Back to resultsA 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
Primary Purpose
Hemiplegic Cerebral Palsy With Spasticity (Diagnosis)
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Constraint Induced Movement Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Hemiplegic Cerebral Palsy With Spasticity (Diagnosis)
Eligibility Criteria
Inclusion Criteria:
- diagnosed with spastic hemiplegic cerebral palsy
- age between 18 months and 36 months
- Mini-MACS level 1-4
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
Sites / Locations
- Samsung Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
CIMT group
Control group
Arm Description
Two-hour mCIMT per day for 15 days (dosage = 30 hours) 24-hour restraint for 3 weeks
no CIMT
Outcomes
Primary Outcome Measures
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.
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)
Secondary Outcome Measures
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
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).
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).
Full Information
NCT ID
NCT03418519
First Posted
January 26, 2018
Last Updated
February 25, 2019
Sponsor
Samsung Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03418519
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 9, 2018 (Actual)
Primary Completion Date
April 8, 2019 (Anticipated)
Study Completion Date
December 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegic Cerebral Palsy With Spasticity (Diagnosis)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CIMT group
Arm Type
Experimental
Arm Description
Two-hour mCIMT per day for 15 days (dosage = 30 hours)
24-hour restraint for 3 weeks
Arm Title
Control group
Arm Type
No Intervention
Arm Description
no CIMT
Intervention Type
Other
Intervention Name(s)
Constraint Induced Movement Therapy
Other Intervention Name(s)
CIMT
Intervention Description
Constraint-induced movement therapy (CIMT) is a high-dosage, efficacious, rehabilitation approach used for children with hemiplegic cerebral palsy
Primary Outcome Measure Information:
Title
Accelerometers(physical activity performance)
Description
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
Title
Pediatric Motor Activity Log(PMAL)
Description
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 Outcome Measure Information:
Title
Pediatric Evaluation of Disability Inventory(PEDI)
Description
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
Title
Peabody Developmental Motor Scales-2(PDMS-2)
Description
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
Title
Gross motor function measure - 66(GMFM-66)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosed with spastic hemiplegic cerebral palsy
age between 18 months and 36 months
Mini-MACS level 1-4
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
YoungSub Hwang, researcher
Phone
+821027182034
Email
asiaargento@naver.com
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JEONG-YI KWON, MD, PHD
Phone
+8210-4591-1039
Email
jeongyi.kwon@samsung.com
First Name & Middle Initial & Last Name & Degree
JEONG-YI KWON, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
32143221
Citation
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.
Results Reference
derived
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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
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