Plain English Summary
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 will be randomly allocated into one of three groups. The first group will receive the usual therapy that would be provided from the Early Supported Discharge (ESD) team. The second group will receive arm therapy focusing on reach and grasp, the same exercises as for the third 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 standard care. The third group will 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 will be 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 will be recruited at discharge from acute stroke wards across NHS Lanarkshire.
When is the study starting and how long is it expected to run for?
From 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
Trial website
http://www.envisagerehab.co.uk/content/wp4a-envisage-stroke-rehabilitation-upper-limb
Contact information
Type
Scientific
Primary contact
Miss Lucy Jones
ORCID ID
Contact details
Department of Bioengineering
Wolfson Building
University of Strathclyde
106 Rottenrow
Glasgow
G4 0NW
United Kingdom
+44 (0) 141 548 3028
lucy.jones@strath.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G0900583
Study information
Scientific title
The impact of augmented visual feedback in upper limb rehabilitation in sub-acute stroke: a pilot randomised controlled trial
Acronym
Study hypothesis
Does the use of augmented visual feedback of biomechanical movement performance in upper limb rehabilitation improve functional outcomes after stroke?
Ethics approval
NHS West of Scotland Research Ethics Committee 2, 15/06/2011, REC reference number: 11/AL/0260
Study design
Interventional single-blind single centre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Drug names
Primary outcome measures
Arm function as 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 as 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 trial start date
01/10/2011
Overall trial end date
01/04/2013
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
45
Participant 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
Recruitment start date
01/10/2011
Recruitment end date
01/04/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Strathclyde
Glasgow
G4 0NW
United Kingdom
Sponsor information
Organisation
University of Strathclyde (UK)
Sponsor details
Contracts Manager
c/o Louise McKean
Research & Knowledge Exchange Services
50 George Street
Glasgow
G1 1QE
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK) - Lifelong Health and Wellbeing (Phase 2), Ref number: G0900583, Grant ID: 91021
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary