Skip to main content
OpenTrials
Completed

NCT Number: NCT03229733

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Kinect

Device

Receive Kinect games training for 30 minutes. There are 3 sections for 1 week; the intervention period will be 8 weeks

Traditional occupational therapy

Behavioral

Patients will receive individually tailored conventional training consisting of the similar movement and dose by using the traditional equipment, such as climbing bar.

Primary outcomes

  1. Motor function assessed on Fugl-Meyer Assessment (FMA)

    Time frame: Change from baseline at 5 months

    The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.

Secondary outcomes

  1. The amount of movement assessed on Actigraph Assessment

    Time frame: Change from baseline at 2 months

    The outcome will be measured at 2 time points: 0 week, and 8 weeks after recruitment.

  2. The upper extremity motor ability assessed on Wolf Motor Function Test (WMFT)

    Time frame: Change from baseline at 5 months

    The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.

  3. The quality of movement and amount of use assessed on Motor Activity Log (MAL)

    Time frame: Change from baseline at 5 months

    The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.

  4. The instrumental activities of daily living assessed on Nottingham Extended Activities of Daily Living Scale (NEADL)

    Time frame: Change from baseline at 5 months

    The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.

  5. The relevant for upper-extremity function self-report questionnaire on Stroke Impact Scale (SIS)

    Time frame: Change from baseline at 5 months

    The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.

  6. Standing balance assessed on The Functional reach test (FR)

    Time frame: Change from baseline at 5 months

    The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.

  7. Muscle power assessed on Medical Research Council Scale (MRC)

    Time frame: Change from baseline at 5 months

    The outcome will be measured at 3 time points: 0 week, 8 weeks, and 5 months after recruitment.

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

Design and Evaluation the Feasibility, Effects of Kinect-based Computer Games for Rehabilitation Training of Upper Extremity Function in Patients With Chronic Stroke

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 25, 2017
Registry last updated
Jul 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.