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Robotic Therapy Early After Stroke Events (R-TEASE)

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
'Inmotion Arm Robot'
Standard of care
Sponsored by
NHS Greater Glasgow and Clyde
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Western Infirmary, NHS Greater Glasgow and Clyde

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Robotic Therapy

Standard Care

Arm Description

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.

Rehabilitation therapy according to local guidelines.

Outcomes

Primary Outcome Measures

Fugl-Meyer score therapy.
Feasibility
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.
Modified Rankin scale score
Barthel index
Stroke Impact Scale
NIHSS
Action Research Arm Test

Full Information

First Posted
March 9, 2012
Last Updated
January 26, 2017
Sponsor
NHS Greater Glasgow and Clyde
Collaborators
University of Glasgow
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1. Study Identification

Unique Protocol Identification Number
NCT01552733
Brief Title
Robotic Therapy Early After Stroke Events
Acronym
R-TEASE
Official Title
Robotic Therapy Early After Stroke Events
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
March 1, 2012 (Actual)
Primary Completion Date
March 16, 2016 (Actual)
Study Completion Date
March 16, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
NHS Greater Glasgow and Clyde
Collaborators
University of Glasgow

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Robotic Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Care
Arm Type
Placebo Comparator
Arm Description
Rehabilitation therapy according to local guidelines.
Intervention Type
Device
Intervention Name(s)
'Inmotion Arm Robot'
Intervention Description
To improve limb function in those with limb impairment
Intervention Type
Other
Intervention Name(s)
Standard of care
Intervention Description
Rehabilitation Therapy
Primary Outcome Measure Information:
Title
Fugl-Meyer score therapy.
Time Frame
One month
Title
Feasibility
Description
Defined as the proportion of individuals randomised to robotic intervention who complete 12 sessions of Robotic therapy. Will serve as a coprimary endpoint.
Time Frame
One month
Secondary Outcome Measure Information:
Title
Fugl-Meyer score.
Time Frame
Day 90
Title
Modified Rankin scale score
Time Frame
DAy 90
Title
Barthel index
Time Frame
Day 90
Title
Stroke Impact Scale
Time Frame
Day 90
Title
NIHSS
Time Frame
Day 90
Title
Action Research Arm Test
Time Frame
Day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged > 18 years Confirmed diagnosis of stroke Randomisation by seven days Upper limb impairment, defined as a measurable upper limb impairment on the NIHSS and a baseline upper limb FuglMeyer score of <50 at randomisation Able to comply with the requirements of the protocol Exclusion Criteria: Other significant upper limb impairment e.g. fixed contracture, fracture, frozen shoulder, severe arthritis, amputation. Diagnosis likely to interfere with rehabilitation or outcome assessments such as registered blind or terminal illness. Participation in other stroke rehabilitation trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesse Dawson, MD
Organizational Affiliation
University of Glasgow
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western Infirmary, NHS Greater Glasgow and Clyde
City
Glasgow
ZIP/Postal Code
G11 6NT
Country
United Kingdom

12. IPD Sharing Statement

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Robotic Therapy Early After Stroke Events

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