Clinical trial NCT02364245: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Cerebral Palsy.
Upper Extremity
Kinect
Virtual reality
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2015-02-18
Enrollment: 13
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from Baseline in Melbourme Assessment Scales
timeFrame: Children will be assesed at 8 weeks and 16 weeks
Secondary outcomes:
measure: Change from Baseline in Quality of Upper Extremity Skills Test
timeFrame: Children will be assesed at 8 weeks and 16 weeks
measure: Change from Baseline in Motor-free perceptual assessment
timeFrame: Children will be assesed at 8 weeks and 16 weeks
measure: Change from Baseline in ABILHAND-kids
timeFrame: Children will be assesed at 8 weeks and 16 weeks
measure: Change from Baseline in Box and Block Test
timeFrame: Children will be assesed at 8 weeks and 16 weeks
measure: Change from Baseline in Cerebral Palsy Quality of Life for Children (CP QOL-Child) questionnaire
timeFrame: Children will be assesed at 8 weeks and 16 weeks
measure: Change from Baseline in Visual analogue scale
timeFrame: Children will be assesed at 8 weeks and 16 weeks
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Department of Rehabilitation, Chang Gung Memorial Hospital-Kaohsiung Medical Center, Kaohsiung, Taiwan
Study officials:
affiliation: Department of Rehabilitation, Chang Gung Memorial Hospital-Kaohsiung Medical Center, Kaohsiung, Taiwan
name: Jen-Wen Hung, MD
role: PRINCIPAL_INVESTIGATOR
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