Augmented visual feedback in upper limb stroke rehabilitation

ISRCTN ISRCTN14268457
DOI https://doi.org/10.1186/ISRCTN14268457
Secondary identifying numbers G0900583
Submission date
10/08/2011
Registration date
21/09/2011
Last edited
02/10/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
A stroke is a serious, life-threatening medical condition that occurs when the blood supply to part of the brain is cut off. Many stroke survivors have limited arm function, decreasing their independence and quality of life. Rehabilitation to encourage functional arm recovery is based on practice of everyday tasks and feedback. Visual feedback is known to support relearning and is already used by therapists with the aid of mirrors or video. However, neither method is optimal as both rely on subjective observation rather than an accurate analysis of the patient’s movement. Stroke survivors can also be distracted or distressed by their appearance. In this study we propose to provide improved visual feedback by recording a patient's arm movements using motion capture technology to create a stick-like figure that will mimic the patient’s movements on a computer screen. The simple feedback will highlight the success and quality of those movements. The aim of this study is to assess the effectiveness of this additional visual feedback as part of stroke rehabilitation.

Who can participate?
Adults aged 18 or over up to 3 months from time of onset of stroke and with limited arm function

What does the study involve?
Participants are randomly allocated into one of three groups. The first group receive the usual therapy that would be provided from the Early Supported Discharge (ESD) team. The second group receive arm therapy focusing on reach and grasp, the same exercises as for the third group but without visual feedback. This takes place at a community-based clinic, one hour twice a week for six weeks, in addition to standard care. The third group receive one hour of enhanced arm therapy with improved visual feedback twice a week at a community-based clinic for 6 weeks, in addition to any standard care. All participants are followed up for 6 months.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
University of Strathclyde (UK). Participants are recruited at discharge from acute stroke wards across NHS Lanarkshire

When is the study starting and how long is it expected to run for?
October 2011 to April 2013

Who is funding the study?
Lifelong Health and Wellbeing (LLHW): a cross-research council initiative in partnership with the UK health departments and led by the Medical Research Council (MRC) (UK)

Who is the main contact?
Lucy Jones
lucy.jones@strath.ac.uk

Study website

Contact information

Miss Lucy Jones
Scientific

Department of Bioengineering
Wolfson Building
University of Strathclyde
106 Rottenrow
Glasgow
G4 0NW
United Kingdom

Phone +44 (0) 141 548 3028
Email lucy.jones@strath.ac.uk

Study information

Study designInterventional single-blind single-centre randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleThe impact of augmented visual feedback in upper limb rehabilitation in sub-acute stroke: a pilot randomised controlled trial
Study objectivesDoes the use of augmented visual feedback of biomechanical movement performance in upper limb rehabilitation improve functional outcomes after stroke?
Ethics approval(s)NHS West of Scotland Research Ethics Committee 2, 15/06/2011, REC ref: 11/AL/0260
Health condition(s) or problem(s) studiedStroke
InterventionStroke patients with upper limb impairments who meet inclusion criteria will be randomised into one of three groups:

1. Control group: This is standard care (SC) only and is usual therapy that would be provided, i.e. from the Early Supported Discharge (ESD) team.
2. Placebo group: Upper limb therapy focusing on reach and grasp, the same exercises as for the intervention group but without visual feedback. This will take place at a community-based clinic, one hour twice a week for six weeks, in addition to any received SC.
3. Intervention Group: One hour of enhanced upper limb therapy twice a week at a community-based clinic for 6 weeks, in addition to any SC. During the sessions patients will receive augmented visual feedback during upper limb exercises.
Intervention typeBehavioural
Primary outcome measureArm function assessed by the Action Research Arm Test (ARAT) at baseline, six weeks and six months
Secondary outcome measures1. Kinematic (temporal and spatial parameters) assessment measured using sensors worn during a section of the ARAT
2. Hand function measured by the 9 Hole Peg Test
3. Stroke Impact Scale - to evaluate quality of life and disability changes
Measured at baseline, six weeks and six months

Additional outcome measures:
1. A patient and therapist questionnaire at 6 weeks to assess the acceptance of the visualisation system from their perspective
2. The safety of intervention assessed by number and nature of adverse events at end of intervention period and at follow up
3. Acceptance of the visualisation system will be assessed by withdrawal or dropout rates from study
Overall study start date01/10/2011
Completion date01/04/2013

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants45
Key inclusion criteria1. Aged more than or equal to 18 years
2. Clinical diagnosis of stroke
3. Sub-acute stage of stroke (up to three months from time of onset of stroke)
4. Some movement in affected arm and/or hand - Action Research Arm Test (ARAT) score of 4-56 (57 max score)
5. Medically stable hence suitable for physical rehabilitation
6. Ability to understand and follow simple instructions
7. Able to give informed consent when assisted to do so with suitable communication aids
Key exclusion criteria1. Pre-existing upper limb deficits
2. Bilateral arm impairments
3. Severe visual or cognitive problems precluding participation in study protocol
4. Involved in any other intervention study
Date of first enrolment01/10/2011
Date of final enrolment01/04/2013

Locations

Countries of recruitment

  • Scotland
  • United Kingdom

Study participating centre

University of Strathclyde
Glasgow
G4 0NW
United Kingdom

Sponsor information

University of Strathclyde (UK)
University/education

Contracts Manager
c/o Louise McKean
Research & Knowledge Exchange Services
50 George Street
Glasgow
G1 1QE
Scotland
United Kingdom

Website http://www.strath.ac.uk/
ROR logo "ROR" https://ror.org/00n3w3b69

Funders

Funder type

Research council

Medical Research Council (MRC) (UK) - Lifelong Health and Wellbeing (Phase 2), Ref number: G0900583, Grant ID: 91021

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

02/10/2017: No publications found, verifying study status with principal investigator.