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Evaluation the Feasibility and Effects of Kinect-based Computer Games as UE Training Tool in Cerebral Palsy Children

Primary Purpose

Cerebral Palsy

Status

Completed

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

Kinect

Traditional OT(30 Mins)

Traditional OT(60 Mins)

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Cerebral Palsy., Upper Extremity, Kinect, Virtual reality

Eligibility Criteria

4 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Cerebral Palsy
4-12 years old
Cognition ability is good for evaluation and training
Affected side: Manual ability classification system(MACS) I-III

Exclusion Criteria:

Accept Upper Extremity surgery before recruiting
Accept Botox injunction three months before recruiting
Unstable Seizure

Sites / Locations

Department of Rehabilitation, Chang Gung Memorial Hospital-Kaohsiung Medical Center, Kaohsiung, Taiwan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Kinect

Traditional

Arm Description

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

The control group will receive traditional OT for 1 hour. There are 3 sections for 1 week; the intervention period will be 8 weeks.

Outcomes

Primary Outcome Measures

Change from Baseline in Melbourme Assessment Scales

Secondary Outcome Measures

Change from Baseline in Quality of Upper Extremity Skills Test

Change from Baseline in Motor-free perceptual assessment

Change from Baseline in ABILHAND-kids

Change from Baseline in Box and Block Test

Change from Baseline in Cerebral Palsy Quality of Life for Children (CP QOL-Child) questionnaire

Change from Baseline in Visual analogue scale

Full Information

NCT ID

NCT02364245

First Posted

January 26, 2015

Last Updated

August 1, 2016

Sponsor

Chang Gung Memorial Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02364245

Brief Title

Evaluation the Feasibility and Effects of Kinect-based Computer Games as UE Training Tool in Cerebral Palsy Children

Official Title

Design and Evaluation the Feasibility, Effects of Kinect-based Computer Games as Upper Extremity Training Tool in Children With Cerebral Palsy

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Completed

Study Start Date

November 2014 (undefined)

Primary Completion Date

July 2016 (Actual)

Study Completion Date

July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chang Gung Memorial Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to design and evaluation the feasibility, effects of Kinect-based Computer Games as Upper Extremity Training Tool in Children with Cerebral Palsy.

Detailed Description

Background Children with cerebral palsy (CP) usually have various limitations in function of their upper limbs. Upper limbs function training is one of the important issues in CP rehabilitation. There is a growing interest in rehabilitation specialists to integrate commercialized interactive computer play into rehabilitation programs. According to the literature research, commercialized interactive computer play could improve speed and quality of movement, for hand or upper limb function, the results were mixed. The investigators think the interactive computer play could be feasible in upper limb training among children with CP. However, the investigators should integrate the rehabilitation training concept to the computer playing in order to get better outcome from such training. The electronic experts and rehabilitation experts should work together to reach the goal. Therefore, the aims of this study are 1.to design Kinect computer games as the rehabilitation training tool for upper limbs of children with CP, 2. to assess the feasibility and effects of the Kinect computer games. Methods The investigators will spend around nine months to design the computer games. The investigators will search from the internet to download the computer games which are with no copy-right issue. The investigators will use Kinect sensor to catch the child's motion. The rehabilitation team will choose several upper limb motions which are common used in training for children with CP. Then Professor Chang's team will modify the software design to make those target motions to be the game control actions.When a prototype game is created, the investigators will invite two to four children with CP to pilot test the game. The game design will be completed till children and therapists satisfy the design. Within one year and three months the investigators will do a randomized control trial to compare the effects between the Kinect games and traditional occupational therapy (OT) in the upper limb function of children in CP. The investigators will recruit 30 children and randomize them into two groups. In each intervention section the intervention group will receive computer games training for 30 minutes and 30 minutes traditional OT. The control group will receive traditional OT for 1 hour. There are 3 sections for 1 week; the intervention period will be 8 weeks. Statistic methods Inter-group differences in baseline characteristics were evaluated using an independent t tests or Wilcoxon rank sum tests or χ2 analysis. Analysis of variance with repeated measures was used to determine the effects of intervention on each dependent variable. Model effects were group, time, and their interaction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cerebral Palsy

Keywords

Cerebral Palsy., Upper Extremity, Kinect, Virtual reality

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Kinect

Arm Type

Experimental

Arm Description

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

Arm Title

Traditional

Arm Type

Placebo Comparator

Arm Description

The control group will receive traditional OT for 1 hour. There are 3 sections for 1 week; the intervention period will be 8 weeks.

Intervention Type

Device

Intervention Name(s)

Kinect

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Traditional OT(30 Mins)

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Traditional OT(60 Mins)

Intervention Description

Receive Traditional Occupational Therapy training for 60 minutes. There are 3 sections for 1 week; the intervention period will be 8 weeks.

Primary Outcome Measure Information:

Title

Change from Baseline in Melbourme Assessment Scales

Time Frame