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

Primary Purpose

Cerebral Palsy Spastic Hemiplegic

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Constraint-induced movement therapy
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy Spastic Hemiplegic focused on measuring constraint-induced movement therapy, hemiplegia, hand function, gross motor

Eligibility Criteria

7 Months - 36 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Constraint-induced movement therapy

Control

Arm Description

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)

Children in control group will receive only traditional rehab therapies without wearing splint

Outcomes

Primary Outcome Measures

Change From Baseline Pediatric Motor Activity Log (PMAL) Score at Post Test
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 Ξ±=0.88 to 0.95).
Change From Baseline Accelerometers_Vector Magnitude Average Counts(VMA) at Post Test
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.

Secondary Outcome Measures

Change From Baseline Pediatric Evaluation of Disability Inventory (PEDI) at Post Test
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.
Change From Baseline Peabody Developmental Motor Scales-2 (PDMS-2) at Post Test
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.
Change From Baseline Gross Motor Function Measure (GMFM) at Post Test
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.
Change From Baseline Accelerometers_% Moderate to Vigorous Physical Activity(MVPA) at Post Test
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.
Change From Baseline Accelerometers_Use Ratio at Post Test
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).

Full Information

First Posted
February 25, 2019
Last Updated
July 10, 2020
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03858335
Brief Title
Therapeutic Effects of Constraint-Induced Movement Therapy on Young Children With Cerebral Palsy
Official Title
Therapeutic Effects of Constraint-Induced Movement Therapy on Young Children With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
September 14, 2015 (Actual)
Primary Completion Date
September 28, 2019 (Actual)
Study Completion Date
September 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy Spastic Hemiplegic
Keywords
constraint-induced movement therapy, hemiplegia, hand function, gross motor

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Constraint-induced movement therapy
Arm Type
Experimental
Arm Description
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)
Arm Title
Control
Arm Type
No Intervention
Arm Description
Children in control group will receive only traditional rehab therapies without wearing splint
Intervention Type
Other
Intervention Name(s)
Constraint-induced movement therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline Pediatric Motor Activity Log (PMAL) Score at Post Test
Description
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 Ξ±=0.88 to 0.95).
Time Frame
baseline and 4 weeks
Title
Change From Baseline Accelerometers_Vector Magnitude Average Counts(VMA) at Post Test
Description
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.
Time Frame
baseline and 4 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline Pediatric Evaluation of Disability Inventory (PEDI) at Post Test
Description
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.
Time Frame
baseline and 4 weeks
Title
Change From Baseline Peabody Developmental Motor Scales-2 (PDMS-2) at Post Test
Description
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.
Time Frame
baseline and 4 weeks
Title
Change From Baseline Gross Motor Function Measure (GMFM) at Post Test
Description
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.
Time Frame
baseline and 4 weeks
Title
Change From Baseline Accelerometers_% Moderate to Vigorous Physical Activity(MVPA) at Post Test
Description
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.
Time Frame
baseline and 4 weeks
Title
Change From Baseline Accelerometers_Use Ratio at Post Test
Description
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).
Time Frame
baseline and 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeong-Yi Kwon, PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of

12. IPD Sharing Statement

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

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