Clinical trial NCT02801279: Development of Kinect-assisted Home-based Bilateral Arm Training Program for Cerebral Palsy
Official title: Development of Kinect-assisted Home-based Bilateral Arm Training Program for Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Cerebral Palsy
Occupational Therapy
Upper Limb Motor Training
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2016-06-15
Enrollment: 32
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the present study is to develop a long term cost-effectiveness (efficient protocol, playful context, and practical strategy) training program for school-age children with Cerebral Palsy. Also, evaluate efficacy of Kinect-assisted bilateral arm training program for children with Cerebral Palsy.


Eligibility criteria: The inclusion criteria of children with CP are:

1. diagnosed with congenital hemiplegic
2. no excessive muscle tone (Modified Ashworth Scale ≤ 3 at any joints of the upper limb)

The exclusion criteria of children with CP are:

1. have severe cognitive, visual, or auditory disorders according to medical documents, parental reports, and the examiner's clinical observation
2. have injections of botulinum toxin type A.

The inclusion criteria of typically developing children are:

1. absence of medical or developmental diseases which would affect physical and cognitive performances
2. having normal corrected vision
3. studying in regular education classroom in primary school for the 6-12 year-old children.

The exclusion criteria of typically developing children are:

(1) having score not within normal limits in BOTMP-short form

Primary outcomes:
measure: Performance change of Kinematic analysis
timeFrame: baseline, after 8 weeks, after 6 months
Secondary outcomes:
measure: Change of muscle strength
timeFrame: baseline, after 8 weeks, after 6 months
measure: Score change of Melbourne Assessment 2 (MA-2)
timeFrame: baseline, after 4 weeks, after 8 weeks, after 6 months
measure: Score change of Pediatric Motor Activity Log-Revised (PMAL-R)
timeFrame: baseline, after 4 weeks, after 8 weeks, after 6 months
measure: Score change of ABILHAND-Kids
timeFrame: baseline, after 4 weeks, after 8 weeks, after 6 months
measure: Score change of Test of Playfulness (ToP)
timeFrame: baseline, after 4 weeks, after 8 weeks, after 6 months
measure: Score change of Box and Block Test (BBT)
timeFrame: baseline, every week(week1 to week 8), after 4 weeks, after 8 weeks, after 6 months
measure: Score change of Engagement Questionnaire (EQ)
timeFrame: baseline, after 4 weeks, after 8 weeks, after 6 months
measure: Score change of Satisfactory Questionnaire (SQ)
timeFrame: baseline, after 4 weeks, after 8 weeks, after 6 months
measure: Score change of Building Tower Test (BTT)
timeFrame: baseline, every week(week1 to week 8), after 4 weeks, after 8 weeks, after 6 months
measure: Score change of String Beads Test (SBT)
timeFrame: baseline, every week(week1 to week 8), after 4 weeks, after 8 weeks, after 6 months
measure: Score change of Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2)
timeFrame: baseline, after 4 weeks, after 8 weeks, after 6 months
measure: Score change of Pediatric Evaluation of Disability Inventory (PEDI)
timeFrame: baseline, after 4 weeks, after 8 weeks, after 6 months
measure: Score change of Cerebral Palsy Quality of Life Questionnaire for Children (CPQOL)
timeFrame: baseline, after 4 weeks, after 8 weeks, after 6 months
measure: Score change of Parenting Stress Index-Short Form (PSI-short)
timeFrame: baseline, after 4 weeks, after 8 weeks, after 6 months
measure: Score change of Test of Visual Perceptual Skills
timeFrame: baseline, after 4 weeks, after 8 weeks, after 6 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Taiwan University, Department of Occupational Therapy
name: Hao-Ling Chen
role: PRINCIPAL_INVESTIGATOR
References: