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Effectiveness of Unilateral Versus Bilateral Intensive Training in Children With Cerebral Palsy

Effectiveness of Unilateral Versus Bilateral Intensive Training in Children With Cerebral Palsy

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02808156
Enrollment
60
Registered
2016-06-21
Start date
2016-06-30
Completion date
2024-12-31
Last updated
2024-03-12

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,, Upper limb neurorehabilitation, Upper Extremity, Neurological Rehabilitation

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.

Interventions

OTHERunilateral upper limbs intensive training

The unimanual intensive training group focuses on the training of the more affected arm and restraint the less affected arm.

OTHERbilateral upper limbs intensive training

The bimanual intensive training focuses activities that required the use of both hands.

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

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

Design outcomes

Primary

MeasureTime frameDescription
Changes from muscle strengthbaseline, week 8, week 24Measured by Electromyography (EMG)
Changes from String Beads Test (SBT)weekly test (from baseline to week 8)
Changes from Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2)baseline, week 4, week 8, week 24
Performance changes assessed by Kinematics Analysisbaseline, week 8, week 24Kinematic Analysis including parameters of endpoint control, inter-joints coordination, and trunk involvement, we will analyse children's performance changes from performing reaching tasks
Changes from Melbourne Assessment 2 (MA-2)baseline, week 4, week 8, week 24
Changes from Pediatric Motor Activity Log-Revised (PMAL-R)baseline, week 4, week 8, week 24
Changes from ABILHAND-Kidsbaseline, week 4, week 8, week 24
Changes from Test of Playfulness (ToP)week 1, week 4, week 5, week 8
Changes from Box and Block Test (BBT)weekly test (from baseline to week 8)
Changes from Engagement Questionnaire (EQ)weekly test (from week 1 to week 8)
Changes from Satisfactory Questionnaire (SQ)baseline, week 4, week 8, week 24
Changes from Building Tower Test (BTT)weekly test (from baseline to week 8)

Secondary

MeasureTime frame
Changes from Cerebral Palsy Quality of Life Questionnaire for Children (CPQOL)baseline, week 4, week 8, week 24
Changes from Parenting Stress Index-Short Form (PSI-short)baseline, week 4, week 8, week 24
Changes from Pediatric Evaluation of Disability Inventory (PEDI)baseline, week 4, week 8, week 24

Countries

Taiwan

Contacts

Primary ContactTien-Ni Wang
tnwang@ntu.edu.tw886-2-33668163

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026