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

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

Sponsors

Lead sponsor: Samsung Medical Center

Source 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.

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.

Overall Status Recruiting
Start Date September 14, 2015
Completion Date September 2019
Primary Completion Date June 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change from Baseline Pediatric Motor Activity Log (PMAL) score at post test baseline and 4 weeks
Change from Baseline Accelerometers_VMA at post test baseline and 4 weeks
Secondary Outcome
Measure Time Frame
Change from Baseline Pediatric Evaluation of Disability Inventory (PEDI) at post test baseline and 4 weeks
Change from Baseline Peabody Developmental Motor Scales-2 (PDMS-2) at post test baseline and 4 weeks
Change from Baseline Gross Motor Function Measure (GMFM) at post test baseline and 4 weeks
Change from Baseline Accelerometers_% MVPA at post test baseline and 4 weeks
Change from Baseline Accelerometers_UR at post test baseline and 4 weeks
Enrollment 30
Condition
Intervention

Intervention type: Other

Intervention name: Constraint-induced movement therapy

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.

Arm group label: Constraint-induced movement therapy

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

Gender: All

Minimum age: 7 Months

Maximum age: 36 Months

Healthy volunteers: No

Location
facility status contact investigator
Samsung Medical Center Recruiting JEONG-YI KWON, MD, PHD +8210-4591-1039 [email protected] JEONG-YI KWON, MD Principal Investigator
Location Countries

Korea, Republic of

Verification Date

February 2019

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Samsung Medical Center

Investigator full name: Jeong Yi Kwon

Investigator title: Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Constraint-induced movement therapy

Arm group type: Experimental

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 group label: Control

Arm group type: No Intervention

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

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Single (Outcomes Assessor)

Source: ClinicalTrials.gov