Robotic Therapy Early After Stroke Events

Stroke Clinical Trial

— R-TEASE  

Official title:

Robotic Therapy Early After Stroke Events

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01552733
• Other study ID #: GN12MT023
• Secondary ID: R12/A141
• Status: Completed
• Phase: N/A
• First received: March 9, 2012
• Last updated: January 26, 2017
• Start date: March 1, 2012
• Est. completion date: March 16, 2016

Study information

• Verified date: January 2017
• Source: NHS Greater Glasgow and Clyde
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 16, 2016
• Est. primary completion date: March 16, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• 'Inmotion Arm Robot'
To improve limb function in those with limb impairment

Other:
• Standard of care
Rehabilitation Therapy

Locations

Country	Name	City	State
United Kingdom	Western Infirmary, NHS Greater Glasgow and Clyde	Glasgow

Sponsors (2)

Lead Sponsor	Collaborator
NHS Greater Glasgow and Clyde	University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl-Meyer score therapy.		One month
Primary	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	Fugl-Meyer score.		Day 90
Secondary	Modified Rankin scale score		DAy 90
Secondary	Barthel index		Day 90
Secondary	Stroke Impact Scale		Day 90
Secondary	NIHSS		Day 90
Secondary	Action Research Arm Test		Day 90