search
Back to results

Design and Evaluation the Effects of Kinect-based Computer Games for U/E Training in Chronic Stroke Patients

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Kinect
Traditional occupational therapy
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Kinect, Rehabilitation, Upper limbs

Eligibility Criteria

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

Inclusion Criteria:

  • First ever ischemic or hemorrhagic stroke or former stroke without any significant residual motor impairment
  • 3 months post stroke
  • Impaired arm motor function at Brunnstrom stage 3-5
  • Age 18 years or older

Exclusion Criteria:

  • severe cognitive impairment defined as < 20 on Mini Mental State Examination
  • visual disorders or neglect limiting the ability to comply with treatment regimen
  • orthopedic problem or other neurological diagnosis that makes the UE dysfunction.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Experimental group

    Control group

    Arm Description

    Patients randomized to the experimental group participate in exergames training with Kinect. The supervised OT chooses different games according to the patient's needs and abilities. During therapy patients are at sitting position. The game program will be adjusted when patients got improvement. After 30 minutes of exergames training, participants will receive a 30-minutes of traditional occupational therapy.

    Patients in the control group will receive individually tailored traditional occupational therapy consisting of the similar movement and dose as the experimental group doing by using the traditional equipment, such as climbing bar.

    Outcomes

    Primary Outcome Measures

    Motor function assessed on Fugl-Meyer Assessment (FMA)
    The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.

    Secondary Outcome Measures

    The amount of movement assessed on Actigraph Assessment
    The outcome will be measured at 2 time points: 0 week, and 8 weeks after recruitment.
    The upper extremity motor ability assessed on Wolf Motor Function Test (WMFT)
    The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.
    The quality of movement and amount of use assessed on Motor Activity Log (MAL)
    The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.
    The instrumental activities of daily living assessed on Nottingham Extended Activities of Daily Living Scale (NEADL)
    The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.
    The relevant for upper-extremity function self-report questionnaire on Stroke Impact Scale (SIS)
    The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.
    Standing balance assessed on The Functional reach test (FR)
    The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.
    Muscle power assessed on Medical Research Council Scale (MRC)
    The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.

    Full Information

    First Posted
    July 23, 2017
    Last Updated
    July 17, 2018
    Sponsor
    Chang Gung Memorial Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03229733
    Brief Title
    Design and Evaluation the Effects of Kinect-based Computer Games for U/E Training in Chronic Stroke Patients
    Official Title
    Design and Evaluation the Feasibility, Effects of Kinect-based Computer Games for Rehabilitation Training of Upper Extremity Function in Patients With Chronic Stroke
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2015 (undefined)
    Primary Completion Date
    December 2017 (Actual)
    Study Completion Date
    December 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Chang Gung Memorial Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aims of this study are to (i) develop exergames by using Kinect system for training UE function in patient with stroke; and (ii) to test the game's feasibility and effects in a group of patient with chronic stroke.
    Detailed Description
    Exercise based computer games can facilitate high volume complex task practice, enhance feedback of movement and increase motivation of participants. Those effects are difficult to achieve with standard rehabilitation therapy. The Kinect system is a camera-based controller which a player can use to directly control a game through body movement without the need for handheld controllers. Using Kinect to capture movement is a feasible way to help patients who have difficulties to hold controllers to play exergames. Scratch 2.0 is a programming language for kids from the MIT Media Laboratory. It is easy to use for game designing. Kinect2Scratch allows data from the Microsoft Kinect controller to be sent to Scratch, This means that game programs can be designed with motion control. The aims of this study were to i) develop exergames by using Scratch and Kinect system for training upper extremity function in patient with stroke; and ii) to test the game's feasibility and effects in a group of patient with chronic stroke. This program will be done within two years. During the first year, investigators will design several exergames which are suitable for training upper extremity function in patient with stroke. Investigators will have several experts meetings, involved by physiatrists, occupational therapists and engineers to design the game. When a prototype game is created, investigators will invite two to four patients with stroke to pilot test the game. The game design will be completed till patients and therapists satisfy the design. During the 2nd year, investigators will test the feasibility and effects of the exergames by doing a pilot randomized control trial. Investigators will recruit 60 patients with chronic stroke who are admitted to a rehabilitation ward for outpatient rehabilitation, and will randomize participants to experiment or control group. All participants will receive PT and OT training as routine. The additional intervention either exergames or conventional OT will be delivered for 8 weeks with 3 training sessions/week of up to 30 minutes.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke
    Keywords
    Stroke, Kinect, Rehabilitation, Upper limbs

