Robotic Therapy Early After Stroke Events (R-TEASE)

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 Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: 'Inmotion Arm Robot'; Other: Standard of care

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Glasgow, United Kingdom, G11 6NT
    • Western Infirmary, NHS Greater Glasgow and Clyde

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Rehabilitation Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fugl-Meyer score therapy.		One month
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: NHS Greater Glasgow and Clyde
• Collaborators: University of Glasgow

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2012
• Primary Completion (ACTUAL): March 16, 2016
• Study Completion (ACTUAL): March 16, 2016

Study Registration Dates

• First Submitted: March 9, 2012
• First Submitted That Met QC Criteria: March 12, 2012
• First Posted (ESTIMATE): March 13, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): January 27, 2017
• Last Update Submitted That Met QC Criteria: January 26, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: GN12MT023; R12/A141 (OTHER_GRANT: Chest Heart and Stroke Scotland)