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Robotic Therapy Early After Stroke Events (R-TEASE)

This study is not yet open for participant recruitment.
Verified March 2012 by NHS Greater Glasgow and Clyde
Sponsor:
Collaborator:
University of Glasgow
Information provided by (Responsible Party):
Dr Jesse Dawson, University of Glasgow
ClinicalTrials.gov Identifier:
NCT01552733
First received: March 9, 2012
Last updated: March 19, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention
Stroke
 Device: 'Inmotion Arm Robot'
Other: Standard of care

Study Type: Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources

Further study details as provided by NHS Greater Glasgow and Clyde:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 80
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)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01552733

Locations
United Kingdom
Western Infirmary, NHS Greater Glasgow and Clyde Not yet recruiting
Glasgow, United Kingdom, G11 6NT
Contact: Jesse Dawson, MD         jesse.dawson@glasgow.ac.uk    
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
University of Glasgow
Investigators
Principal Investigator: Jesse Dawson, MD University of Glasgow
  More Information

No publications provided

Responsible Party: Dr Jesse Dawson, Clinical Senior Lecturer in Medicine / Honorary Consultant, University of Glasgow
ClinicalTrials.gov Identifier: NCT01552733     History of Changes
Other Study ID Numbers: GN12MT023, R12/A141
Study First Received: March 9, 2012
Last Updated: March 19, 2012
Health Authority: United Kingdom: National Health Service

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on May 19, 2013