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Completed

NCT Number: NCT02364245

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

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.

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Key information

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Kaohsiung, Taiwan, 833

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Kinect

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)

Other

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

Traditional OT(60 Mins)

Other

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

Primary outcomes

  1. Change from Baseline in Melbourme Assessment Scales

    Time frame: Children will be assesed at 8 weeks and 16 weeks

Secondary outcomes

  1. Change from Baseline in Quality of Upper Extremity Skills Test

    Time frame: Children will be assesed at 8 weeks and 16 weeks

  2. Change from Baseline in Motor-free perceptual assessment

    Time frame: Children will be assesed at 8 weeks and 16 weeks

  3. Change from Baseline in ABILHAND-kids

    Time frame: Children will be assesed at 8 weeks and 16 weeks

  4. Change from Baseline in Box and Block Test

    Time frame: Children will be assesed at 8 weeks and 16 weeks

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

    Time frame: Children will be assesed at 8 weeks and 16 weeks

  6. Change from Baseline in Visual analogue scale

    Time frame: Children will be assesed at 8 weeks and 16 weeks

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 as Upper Extremity Training Tool in Children With Cerebral Palsy

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 18, 2015
Registry last updated
Aug 2, 2016

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.

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