Robotic Therapy Early After Stroke Events (R-TEASE)

This study is not yet open for participant recruitment. (see Contacts and Locations)
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

March 9, 2012
March 19, 2012
March 2012
March 2015   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01552733 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Robotic Therapy Early After Stroke Events
Robotic Therapy Early After Stroke Events

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Stroke
  • Device: 'Inmotion Arm Robot'
    To improve limb function in those with limb impairment
  • Other: Standard of care
    Rehabilitation Therapy
  • 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.
    Intervention: Device: 'Inmotion Arm Robot'
  • Placebo Comparator: Standard Care
    Rehabilitation therapy according to local guidelines.
    Intervention: Other: Standard of care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
80
March 2015
March 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
United Kingdom
 
NCT01552733
GN12MT023, R12/A141
No
Dr Jesse Dawson, University of Glasgow
NHS Greater Glasgow and Clyde
University of Glasgow
Principal Investigator: Jesse Dawson, MD University of Glasgow
NHS Greater Glasgow and Clyde
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP