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

NCT03858335 | Completed Results

• 1 other identifier: 2015-06-100-008
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy Spastic Hemiplegic

Keywords

constraint-induced movement therapy; hemiplegia; hand function; gross motor

Outcome Measures

Primary Outcomes (2)

• Change From Baseline Pediatric Motor Activity Log (PMAL) Score at Post Test

  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).

  baseline and 4 weeks

• Change From Baseline Accelerometers_Vector Magnitude Average Counts(VMA) at Post Test

  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.

  baseline and 4 weeks

Secondary Outcomes (5)

• 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_% Moderate to Vigorous Physical Activity(MVPA) at Post Test

  baseline and 4 weeks

• Change From Baseline Accelerometers_Use Ratio at Post Test

  baseline and 4 weeks

Study Arms (2)

Constraint-induced movement therapy

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

Constraint-induced movement therapy OTHER

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.

Constraint-induced movement therapy

Eligibility Criteria

• Age: 7 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• spastic hemiplegic cerebral palsy patients
• \~36 months old

You may not qualify if:

• cognitive impairment severe enough to make participation impossible
• uncontrolled epilepsy
• visual or hearing impairment
• musculoskeletal disorders

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

Location

MeSH Terms

Conditions

Hemiplegia

Interventions

Constraint Induced Movement Therapy

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Physical Therapy Modalities; Therapeutics; Rehabilitation

Results Point of Contact

• Title: Jeong-Yi Kwon
• Organization: Samsung Medical Center

jeongyi.kwon@samsung.com

+821045911039

Study Officials

• Jeong-Yi Kwon, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 25, 2019
• First Posted: February 28, 2019
• Study Start: September 14, 2015
• Primary Completion: September 28, 2019
• Study Completion: September 28, 2019
• Last Updated: July 28, 2020
• Results First Posted: July 28, 2020

Record last verified: 2020-07

Locations

KR (1)