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

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.

Study Overview

• Status: Unknown
• Conditions: Hemiplegic Cerebral Palsy With Spasticity (Diagnosis)
• Intervention / Treatment: Other: Constraint Induced Movement Therapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: YoungSub Hwang, researcher; Phone Number: +821027182034; Email: asiaargento@naver.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06351
    • Recruiting
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CIMT group; Two-hour mCIMT per day for 15 days (dosage = 30 hours) 24-hour restraint for 3 weeks	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 Names: CIMT
No Intervention: Control group; no CIMT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accelerometers(physical activity performance)	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.	3 days
Pediatric Motor Activity Log(PMAL)	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)	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pediatric Evaluation of Disability Inventory(PEDI)	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	30 minutes
Peabody Developmental Motor Scales-2(PDMS-2)	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).	30 minutes
Gross motor function measure - 66(GMFM-66)	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).	30 minutes

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Publications and helpful links

General Publications

• Hwang YS, Kwon JY. Effects of Modified Constraint-Induced Movement Therapy in Real-World Arm Use in Young Children with Unilateral Cerebral Palsy: A Single-Blind Randomized Trial. Neuropediatrics. 2020 Aug;51(4):259-266. doi: 10.1055/s-0040-1702220. Epub 2020 Mar 6.

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2018
• Primary Completion (Anticipated): April 8, 2019
• Study Completion (Anticipated): December 30, 2019

Study Registration Dates

• First Submitted: January 26, 2018
• First Submitted That Met QC Criteria: January 26, 2018
• First Posted (Actual): February 1, 2018

Study Record Updates

• Last Update Posted (Actual): February 27, 2019
• Last Update Submitted That Met QC Criteria: February 25, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: 2017-11-120

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No