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Status unknownNCT03418519Updated Feb 27, 2019

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

An interventional study of Constraint Induced Movement Therapy in Hemiplegic Cerebral Palsy With Spasticity (Diagnosis), sponsored by Samsung Medical Center. Status unknown at 1 site in Korea, Republic of. Open to participants aged 18 Months to 36 Months. Per ClinicalTrials.gov, last updated 2019-02-27.

Primary conditionnone(registry's first term: Disease)No conditionIs this wrong?Disease describes something many studies share rather than a condition a study is about. The study names no condition we can place it under, so it is not compared with other studies by condition.

Sponsored by Samsung Medical Center · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Months to 36 Months
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Hemiplegic Cerebral Palsy With Spasticity (Diagnosis)

Browse trials for

03

In context

Lead sponsor

Samsung Medical Center is the lead sponsor of 1,011 studies on the registry; 152 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Months to 36 Months
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
20 participants (estimated)

Study arms

  • 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

  • No intervention
    Control group

    no CIMT

Interventions

  • OtherConstraint Induced Movement Therapy

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

    Also known as: CIMT

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 days

  2. 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)

    Time frame: 30 minutes

Secondary outcomes

  1. 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

    Time frame: 30 minutes

  2. 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).

    Time frame: 30 minutes

  3. 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).

    Time frame: 30 minutes

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Study locations

1 of 1 sites recruiting
  • Samsung Medical Center
    Seoul, 06351, Korea, Republic of
    Recruiting
    • JEONG-YI KWON, MD, PHD · Contactjeongyi.kwon@samsung.com · +8210-4591-1039
    • JEONG-YI KWON, MD · Principal investigator
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References and documents

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. PubMed 32143221 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2018 (actual). Primary completion is estimated for Apr 2019, 14 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 26, 2018
First posted
Feb 1, 2018
StartActual
Jan 9, 2018
Primary completionEst.
Apr 8, 2019
CompletionEst.
Dec 30, 2019
Last update
Feb 27, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 27, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03418519
Responsible party
Jeong Yi Kwon (Professor, Samsung Medical Center) — Principal investigator
First posted
Feb 1, 2018
Start date
Jan 9, 2018
Primary completion
Apr 8, 2019 (estimated)
Completion
Dec 30, 2019 (estimated)
Last update
Feb 27, 2019

Study contacts

YoungSub Hwang, researcher
Contact
asiaargento@naver.com
+821027182034

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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