Constraint-induced Movement Therapy and Self-regulation for Children With Cerebral Palsy
- Conditions
- Cerebral Palsy
- Registration Number
- NCT02957708
- Lead Sponsor
- University of Western Sydney
- Brief Summary
This study examines the effect of combining modified constraint-induced movement therapy (mCIMT) and self-regulation (SR) in promoting upper limb function of children with hemiplegic cerebral palsy (CP) studying in a school-based setting.
- Detailed Description
Children diagnosed with hemiplegic CP are involved. A within-subject design is used with children acting as their own controls. The study is scheduled at three-week intervals. All children undergo conventional occupational therapy (OT) and modified constraint-induced movement therapy plus self-regulation (mCIMT + SR) program in a random order.
Both programs last for three weeks. Each program is followed by a three-week no-treatment period to measure the carry-over effect. The OT program consists of training on unimanual and bimanual tasks for 1 to 2 hours a week with daily home exercise. The mCIMT + SR program involves restraint of the unaffected upper limb of children using a cotton sling for 6 hours per day for 15 days. A one-hour structured task practice with the use of SR is provided during each 6-hour restraint.
The Bruininks-Oseretsky Test of Motor Proficiency, the Jebsen-Taylor Test of Hand Function, the Caregiver Functional Use Survey, a hand dynamometer, pinch gauge, and modified Ashworth scale are used for evaluation. All children are assessed for five times at 3-week interval: once before and twice after the conventional OT; and twice after the mCIMT + SR at 1 week and at 3 weeks.
Before and after the three-week intervention, the children participate in event-related potentials (ERP) sessions with a choice reaction task. Event-related potentials (ERP) technique is used to capture the changes in neural mechanism after intervention.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
- children with diagnosis of hemiplegic CP,
- 6-18 years of age studying at local special school for students with physical handicap (PH),
- intelligence ranging from normal to mild grade mental retardation,
- the ability to extend the wrist at least 20° and the metacarpophalangeal joint 10° from full flexion, and
- no balance problems sufficient to compromise safety.
- any health problems that were not associated with CP, and
- severe muscle tone with modified Ashworth scale scored greater than 3.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in Bruininks-Oseretsky Test of Motor Proficiency Assessment 1 (before intervention 1); Assessment 2 (after intervention 1); Assessment 3 (3 weeks after no treatment period and before intervention 2); Assessment 4 (after intervention 2); Assessment 5 (3 weeks after no treatment) (refer to description) Subtest 5 ((upper-limb coordination) and subtext 8 (speed and dexterity), testing the upper limb function are used.
Time frame:
Assessment 1 (within two days before intervention 1); Assessment 2 (within two days after the three-week intervention 1); Assessment 3 (3 weeks after no treatment period and before intervention 2); Assessment 4 (two days after the three-week intervention 2); Assessment 5 (3 weeks after no treatment)Change in Jebsen-Taylor Test of Hand Funcion Assessment 1 (before intervention 1); Assessment 2 (after intervention 1); Assessment 3 (3 weeks after no treatment period and before intervention 2); Assessment 4 (after intervention 2); Assessment 5 (3 weeks after no treatment) (refer to description) It assesses hand function using seven unimanual tasks: writing, turning cards over, picking up small commonly encountered objects, simulated eating, stacking checker, and moving light and heavy cans.
Time frame:
Assessment 1 (within two days before intervention 1); Assessment 2 (within two days after the three-week intervention 1); Assessment 3 (3 weeks after no treatment period and before intervention 2); Assessment 4 (two days after the three-week intervention 2); Assessment 5 (3 weeks after no treatment)
- Secondary Outcome Measures
Name Time Method Change in Grip strength Assessment 1 (before intervention 1); Assessment 2 (after intervention 1); Assessment 3 (3 weeks after no treatment period and before intervention 2); Assessment 4 (after intervention 2); Assessment 5 (3 weeks after no treatment) (refer to description) It is measured using a Jamar hand dynamometer.
Time frame:
Assessment 1 (within two days before intervention 1); Assessment 2 (within two days after the three-week intervention 1); Assessment 3 (3 weeks after no treatment period and before intervention 2); Assessment 4 (two days after the three-week intervention 2); Assessment 5 (3 weeks after no treatment)Change in Caregiver Functional Use Survey Assessment 1 (before intervention 1); Assessment 2 (after intervention 1); Assessment 3 (3 weeks after no treatment period and before intervention 2); Assessment 4 (after intervention 2); Assessment 5 (3 weeks after no treatment) (refer to description) It reviews caregivers' perceptions of how much and how well their child use the affected upper limb in the real-life situation.
Time frame:
Assessment 1 (within two days before intervention 1); Assessment 2 (within two days after the three-week intervention 1); Assessment 3 (3 weeks after no treatment period and before intervention 2); Assessment 4 (two days after the three-week intervention 2); Assessment 5 (3 weeks after no treatment)Change in Pinch strength Assessment 1 (before intervention 1); Assessment 2 (after intervention 1); Assessment 3 (3 weeks after no treatment period and before intervention 2); Assessment 4 (after intervention 2); Assessment 5 (3 weeks after no treatment) (refer to description) It is measured using a pinch gauge.
Time frame:
Assessment 1 (within two days before intervention 1); Assessment 2 (within two days after the three-week intervention 1); Assessment 3 (3 weeks after no treatment period and before intervention 2); Assessment 4 (two days after the three-week intervention 2); Assessment 5 (3 weeks after no treatment)Change in Modified Ashworth scale Assessment 1 (before intervention 1); Assessment 2 (after intervention 1); Assessment 3 (3 weeks after no treatment period and before intervention 2); Assessment 4 (after intervention 2); Assessment 5 (3 weeks after no treatment) (refer to description) It assesses muscle tone at the shoulder, elbow and wrist.
Time frame:
Assessment 1 (within two days before intervention 1); Assessment 2 (within two days after the three-week intervention 1); Assessment 3 (3 weeks after no treatment period and before intervention 2); Assessment 4 (two days after the three-week intervention 2); Assessment 5 (3 weeks after no treatment)
Trial Locations
- Locations (1)
The Hong Kong Polytechnic University
🇭🇰Hong Kong, Hong Kong
The Hong Kong Polytechnic University🇭🇰Hong Kong, Hong Kong