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Robotic Therapy Early After Stroke Events (R-TEASE)

This study has been completed.
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: January 26, 2017
Last verified: January 2017
  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
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
Primary Purpose: Treatment
Official Title: Robotic Therapy Early After Stroke Events

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

Primary Outcome Measures:
  • Fugl-Meyer score therapy. [ Time Frame: One month ]
  • Feasibility [ Time Frame: 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.


Secondary Outcome Measures:
  • Fugl-Meyer score. [ Time Frame: Day 90 ]
  • Modified Rankin scale score [ Time Frame: DAy 90 ]
  • Barthel index [ Time Frame: Day 90 ]
  • Stroke Impact Scale [ Time Frame: Day 90 ]
  • NIHSS [ Time Frame: Day 90 ]
  • Action Research Arm Test [ Time Frame: Day 90 ]

Enrollment: 80
Actual Study Start Date: March 1, 2012
Study Completion Date: March 16, 2016
Primary Completion Date: March 16, 2016 (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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01552733

Locations
United Kingdom
Western Infirmary, NHS Greater Glasgow and Clyde
Glasgow, United Kingdom, G11 6NT
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
University of Glasgow
Investigators
Principal Investigator: Jesse Dawson, MD University of Glasgow
  More Information

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 ( Other Grant/Funding Number: Chest Heart and Stroke Scotland )
Study First Received: March 9, 2012
Last Updated: January 26, 2017

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

ClinicalTrials.gov processed this record on March 24, 2017