A Low Cost Virtual Reality System for Home Based Rehabilitation of the Upper Limb Following Stroke (WiiSTAR)
Primary Purpose
Stroke
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Virtual glove
Sponsored by

About this trial
This is an interventional treatment trial for Stroke focused on measuring Stroke, Rehabilitation, Virtual Reality
Eligibility Criteria
Inclusion Criteria:
- confirmed diagnosis of stroke, no longer receiving any other intensive rehabilitation (intermediate care, early supported discharge) still experiencing residual upper limb dysfunction.
Exclusion Criteria:
- no detectable movement in the upper limb; premorbid disability in upper limb function; severe symptomatic arm or shoulder pain; severe visual impairments; other neurological illnesses such as head injury or multiple sclerosis; unstable medical condition; psychiatric illness; epilepsy triggered by screen images; cardiac pacemaker; unable to tolerate sitting in a chair for 30 minutes or follow a two stage command or living in a care home.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
The virtual glove in their homes for a period of 8 weeks and advised to try to build up to using the system for a maximum of 20 minutes 3 times a day for 8 weeks.
Usual care
Outcomes
Primary Outcome Measures
Wolf Motor Function Test change from baseline at 4 weeks and 8 weeks
Change from baseline to 4 weeks and from baseline to 8 weeks in the Wolf Motor Function Test
Secondary Outcome Measures
Nine-Hole Peg Test
Full Information
NCT ID
NCT02637791
First Posted
December 15, 2015
Last Updated
December 22, 2015
Sponsor
University of Nottingham
Collaborators
Nottingham Trent University
1. Study Identification
Unique Protocol Identification Number
NCT02637791
Brief Title
A Low Cost Virtual Reality System for Home Based Rehabilitation of the Upper Limb Following Stroke
Acronym
WiiSTAR
Official Title
A Low Cost Virtual Reality System for Home Based Rehabilitation of the Upper Limb Following Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nottingham
Collaborators
Nottingham Trent University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Stroke is the third most common cause of mortality and the leading cause of long term disability worldwide with over 900,000 people living in England who have had a stroke. 75% of survivors regain their ability to walk again, however it is estimated that between 55 and 75% fail to regain satisfactory use of their impaired arm. This limits the person's independence, ability to care for themselves and reduces their quality of life. Research indicates that for optimal recovery, high levels of rehabilitation are required yet current provision often fails to meet the required levels of intensity and duration of therapy.
In conjunction with stroke patients, their families and therapists, the team developed a low cost system (the virtual glove) to encourage stroke survivors to practice arm exercises at home. The system tracks infrared light emitting diodes (LEDs) positioned on the fingers turning the hand into a game controller to play games that encourage the movements of reach, grasp and release that underlie activities of daily living.
Before examining its effectiveness, the purpose of the registered study is to determine how feasible a large trial would be in terms of whether sufficient participants could be recruited, whether they would use the glove and whether outcome measures could be collected.
Patients will be recruited if they are aged 18 years or over, are recovering from a stroke, no longer receive any other intensive rehabilitation but still experiencing difficulty using their arm. After baseline measures are collected they will be randomly allocated to either the intervention group or a control group. The intervention group will have the virtual glove and games at home for a period of eight weeks and be advised to use the equipment for 20 minutes, three times a day. The control group will continue to have whatever care they are already receiving but no new interventions.
Outcome measures will be collected at baseline, four weeks and after the equipment has been removed from their home. Outcome measures will include tests of arm function as well participant reports of how often they are using their affected arm and how easy they find activities of daily living. The therapists collecting the outcome measures will not know to which group the participants have been allocated.
Once all outcome measures are collected the two groups will be compared on how much their final outcome measures differ from those collected at baseline.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Rehabilitation, Virtual Reality
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
The virtual glove in their homes for a period of 8 weeks and advised to try to build up to using the system for a maximum of 20 minutes 3 times a day for 8 weeks.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Device
Intervention Name(s)
Virtual glove
Intervention Description
The intervention (the virtual glove) consists of a hand-mounted power unit, with four infra- red light emitting diodes (LEDs) mounted on the user's finger tips. The LEDs are tracked using one or two Nintendo Wii motes mounted by the computer screen on which the games are displayed to translate the location of the user's hand, fingers and thumb in 3D space. Three games have been produced especially for the project with the help of therapists and stroke patients. In order to play them, users have to perform the movements of reach to grasp, grasp and release, pronation and supination that are necessary to effect many activities of daily living.
Primary Outcome Measure Information:
Title
Wolf Motor Function Test change from baseline at 4 weeks and 8 weeks
Description
Change from baseline to 4 weeks and from baseline to 8 weeks in the Wolf Motor Function Test
Time Frame
Baseline, 4 weeks and 8 weeks
Secondary Outcome Measure Information:
Title
Nine-Hole Peg Test
Time Frame
Baseline, 4 weeks and 8 weeks
Other Pre-specified Outcome Measures:
Title
Motor Activity Log
Time Frame
Baseline, 4 weeks and 8 weeks
Title
Nottingham Extended Activities of Daily Living Scale
Time Frame
Baseline, 4 weeks and 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
confirmed diagnosis of stroke, no longer receiving any other intensive rehabilitation (intermediate care, early supported discharge) still experiencing residual upper limb dysfunction.
Exclusion Criteria:
no detectable movement in the upper limb; premorbid disability in upper limb function; severe symptomatic arm or shoulder pain; severe visual impairments; other neurological illnesses such as head injury or multiple sclerosis; unstable medical condition; psychiatric illness; epilepsy triggered by screen images; cardiac pacemaker; unable to tolerate sitting in a chair for 30 minutes or follow a two stage command or living in a care home.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marion Walker, PhD
Organizational Affiliation
University of Nottingham
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Low Cost Virtual Reality System for Home Based Rehabilitation of the Upper Limb Following Stroke
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