Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03858335
Recruitment Status : Completed
First Posted : February 28, 2019
Results First Posted : July 28, 2020
Last Update Posted : July 28, 2020
Sponsor:
Information provided by (Responsible Party):
Jeong Yi Kwon, Samsung Medical Center

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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Spastic Hemiplegic Other: Constraint-induced movement therapy Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Therapeutic Effects of Constraint-Induced Movement Therapy on Young Children With Cerebral Palsy
Actual Study Start Date : September 14, 2015
Actual Primary Completion Date : September 28, 2019
Actual Study Completion Date : September 28, 2019

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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).

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   7 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03858335


Locations
Layout table for location information
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 06351
Sponsors and Collaborators
Samsung Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Jeong-Yi Kwon, PhD Samsung Medical Center
  Study Documents (Full-Text)

Documents provided by Jeong Yi Kwon, Samsung Medical Center:
Layout table for additonal information
Responsible Party: Jeong Yi Kwon, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03858335    
Other Study ID Numbers: 2015-06-100-008
First Posted: February 28, 2019    Key Record Dates
Results First Posted: July 28, 2020
Last Update Posted: July 28, 2020
Last Verified: July 2020
Keywords provided by Jeong Yi Kwon, Samsung Medical Center:
constraint-induced movement therapy
hemiplegia
hand function
gross motor
Additional relevant MeSH terms:
Layout table for MeSH terms
Cerebral Palsy
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases