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Comparative Effectiveness of a Kinect-based Unilateral Arm Training System vs Constraint-Induced Therapy for Children With Cerebral Palsy

Comparative Effectiveness of a Kinect-based Unilateral Arm Training System vs Constraint-Induced Therapy for Children With Cerebral Palsy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02808195
Enrollment
60
Registered
2016-06-21
Start date
2016-08-31
Completion date
2024-03-14
Last updated
2024-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy

Keywords

Cerebral Palsy, Neurological Rehabilitation, Upper Extremity

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.

Interventions

OTHERConstraint-induced therapy
OTHERkinect-based constraint-induced therapy

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
3 Years to 16 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Performance Change assessed by Kinematic analysisbaseline, 2 months and 6 monthsKinematic analysis including measuring the parameters of endpoint control, joint recruitment and inter-joint coordination, and trunk involvement.

Secondary

MeasureTime frameDescription
score change of Melbourne Assessment 2 (MA2)baseline, 1 months, 2 months and 6 months
score change of Pediatric Motor Activity Log-Revised (PMAL-R)baseline, 1 months, 2 months and 6 months
score change of ABILHAND-kidsbaseline, 1 months, 2 months and 6 months
score change of Functional Independence Measures for children (WeeFIM)baseline, 1 months, 2 months and 6 months
score change of Pediatric evaluation of disability inventory (PEDI)baseline, 1 months, 2 months and 6 months
score change of Cerebral Palsy Quality of Life Questionnaire for Children (CP-QOL)baseline, 1 months, 2 months and 6 months
score change of Test of Visual Perceptual Skills-3rd (TVPS-3)baseline, 1 months, 2 months and 6 months
score change of Bruininks-Oseretsky Test of Motor Proficiency Second Edition (BOT-2)baseline, 1 months, 2 months and 6 months
score change of Engagement Questionnaire (EQ)baseline, 1 months, 2 months and 6 months
score change of Clint Satisfaction Questionnaire (CSQ)baseline, 1 months, 2 months and 6 months
score change of Parenting Stress Index-Short Form (PSI-SF)baseline, 1 months, 2 months and 6 months
Muscle strengthbaseline, 2 months and 6 monthsmeasured by electromyography
score change of Building Tower Testbaseline, 1 months, 2 months and 6 months
score change of Test of String Beadsbaseline, 1 months, 2 months and 6 months
score change of Box and Block Testbaseline, 1 months, 2 months and 6 months
score change of Test of Playfulness (TOP)baseline, 1 months, 2 months and 6 months

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026