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

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
mCIMT + SR
Control
Sponsored by
University of Western Sydney
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

  • The Hong Kong Polytechnic University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

mCIMT + SR

Control

Arm Description

modified constraint-induced movement therapy plus self regulation

conventional occupational therapy

Outcomes

Primary Outcome Measures

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)
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)

Secondary Outcome Measures

Change in Caregiver Functional Use Survey
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 Grip strength
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 Pinch strength
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
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)

Full Information

First Posted
September 22, 2016
Last Updated
November 3, 2016
Sponsor
University of Western Sydney
Collaborators
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT02957708
Brief Title
Constraint-induced Movement Therapy and Self-regulation for Children With Cerebral Palsy
Official Title
Effectiveness of Modified Constraint-induced Movement Therapy and Self-regulation Learning for Children With Hemiplegic Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Western Sydney
Collaborators
The Hong Kong Polytechnic University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mCIMT + SR
Arm Type
Experimental
Arm Description
modified constraint-induced movement therapy plus self regulation
Arm Title
Control
Arm Type
Active Comparator
Arm Description
conventional occupational therapy
Intervention Type
Other
Intervention Name(s)
mCIMT + SR
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control
Other Intervention Name(s)
Conventional occupational therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Bruininks-Oseretsky Test of Motor Proficiency
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)
Time Frame
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)
Title
Change in Jebsen-Taylor Test of Hand Funcion
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)
Time Frame
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 Outcome Measure Information:
Title
Change in Caregiver Functional Use Survey
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)
Time Frame
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)
Title
Change in Grip strength
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)
Time Frame
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)
Title
Change in Pinch strength
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)
Time Frame
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)
Title
Change in Modified Ashworth scale
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)
Time Frame
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 Pre-specified Outcome Measures:
Title
Change in Choice reaction task
Description
The children respond by pressing the buttons on an oversized number pad with keys specifying for pressing with the index finger or the thumb. Stimuli are pictures of an outlined hand with responding digit highlighted. When the child sees a thumb highlighted, he or she is required to press the thumb key with the thumb. Alternatively, he or she will press the index finger key with the index finger if the index finger is highlighted in the picture. Event-related potentials (ERPs) are recorded from a 64-channel array of electrodes placed in an extended 10-20 system.
Time Frame
Two days before and two days after the three-week mCIMT + SR intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
The Hong Kong Polytechnic University
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

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

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