A Comparative Analysis on Physical Activity Performance and Motor Function of Affected Upper Extremity Before and After a CIMT Program in Young Children With Hemiparetic Cerebral Palsy
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|ClinicalTrials.gov Identifier: NCT03418519|
Recruitment Status : Recruiting
First Posted : February 1, 2018
Last Update Posted : February 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hemiplegic Cerebral Palsy With Spasticity (Diagnosis)||Other: Constraint Induced Movement Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Comparative Analysis on Physical Activity Performance and Motor Function of Affected Upper Extremity Before and After a CIMT Program in Young Children With Hemiparetic Cerebral Palsy|
|Actual Study Start Date :||January 9, 2018|
|Estimated Primary Completion Date :||November 8, 2018|
|Estimated Study Completion Date :||December 30, 2018|
Experimental: CIMT group
4 hours a day for 15days(dosage = 60hours)
Other: Constraint Induced Movement Therapy
Constraint-induced movement therapy (CIMT) is a high-dosage, efficacious, rehabilitation approach used for children with hemiplegic cerebral palsy
Other Name: CIMT
No Intervention: Control group
- Actigraph(physical activity performance) [ Time Frame: 6 days ]For the upper limb use assessment, participants wear two accelerometers (one on each wrist). To quantify the affected upper limb movement relative to the unaffected upper limb before and after the CIMT program, two other variables are computed: use ratio and magnitude ratio. The use ratio is the ratio of the active duration for the affected arm to that for the unaffected arm. The magnitude ratio quantifies the contribution of the affected upper limb to activity.
- Pediatric Motor Activity Log(PMAL) [ Time Frame: 30 minutes ]The Pediatric Motor Activity Log (PMAL) is a parent-report measure of the use, by children with hemiplegic cerebral palsy, of their affected upper limb in everyday activities. Each item is scored 0-5(0= Never used affected arm , 5= Used affected arm on almost every occasion)
- Pediatric Evaluation of Disability Inventory(PEDI) [ Time Frame: 30 minutes ]The PEDI is a parental-report, or structured-interview, instrument used by pediatric physical therapists and other rehabilitation professionals to assess functional abilities of young children children
- Peabody Developmental Motor Scales-2(PDMS-2) [ Time Frame: 30 minutes ]The PDMS-2 consists of six subtests: Reflexes (for children from birth through 11 months), Stationary (ability to sustain control of body within its center of gravity), Locomotion (ability to move from one place to another), Object Manipulation (ability to manipulate balls for children 12 months and older), Grasping (ability to use hands), and Visual-Motor Integration (ability to use visual perpetual skills to perform complex eye-hand coordination tasks).
- Gross motor function measure(GMFM) [ Time Frame: 30 minutes ]The 88 items of the GMFM are measured by observation of the child and scored on a 4-point ordinal scale (0=does not initiate, 1=initiates <10% of activity, 2=partially completes 10% to <100% of activity, 3=completes activity). The items are weighted equally and grouped into 5 dimensions: (1) lying and rolling (17 items), (2) sitting (20 items), (3) crawling and kneeling (14 items), (4) standing (13 items), and (5) walking, running, jumping (24 items).
- Clinical Global Impression of improvement and severity(CGI-I, CGI-S) [ Time Frame: 20 minutes ]The CGI acomprises two companion one-item measures evaluating the following: (a) severity of psychopathology from 1 to 7 and (b) change from the initiation of treatment on a similar seven-point scale.
- Quality of Upper Extremity Skills Test(QUEST) [ Time Frame: 30 minutes ]The QUEST is a criterion-referenced measurement tool, developed to evaluate upper extremity quality of movement in children with CP aged from 18 months to 8 years
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): NCT03418519
|Contact: YoungSub Hwang, email@example.com|
|Korea, Republic of|
|Samsung Medical Center||Recruiting|
|Seoul, Korea, Republic of, 06351|
|Contact: JEONG-YI KWON, MD, PHD +8210-4591-1039 firstname.lastname@example.org|
|Principal Investigator: JEONG-YI KWON, MD|