Condition category
Circulatory System
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

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

Trial website

Contact information



Primary contact

Miss Lucy Jones


Contact details

Department of Bioengineering
Wolfson Building
University of Strathclyde
106 Rottenrow
G4 0NW
United Kingdom
+44 (0) 141 548 3028

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

The impact of augmented visual feedback in upper limb rehabilitation in sub-acute stroke: a pilot randomised controlled trial


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


Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet




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



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


Overall trial end date


Reason abandoned


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


Age group




Target number of participants


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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

University of Strathclyde
G4 0NW
United Kingdom

Sponsor information


University of Strathclyde (UK)

Sponsor details

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

Sponsor type




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


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

Publication citations

Additional files

Editorial Notes