Hemiplegic Cerebral Palsy With Spasticity (Diagnosis)NCT03418519
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
A study testing Constraint Induced Movement Therapy in people with Hemiplegic Cerebral Palsy With Spasticity (Diagnosis), run by Samsung Medical Center at 1 site in South Korea.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 36 months
- Conditions the study is for
- Hemiplegic Cerebral Palsy With Spasticity (Diagnosis)
- What is being tested?
- Constraint Induced Movement Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Jan 2018to 30 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- diagnosed with spastic hemiplegic cerebral palsy
- age between 18 months and 36 months
- Mini-MACS level 1-4
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 06351
JEONG-YI KWON, MD, PHD, +8210-4591-1039, jeongyi.kwon@samsung.com
JEONG-YI KWON, MD
About this study
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.
- Being tested
- Constraint Induced Movement Therapy
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Constraint Induced Movement TherapyOther
Also called CIMT
Constraint-induced movement therapy (CIMT) is a high-dosage, efficacious, rehabilitation approach used for children with hemiplegic cerebral palsy
| Study group | Role | What they receive |
|---|---|---|
| CIMT group | Experimental | Two-hour mCIMT per day for 15 days (dosage = 30 hours)
24-hour restraint for 3 weeks Receives: Other: Constraint Induced Movement Therapy |
| Control group | No intervention | no CIMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 30 minutes
Secondary outcomes (3)
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
Measured: 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).
Measured: 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).
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2018
- Study start9 Jan 2018
- Primary completion8 Apr 2019 (estimated)
- Study completion30 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemiplegic Cerebral Palsy With Spasticity (Diagnosis)Studies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeong Yi Kwon, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03418519
- Sponsor's protocol ID
- 2017-11-120
- Status last verified
- Feb 2019
- First submitted
- 26 Jan 2018
- Last updated
- 27 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03418519
- Acronym / sponsor ID
- 2017-11-120
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 9 Jan 2018 (actual)
- Primary completion
- 8 Apr 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 1 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CIMT group | Experimental | Other: Constraint Induced Movement TherapyTwo-hour mCIMT per day for 15 days (dosage = 30 hours) 24-hour restraint for 3 weeks |
| Control group | No intervention | –no CIMT |
Who may qualify
- Ages
- 18 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- diagnosed with spastic hemiplegic cerebral palsy
- age between 18 months and 36 months
- Mini-MACS level 1-4
Key exclusion criteria (7 listed)
- botox injection in upper extremity within 6 months
- poor cooperation with cognitive impairment
- any musculoskeletal disease
- visual or hearing impairment
- uncontrollable epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Constraint Induced Movement TherapyAlso: CIMTConstraint-induced movement therapy (CIMT) is a high-dosage, efficacious, rehabilitation approach used for children with hemiplegic cerebral palsy | Other | CIMT group |
Primary outcome
Accelerometers(physical activity performance)
Time frame: 3 days
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.
Pediatric Motor Activity Log(PMAL)
Time frame: 30 minutes
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)
3 secondary outcomes
Pediatric Evaluation of Disability Inventory(PEDI)
Time frame: 30 minutes
Peabody Developmental Motor Scales-2(PDMS-2)
Time frame: 30 minutes
Gross motor function measure - 66(GMFM-66)
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
- Derived from this study: PubMed 32143221Hwang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Constraint Induced Movement Therapy in people with Hemiplegic Cerebral Palsy With Spasticity (Diagnosis), run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact YoungSub Hwang, researcher (+821027182034, asiaargento@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accelerometers(physical activity performance) (time frame: 3 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03418519, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2019.