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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
University of Nottingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Rehabilitation, Virtual Reality

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    December 15, 2015
    Last Updated
    December 22, 2015
    Sponsor
    University of Nottingham
    Collaborators
    Nottingham Trent University
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    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

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    A Low Cost Virtual Reality System for Home Based Rehabilitation of the Upper Limb Following Stroke

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