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

Not Applicable

• Conditions: Hemiplegic Cerebral Palsy With Spasticity (Diagnosis)
• Interventions: Other: Constraint Induced Movement Therapy

• Registration Number: NCT03418519
• Lead Sponsor: Samsung Medical Center

Brief Summary

This study evaluates CIMT(Constraint Induced Movement Therapy) in the treatment of physical activity performance and motor function of the weaker extremity in young children with cerebral palsy. Half of participants will receive CIMT while the other half will receive no treatment.

Detailed Description

Constraint-induced movement therapy (CIMT) is a short-term, intensive treatment to promote functional arm and hand skills in people with hemiparesis. It usually involves constraint of the non-involved extremity and intensive movement practice of the weaker extremity.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-01-09
• Study First Submitted: 2018-01-26
• Study First Submitted QC: 2018-01-26
• Study First Posted: 2018-02-01
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-25
• Last Update Posted: 2019-02-27
• Primary Completion: 2019-04-08
• Study Completion: 2019-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• diagnosed with spastic hemiplegic cerebral palsy
• age between 18 months and 36 months
• Mini-MACS level 1-4

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Exclusion Criteria

• botox injection in upper extremity within 6 months
• poor cooperation with cognitive impairment
• any musculoskeletal disease
• visual or hearing impairment
• uncontrollable epilepsy
• skin damage that makes impossible for participant to wear a splint
• Mini-MACS level 5

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CIMT group	Constraint Induced Movement Therapy	Two-hour mCIMT per day for 15 days (dosage = 30 hours) 24-hour restraint for 3 weeks

Primary Outcome Measures

Name	Time	Method
Accelerometers(physical activity performance)	3 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)	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)

Secondary Outcome Measures

Name	Time	Method
Pediatric Evaluation of Disability Inventory(PEDI)	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)	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 - 66(GMFM-66)	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).

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of