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

NCT ID: NCT02364245

Last Updated: 2016-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2016-07-31

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.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Kinect

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.

Group Type: EXPERIMENTAL

Kinect

Intervention Type: DEVICE

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

Traditional OT(30 Mins)

Intervention Type: OTHER

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

Traditional

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

Group Type: PLACEBO_COMPARATOR

Traditional OT(60 Mins)

Intervention Type: OTHER

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

Interventions

Kinect

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

Intervention Type: DEVICE

Traditional OT(30 Mins)

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

Traditional OT(60 Mins)

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jen-Wen Hung, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Kaohsiung, Taiwan, Taiwan

Countries

Taiwan

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Other Identifiers

CMRPG8D0941

Identifier Type: -

Identifier Source: org_study_id