other stroke rehabilitation trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Care	Standard of care	Rehabilitation therapy according to local guidelines.
Robotic Therapy	'Inmotion Arm Robot'	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.

Primary Outcome Measures

Name	Time	Method
Feasibility	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 therapy.	One month

Secondary Outcome Measures

Name	Time	Method
Modified Rankin scale score	DAy 90
Fugl-Meyer score.	Day 90
Action Research Arm Test	Day 90
Stroke Impact Scale	Day 90
Barthel index	Day 90
NIHSS	Day 90

Trial Locations

Locations (1)

Western Infirmary, NHS Greater Glasgow and Clyde; 🇬🇧 Glasgow, United Kingdom