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental group
    Arm Type
    Experimental
    Arm Description
    Patients randomized to the experimental group participate in exergames training with Kinect. The supervised OT chooses different games according to the patient's needs and abilities. During therapy patients are at sitting position. The game program will be adjusted when patients got improvement. After 30 minutes of exergames training, participants will receive a 30-minutes of traditional occupational therapy.
    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    Patients in the control group will receive individually tailored traditional occupational therapy consisting of the similar movement and dose as the experimental group doing by using the traditional equipment, such as climbing bar.
    Intervention Type
    Device
    Intervention Name(s)
    Kinect
    Intervention Description
    Receive Kinect games training for 30 minutes. There are 3 sections for 1 week; the intervention period will be 8 weeks
    Intervention Type
    Behavioral
    Intervention Name(s)
    Traditional occupational therapy
    Intervention Description
    Patients will receive individually tailored conventional training consisting of the similar movement and dose by using the traditional equipment, such as climbing bar.
    Primary Outcome Measure Information:
    Title
    Motor function assessed on Fugl-Meyer Assessment (FMA)
    Description
    The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.
    Time Frame
    Change from baseline at 5 months
    Secondary Outcome Measure Information:
    Title
    The amount of movement assessed on Actigraph Assessment
    Description
    The outcome will be measured at 2 time points: 0 week, and 8 weeks after recruitment.
    Time Frame
    Change from baseline at 2 months
    Title
    The upper extremity motor ability assessed on Wolf Motor Function Test (WMFT)
    Description
    The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.
    Time Frame
    Change from baseline at 5 months
    Title
    The quality of movement and amount of use assessed on Motor Activity Log (MAL)
    Description
    The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.
    Time Frame
    Change from baseline at 5 months
    Title
    The instrumental activities of daily living assessed on Nottingham Extended Activities of Daily Living Scale (NEADL)
    Description
    The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.
    Time Frame
    Change from baseline at 5 months
    Title
    The relevant for upper-extremity function self-report questionnaire on Stroke Impact Scale (SIS)
    Description
    The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.
    Time Frame
    Change from baseline at 5 months
    Title
    Standing balance assessed on The Functional reach test (FR)
    Description
    The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.
    Time Frame
    Change from baseline at 5 months
    Title
    Muscle power assessed on Medical Research Council Scale (MRC)
    Description
    The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.
    Time Frame
    Change from baseline at 5 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: First ever ischemic or hemorrhagic stroke or former stroke without any significant residual motor impairment 3 months post stroke Impaired arm motor function at Brunnstrom stage 3-5 Age 18 years or older Exclusion Criteria: severe cognitive impairment defined as < 20 on Mini Mental State Examination visual disorders or neglect limiting the ability to comply with treatment regimen orthopedic problem or other neurological diagnosis that makes the UE dysfunction.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jen-Wen Hung
    Organizational Affiliation
    Chang Gung Memorial Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    25297823
    Citation
    Noorkoiv M, Rodgers H, Price CI. Accelerometer measurement of upper extremity movement after stroke: a systematic review of clinical studies. J Neuroeng Rehabil. 2014 Oct 9;11:144. doi: 10.1186/1743-0003-11-144.
    Results Reference
    result
    PubMed Identifier
    25265612
    Citation
    Adams RJ, Lichter MD, Krepkovich ET, Ellington A, White M, Diamond PT. Assessing upper extremity motor function in practice of virtual activities of daily living. IEEE Trans Neural Syst Rehabil Eng. 2015 Mar;23(2):287-96. doi: 10.1109/TNSRE.2014.2360149. Epub 2014 Sep 24.
    Results Reference
    result
    PubMed Identifier
    11441212
    Citation
    Wolf SL, Catlin PA, Ellis M, Archer AL, Morgan B, Piacentino A. Assessing Wolf motor function test as outcome measure for research in patients after stroke. Stroke. 2001 Jul;32(7):1635-9. doi: 10.1161/01.str.32.7.1635.
    Results Reference
    result

    Learn more about this trial

    Design and Evaluation the Effects of Kinect-based Computer Games for U/E Training in Chronic Stroke Patients

    We'll reach out to this number within 24 hrs