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

NCT02957708 | Completed DMC

• 1 other identifier: SR-CIMT_CP
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (2)

• Change in Bruininks-Oseretsky Test of Motor Proficiency

  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)

  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)

• Change in Jebsen-Taylor Test of Hand Funcion

  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)

  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)

Secondary Outcomes (4)

• 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)

• 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)

• 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)

• 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)

Other Outcomes (1)

• Change in Choice reaction task

  Two days before and two days after the three-week mCIMT + SR intervention

Study Arms (2)

mCIMT + SR

EXPERIMENTAL

modified constraint-induced movement therapy plus self regulation

Other: mCIMT + SR

Control

ACTIVE COMPARATOR

conventional occupational therapy

Other: Control

Interventions

mCIMT + SR OTHER

Each participant wears a customized cotton sling on the unaffected arm for six hours everyday. Participant is engaged in fifteen unimanual tasks during the three-week training that provides them sufficient challenge and opportunities for repetition. SR is incorporated on the 1-hour structured practice by using video playback to help participants realize their own performance for better learning. Participant first performs a task with videotaping, then identifies steps with problems or difficulties by video playback of participant's performance. Secondly, participant is asked for possible solutions, prompting is given if needed. Lastly, participant performs the activity by adopting the suggested solutions with videotaping again to facilitate participant's evaluation of new performance.

mCIMT + SR

Control OTHER

A combination of training on functional and remedial activities on unimanual tasks and bimanual tasks that based primarily on neurodevelopmental approach are provided. The training aims at increasing control, strength and functional use of their affected arm and hand, and improving bimanual coordination in performing daily activities. Each participant receives 1 to 2 hours of training per week at school. Home exercise including both unimanual and bimanual tasks is prescribed to them as well.

Also known as: Conventional occupational therapy

Control

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• children with diagnosis of hemiplegic CP,
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Western Sydney: lead
• The Hong Kong Polytechnic University: collaborator

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 22, 2016
• First Posted: November 8, 2016
• Study Start: December 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: November 8, 2016

Record last verified: 2016-11

Locations

HK (1)