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Constraint-induced Movement Therapy and Self-regulation for Children With Cerebral Palsy

U

University of Western Sydney

Status

Completed

Conditions

Cerebral Palsy

Treatments

Other: Control
Other: mCIMT + SR

Study type

Interventional

Funder types

Other

Identifiers

NCT02957708
SR-CIMT_CP

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

All

Ages

6 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

  • any health problems that were not associated with CP, and
  • severe muscle tone with modified Ashworth scale scored greater than 3.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

10 participants in 2 patient groups

mCIMT + SR
Experimental group
Description:
modified constraint-induced movement therapy plus self regulation
Treatment:
Other: mCIMT + SR
Control
Active Comparator group
Description:
conventional occupational therapy
Treatment:
Other: Control

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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