Therapeutic Effects of Constraint-Induced Movement Therapy on Young Children With Cerebral Palsy

July 10, 2020 updated by: Jeong Yi Kwon, Samsung Medical Center
This study evaluates the therapeutic effects of constraint-induced movement therapy on infants and children with hemiplegic cerebral palsy. Half of the participants will receive CIMT (constraint-induced movement therapy) and others will not.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study evaluates the therapeutic effects of constraint-induced movement therapy on infants and children with hemiplegic cerebral palsy. Half of the participants will receive CIMT (constraint-induced movement therapy) and others will not.

Participants will be randomly assigned to either CIMT group or control group. Children of the CIMT group will wear forearm splint 24 hours for 3 weeks to inhibit use of the unaffected arm.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 5 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • spastic hemiplegic cerebral palsy patients
  • 7~36 months old

Exclusion Criteria:

  • cognitive impairment severe enough to make participation impossible
  • uncontrolled epilepsy
  • visual or hearing impairment
  • musculoskeletal disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Constraint-induced movement therapy
Children in constraint-induced movement therapy (CIMT) group will wear forearm splint on the unaffected arm 24 hours for 3 weeks, and receive 15 mCIMT sessions(30-hour dosage)
Other: Constraint-induced movement therapy
The constraint-induced movement therapy (CIMT) program requires children to wear forearm splint on the unaffected arm 24 hours for 3 weeks. The program consists of 5 sessions per week for 3 weeks.
No Intervention: Control
Children in control group will receive only traditional rehab therapies without wearing splint

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline Pediatric Motor Activity Log (PMAL) Score at Post Test
Time Frame: baseline and 4 weeks
The PMAL was derived from the Motor Activity Log, which is used as an assessment tool in adults who participated CIMT, to measure changes in upper extremity use in real life. This parental assessment tool rates the use of the children's affected upper extremities in daily activities. Twenty-two arm-hand functional tasks that are typical for children aged 7 months to 8 years (e.g., taking off socks or shoes, holding a cup) were assessed and collected as a systemic data. The test has two components: (1) how often (PMAL HO) and (2) how well (PMAL HW). Parents rate PMAL HO on a 6-point scale from 0 (not at all) to 5 (all the time) and PMAL HW from 0 (does not use) to 5 (same as the unaffected arm). This tool has a high test-retest reliability (r=0.94; P<0.01) and a high internal consistency (Cronbach's α=0.88 to 0.95).
baseline and 4 weeks
Change From Baseline Accelerometers_Vector Magnitude Average Counts(VMA) at Post Test
Time Frame: baseline and 4 weeks
To evaluate the upper limb use in the real-world, participants wore two accelerometers (one on each wrist). Three variables were measured using accelerometers: vector magnitude average counts (VMA), percent of time in moderate to vigorous physical activity (% MVPA), and use ratio (UR). VMA refers to the magnitude of the resulting vector that forms when combining the sampled acceleration from all three axes.
baseline and 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline Pediatric Evaluation of Disability Inventory (PEDI) at Post Test
Time Frame: baseline and 4 weeks
The Pediatric Evaluation of Disability Inventory (PEDI) is a reliable and valid parent-report assessment that evaluates the performance, changes, and capabilities of functional activities in children with disabilities aged between 6 months and 7.5 years. Within the three domains of (1) self-care, (2) mobility, and (3) social function, it measures three scales: (1) functional skills; (2) caregiver assistance; and (3) modifications. In this study, only the functional skills scale was used because it directly evaluates the current capabilities of selected tasks. Therefore, the PEDI scores in this study reflect the functional skill of the children on a scale between 0 and 100: 0 indicates no ability, and 100 indicates full capability to perform the selected items.
baseline and 4 weeks
Change From Baseline Peabody Developmental Motor Scales-2 (PDMS-2) at Post Test
Time Frame: baseline and 4 weeks
The PDMS-2 is a standardized, norm-referenced test, which includes gross motor and fine motor domains. All items of the PDMS-2 are scored on a 3-point scale (0 to 2): 0 is assigned when the child cannot perform the item or when the attempts do not meet the criteria of the item; 1 is assigned when the attempts do not meet for successful performance, but the behavior is emerging; and 2 indicates that the behavior is emerging, and the criterion for successful performance is fully met. The standard score and developmental age equivalent are obtained by converting the raw score of each subtest according to the criteria of the PDMS-2 manual; the standard score was used for this study. The interrater reliability and internal consistency of the fine motor domain were reported as 0.98 and 0.96, respectively. The predictive validity was reported as 0.91.
baseline and 4 weeks
Change From Baseline Gross Motor Function Measure (GMFM) at Post Test
Time Frame: baseline and 4 weeks
GMFM-88 is a measure developed to evaluate the gross motor function changes in CP children. It has five components: lying and rolling, sitting, kneeling and crawling, standing, and walking. The score of each dimension is expressed as a percentage of the maximum score. The GMFM-66, which includes 66 items of the original 88 items. Item scoring is the same for the GMFM-88 and the GMFM-66. There is a scoring system with each item scored as 0, 1, 2, 3, or "not tested". A scoring key of 0 - does not initiate, 1 - initiates, 2 - partially completes, and 3 - completed, is used. Scoring the GMFM-66 requires the use of a computer program called the Gross Motor Ability Estimator (GMAE). Individual item scores are entered and a mathematical algorithm calculates an interval level total score. The total score is an estimate of the child's gross motor function. The range of total score is from 0 to 100. The higher values represent a better outcome.
baseline and 4 weeks
Change From Baseline Accelerometers_% Moderate to Vigorous Physical Activity(MVPA) at Post Test
Time Frame: baseline and 4 weeks
MVPA is a category of activity intensity, which is measured with metabolic equivalents (METs). Moderate-intensity physical activity is defined as 3-6 METs, and vigorous-intensity physical activity is defined as any activity above 6 METs. This means that MVPA is any activity over 3 METs.
baseline and 4 weeks
Change From Baseline Accelerometers_Use Ratio at Post Test
Time Frame: baseline and 4 weeks
Use Ratio was calculated by dividing the hours of use of the affected limb by the hours of use of the non-affected limb (affected use/unaffected use).
baseline and 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

  • Principal Investigator: Jeong-Yi Kwon, PhD, Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2015

Primary Completion (Actual)

September 28, 2019

Study Completion (Actual)

September 28, 2019

Study Registration Dates

First Submitted

February 25, 2019

First Submitted That Met QC Criteria

February 26, 2019

First Posted (Actual)

February 28, 2019

Study Record Updates

Last Update Posted (Actual)

July 28, 2020

Last Update Submitted That Met QC Criteria

July 10, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-06-100-008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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