Clinical trial NCT02808156: Effectiveness of Unilateral Versus Bilateral Intensive Training in Children With Cerebral Palsy
Official title: Effectiveness of Unilateral Versus Bilateral Intensive Training in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Keywords: Cerebral Palsy,
Upper limb neurorehabilitation
Upper Extremity
Neurological Rehabilitation
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: This 3-year research project aims to investigate and compare the immediate and long-term treatment effectiveness as well as motor improving curve and potential predictors of the unimanual intensive training and bimanual intensive training protocols with an equivalent intervention period in children with hemiplegic CP and children with CP with apparently one side affected. In addition, based on the ICF-CY model, comprehensive outcome measures including motor functions as well as psychological functions will be included.


Eligibility criteria: The inclusion criteria of this study are:

1. aged between 3 and 16 years
2. diagnosed with congenital hemiplegic or children with CP with one more affected side; (3) apparently disuse phenomenon of the more affected hand at spontaneous contexts

Participants will be exclude for:

1. excessive muscle tone (Modified Ashworth Scale ≤ 2 at any joints of the upper limb) before beginning treatment (Bohannon \& Smith, 1987)
2. severe cognitive, visual, or auditory disorders according to medical documents, parental reports, and the examiner's clinical observation
3. injections of botulinum toxin type A or operations on the UE within 6 months

Primary outcomes:
measure: Changes from Melbourne Assessment 2 (MA-2)
timeFrame: baseline, week 4, week 8, week 24
measure: Changes from Pediatric Motor Activity Log-Revised (PMAL-R)
timeFrame: baseline, week 4, week 8, week 24
measure: Changes from ABILHAND-Kids
timeFrame: baseline, week 4, week 8, week 24
measure: Changes from Test of Playfulness (ToP)
timeFrame: week 1, week 4, week 5, week 8
measure: Changes from Box and Block Test (BBT)
timeFrame: weekly test (from baseline to week 8)
measure: Changes from Engagement Questionnaire (EQ)
timeFrame: weekly test (from week 1 to week 8)
measure: Changes from Satisfactory Questionnaire (SQ)
timeFrame: baseline, week 4, week 8, week 24
measure: Changes from Building Tower Test (BTT)
timeFrame: weekly test (from baseline to week 8)
measure: Changes from String Beads Test (SBT)
timeFrame: weekly test (from baseline to week 8)
measure: Changes from Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2)
timeFrame: baseline, week 4, week 8, week 24
measure: Performance changes assessed by Kinematics Analysis
timeFrame: baseline, week 8, week 24
measure: Changes from muscle strength
timeFrame: baseline, week 8, week 24
Secondary outcomes:
measure: Changes from Pediatric Evaluation of Disability Inventory (PEDI)
timeFrame: baseline, week 4, week 8, week 24
measure: Changes from Cerebral Palsy Quality of Life Questionnaire for Children (CPQOL)
timeFrame: baseline, week 4, week 8, week 24
measure: Changes from Parenting Stress Index-Short Form (PSI-short)
timeFrame: baseline, week 4, week 8, week 24
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
state: Zhongzheng District
Study officials:
affiliation: Department of Occupational Therapy, School of Medicine, National Taiwan University
name: Tien-Ni Wang
role: PRINCIPAL_INVESTIGATOR
References: