NCT03418519

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 9, 2018

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 1, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

February 27, 2019

Status Verified

February 1, 2019

Enrollment Period

1.2 years

First QC Date

January 26, 2018

Last Update Submit

February 25, 2019

Conditions

Hemiplegic Cerebral Palsy With Spasticity (Diagnosis)

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Pediatric Evaluation of Disability Inventory(PEDI)

    30 minutes

  • Peabody Developmental Motor Scales-2(PDMS-2)

    30 minutes

  • Gross motor function measure - 66(GMFM-66)

    30 minutes

Study Arms (2)

CIMT group

EXPERIMENTAL

Two-hour mCIMT per day for 15 days (dosage = 30 hours) 24-hour restraint for 3 weeks

Other: Constraint Induced Movement Therapy

Control group

NO INTERVENTION

no CIMT

Interventions

Constraint Induced Movement TherapyOTHER

Constraint-induced movement therapy (CIMT) is a high-dosage, efficacious, rehabilitation approach used for children with hemiplegic cerebral palsy

Also known as: CIMT
CIMT group

Eligibility Criteria

Age18 Months - 36 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

Related Publications (1)

  • 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.

    PMID: 32143221DERIVED

MeSH Terms

Conditions

Disease

Interventions

Constraint Induced Movement Therapy

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyPhysical Therapy ModalitiesTherapeuticsRehabilitation

Central Study Contacts

YoungSub Hwang, researcher

CONTACT

+821027182034asiaargento@naver.com

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

January 26, 2018

First Posted

February 1, 2018

Study Start

January 9, 2018

Primary Completion

April 8, 2019

Study Completion

December 30, 2019

Last Updated

February 27, 2019

Record last verified: 2019-02

Locations

KR(1)