Clinical trial NCT02808195: Comparative Effectiveness of a Kinect-based Unilateral Arm Training System vs Constraint-Induced Therapy for Children With Cerebral Palsy
Official title: Comparative Effectiveness of a Kinect-based Unilateral Arm Training System vs Constraint-Induced Therapy for Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Cerebral Palsy
Neurological Rehabilitation
Upper Extremity
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2016-06-21
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aims of the present study is to evaluate the effectiveness of Kinect-based upper limb motor rehabilitation system (ULMTS) program on motor performance and functional outcomes.

Detailed description: The specific aims of this study project will be:

To compare the effectiveness of intervention groups using Kinect-based ULMTS with constraint-induced therapy on motor improvement in children with hemiplegic CP. The investigators hypothesize that motor improvement in using Kinect-based ULMTS will be comparable to constraint-induced therapy.

Eligibility criteria: Inclusion criteria are:

1. 3-16 years old
2. diagnosed with congenital hemiplegic or CP with one more affected side
3. considerable nonuse of the affected upper limb.

Exclusion criteria are:

1. no excessive muscle tone (Modified Ashworth Scale ≤ 2 at any joints of the upper limb) before beginning treatment (Bohannon \& Smith, 1987)
2. no severe cognitive, visual, or auditory disorders according to medical documents, parental reports, and the examiner's clinical observation
3. no injections of botulinum toxin type A or operations on the upper limb within 6 months.

Primary outcomes:
measure: Performance Change assessed by Kinematic analysis
timeFrame: baseline, 2 months and 6 months
Secondary outcomes:
measure: score change of Bruininks-Oseretsky Test of Motor Proficiency Second Edition (BOT-2)
timeFrame: baseline, 1 months, 2 months and 6 months
measure: score change of Melbourne Assessment 2 (MA2)
timeFrame: baseline, 1 months, 2 months and 6 months
measure: score change of Pediatric Motor Activity Log-Revised (PMAL-R)
timeFrame: baseline, 1 months, 2 months and 6 months
measure: score change of ABILHAND-kids
timeFrame: baseline, 1 months, 2 months and 6 months
measure: score change of Functional Independence Measures for children (WeeFIM)
timeFrame: baseline, 1 months, 2 months and 6 months
measure: score change of Pediatric evaluation of disability inventory (PEDI)
timeFrame: baseline, 1 months, 2 months and 6 months
measure: score change of Cerebral Palsy Quality of Life Questionnaire for Children (CP-QOL)
timeFrame: baseline, 1 months, 2 months and 6 months
measure: score change of Test of Visual Perceptual Skills-3rd (TVPS-3)
timeFrame: baseline, 1 months, 2 months and 6 months
measure: score change of Test of Playfulness (TOP)
timeFrame: baseline, 1 months, 2 months and 6 months
measure: score change of Engagement Questionnaire (EQ)
timeFrame: baseline, 1 months, 2 months and 6 months
measure: score change of Clint Satisfaction Questionnaire (CSQ)
timeFrame: baseline, 1 months, 2 months and 6 months
measure: score change of Parenting Stress Index-Short Form (PSI-SF)
timeFrame: baseline, 1 months, 2 months and 6 months
measure: Muscle strength
timeFrame: baseline, 2 months and 6 months
measure: score change of Building Tower Test
timeFrame: baseline, 1 months, 2 months and 6 months
measure: score change of Test of String Beads
timeFrame: baseline, 1 months, 2 months and 6 months
measure: score change of Box and Block Test
timeFrame: baseline, 1 months, 2 months and 6 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University
name: Hao-Ling Chen
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen HL, Lin SY, Yeh CF, Chen RY, Tang HH, Ruan SJ, Wang TN. Development and Feasibility of a Kinect-Based Constraint-Induced Therapy Program in the Home Setting for Children With Unilateral Cerebral Palsy. Front Bioeng Biotechnol. 2021 Oct 26;9:755506. doi: 10.3389/fbioe.2021.755506. eCollection 2021.