Robotic Therapy Early After Stroke Events

NCT ID: NCT01552733

Last Updated: 2017-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-01
• Study Completion Date: 2016-03-16

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

'Inmotion Arm Robot'

Intervention Type: DEVICE

To improve limb function in those with limb impairment

Standard Care

Rehabilitation therapy according to local guidelines.

Group Type: PLACEBO_COMPARATOR

Standard of care

Intervention Type: OTHER

Rehabilitation Therapy

Interventions

'Inmotion Arm Robot'

To improve limb function in those with limb impairment

Intervention Type: DEVICE

Standard of care

Rehabilitation Therapy

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Glasgow

OTHER

Sponsor Role: collaborator

NHS Greater Glasgow and Clyde

OTHER

Sponsor Role: lead

Responsible Party

Dr Jesse Dawson

Clinical Senior Lecturer in Medicine / Honorary Consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jesse Dawson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Glasgow

Locations

Western Infirmary, NHS Greater Glasgow and Clyde

Glasgow, , United Kingdom

Countries

United Kingdom

Other Identifiers

R12/A141

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

GN12MT023

Identifier Type: -

Identifier Source: org_study_id