Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2026-01-07 @ 5:29 PM
Study NCT ID:
NCT03229733
Status:
COMPLETED
Last Update Posted:
2018-07-18
First Post:
2017-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Design and Evaluation the Effects of Kinect-based Computer Games for U/E Training in Chronic Stroke Patients
Sponsor:
Chang Gung Memorial Hospital
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: