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
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
Contact information
Scientific
Department of Bioengineering
Wolfson Building
University of Strathclyde
106 Rottenrow
Glasgow
G4 0NW
United Kingdom
| Phone | +44 (0) 141 548 3028 |
|---|---|
| lucy.jones@strath.ac.uk |
Study information
| Study design | Interventional single-blind single-centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | The impact of augmented visual feedback in upper limb rehabilitation in sub-acute stroke: a pilot randomised controlled trial |
| Study objectives | Does 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) studied | Stroke |
| Intervention | Stroke 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 type | Behavioural |
| Primary outcome measure | Arm function assessed by the Action Research Arm Test (ARAT) at baseline, six weeks and six months |
| Secondary outcome measures | 1. 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 date | 01/10/2011 |
| Completion date | 01/04/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 45 |
| Key inclusion criteria | 1. 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 criteria | 1. 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 enrolment | 01/10/2011 |
| Date of final enrolment | 01/04/2013 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
G4 0NW
United Kingdom
Sponsor information
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" |
https://ror.org/00n3w3b69 |
Funders
Funder type
Research council
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
02/10/2017: No publications found, verifying study status with principal investigator.
