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Rehabilitation Effects on Balance With Kinect for Xbox Virtual Reality Games

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Virtual reality
Standard treatment
Sponsored by
Taipei Medical University Shuang Ho Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Chronic stroke person (onset>6m)
  • Could understand game command
  • Could stand unsupported or stand with advice at least 15 minute
  • Brunnstrom stage of LE ≥Ⅲ

Exclusion Criteria:

  • Age >75 years old or <20 years old
  • Severe visual or auditory impairment
  • Modified Ashworth Scale of LE ≥ 3
  • The Montreal Cognitive Assessment<16
  • Other medication(neural, cardio-pulmonary, musculoskeletal) that influence motor command during the game

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Virtual reality group

    Standard treatment only group

    Arm Description

    45 min standard treatment plus 45 min virtual reality balance training used by Kinect for Xbox game. Game choosed based on motor learning principle. Training task such as reach or stepping in various direction, squat, stand up, upper trunk forward or lateral bench.

    90 min standard treatment. Depended on patient's ability, principle used by motor learning, sensory process, motor control, task oriented training, symmetry w't bearing.

    Outcomes

    Primary Outcome Measures

    Berg Balance Scale
    balance function

    Secondary Outcome Measures

    Modified barthel index
    Activity of daily live ability
    Activities-specific Balance Confidence scale
    balance confidence
    Stroke Impact Scale
    quality of life
    Modified Physical Activity Enjoyment Scale
    pleasure scale
    Adverse event times
    Force plate
    balance function for Weight bearing symmetry and dynamic standing balance
    Functional reach test
    balance function
    Timed up and go-cognition
    balance function

    Full Information

    First Posted
    March 21, 2016
    Last Updated
    April 11, 2016
    Sponsor
    Taipei Medical University Shuang Ho Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02735265
    Brief Title
    Rehabilitation Effects on Balance With Kinect for Xbox Virtual Reality Games
    Official Title
    Evaluation of the Rehabilitation Effects on Balance With Kinect for Xbox Virtual Reality Games for Patients With Stroke
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2015 (undefined)
    Primary Completion Date
    February 2016 (Actual)
    Study Completion Date
    February 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Taipei Medical University Shuang Ho Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Virtual reality balance training has already been used in stroke rehabilitation, and previous studies supported that could improve balance ability. Although the treatment effects were supported in studies, there are still limitations in clinical intervention and the study power is not enough. Study will use Kinect for Xbox games for balance intervention. Investigators will recruit 60 patients with chronic stroke from Shung-ho hospital clinical rehabilitation and randomly assign participants to "standard treatment plus virtual reality group" (N=30) and "standard treatment only group" (N=30). There are total 12 sessions (2 times weekly) for both groups. Investigators will assess subjects' ability for 3 times (pre- and post-intervention, follow up in post 3 month).Investigators will also record the pleasure scale and adverse event after every training session. Hypothesis is that Kinect for Xbox intervention can significantly improve subjects' balance ability, confidence of balance, ADL, and QOL compared to the conventional rehabilitation. It may help to develop a new clinical model of virtual reality training for patients with chronic stroke.
    Detailed Description
    Many stroke survivors suffered postural and balance problems. Decreased mobility limits their daily life activities. Virtual reality balance training has already been used in stroke rehabilitation, and previous studies supported that could improve balance ability. The mechanism is multi-sensory feedback and repeated practices that could facilitate motor learning and brain neuroplasticity. Compared to conventional rehabilitation, VR rehabilitation could increase subjects' motivation and pleasure. Although the treatment effects were supported in studies, there are still limitations in clinical intervention and the study power is not enough. The study will use Kinect for Xbox games for balance intervention. Kinect for Xbox doesn't need additional controller held by subjects and can detect the movement in real time to give subjects visual and auditory feedback immediately. Investigators will recruit 60 patients with chronic stroke from Shung-ho hospital clinical rehabilitation and randomly assign them to "standard treatment plus virtual reality group" (N=30) and "standard treatment only group" (N=30). There are total 12 sessions (2 times weekly) for both groups. Investigators will assess subjects' ability for 3 times (pre- and post-intervention, follow up in post 3 month). The outcome measures include Force plate, Functional reach test, Berg Balance Scale, Time up and go for balance evaluations, Modified barthel index for ADL ability, Activities-specific Balance Confidence scale for balance confidence, and Stroke Impact Scale for quality of life. Investigators will also record the pleasure scale and adverse event after every training session. Collected data will be analyzed with repeated measures 2-way analysis of variance (ANOVA), Turkey test post hoc and independent T sample test. Hypothesis is that Kinect for Xbox intervention can significantly improve subjects' balance ability, confidence of balance, ADL, and QOL compared to the conventional rehabilitation. It may help to develop a new clinical model of virtual reality training for patients with chronic stroke.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke
    Keywords
    Rehabilitation, Virtual reality

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Virtual reality group
    Arm Type
    Experimental
    Arm Description
    45 min standard treatment plus 45 min virtual reality balance training used by Kinect for Xbox game. Game choosed based on motor learning principle. Training task such as reach or stepping in various direction, squat, stand up, upper trunk forward or lateral bench.
    Arm Title
    Standard treatment only group
    Arm Type
    Active Comparator
    Arm Description
    90 min standard treatment. Depended on patient's ability, principle used by motor learning, sensory process, motor control, task oriented training, symmetry w't bearing.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Virtual reality
    Intervention Description
    12 training sessions (90 minutes a time, 2 times a week) IG:45 minute of Kinect for Xbox games and 45 minute of standard treatment.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Standard treatment
    Intervention Description
    CG: 90 minute of standard treatment. 12 training sessions (90 minutes a time, 2 times a week)
    Primary Outcome Measure Information:
    Title
    Berg Balance Scale
    Description
    balance function
    Time Frame
    Change from Baseline at 6 weeks and 3 month follow up
    Secondary Outcome Measure Information:
    Title
    Modified barthel index
    Description
    Activity of daily live ability
    Time Frame
    Change from Baseline at 6 weeks and 3 month follow up
    Title
    Activities-specific Balance Confidence scale
    Description
    balance confidence
    Time Frame
    Change from Baseline at 6 weeks and 3 month follow up
    Title
    Stroke Impact Scale
    Description
    quality of life
    Time Frame
    Change from Baseline at 6 weeks and 3 month follow up
    Title
    Modified Physical Activity Enjoyment Scale
    Description
    pleasure scale
    Time Frame
    Every training session during 6 weeks (total 12 sessions (2 times weekly))
    Title
    Adverse event times
    Time Frame
    Every training session during 6 weeks (total 12 sessions (2 times weekly))
    Title
    Force plate
    Description
    balance function for Weight bearing symmetry and dynamic standing balance
    Time Frame
    Change from Baseline at 6 weeks and 3 month follow up
    Title
    Functional reach test
    Description
    balance function
    Time Frame
    Change from Baseline at 6 weeks and 3 month follow up
    Title
    Timed up and go-cognition
    Description
    balance function
    Time Frame
    Change from Baseline at 6 weeks and 3 month follow up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Chronic stroke person (onset>6m) Could understand game command Could stand unsupported or stand with advice at least 15 minute Brunnstrom stage of LE ≥Ⅲ Exclusion Criteria: Age >75 years old or <20 years old Severe visual or auditory impairment Modified Ashworth Scale of LE ≥ 3 The Montreal Cognitive Assessment<16 Other medication(neural, cardio-pulmonary, musculoskeletal) that influence motor command during the game
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hsinchieh Lee, master
    Organizational Affiliation
    Taipei Medical University, Taiwan, R.O.C.
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
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