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Trial record 58 of 163 for:    Recruiting, Not yet recruiting, Available Studies | "Cerebral Palsy"

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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ClinicalTrials.gov Identifier: NCT03418519
Recruitment Status : Recruiting
First Posted : February 1, 2018
Last Update Posted : February 1, 2018
Sponsor:
Information provided by (Responsible Party):
Jeong Yi Kwon, Samsung Medical Center

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.

Condition or disease Intervention/treatment Phase
Hemiplegic Cerebral Palsy With Spasticity (Diagnosis) Other: Constraint Induced Movement Therapy Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : January 9, 2018
Estimated Primary Completion Date : November 8, 2018
Estimated Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CIMT group
4 hours a day for 15days(dosage = 60hours)
Other: Constraint Induced Movement Therapy
Constraint-induced movement therapy (CIMT) is a high-dosage, efficacious, rehabilitation approach used for children with hemiplegic cerebral palsy
Other Name: CIMT

No Intervention: Control group
no CIMT



Primary Outcome Measures :
  1. Actigraph(physical activity performance) [ Time Frame: 6 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.

  2. 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)


Secondary Outcome Measures :
  1. Pediatric Evaluation of Disability Inventory(PEDI) [ Time Frame: 30 minutes ]
    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

  2. Peabody Developmental Motor Scales-2(PDMS-2) [ Time Frame: 30 minutes ]
    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).

  3. Gross motor function measure(GMFM) [ Time Frame: 30 minutes ]
    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).

  4. Clinical Global Impression of improvement and severity(CGI-I, CGI-S) [ Time Frame: 20 minutes ]
    The CGI acomprises two companion one-item measures evaluating the following: (a) severity of psychopathology from 1 to 7 and (b) change from the initiation of treatment on a similar seven-point scale.

  5. Quality of Upper Extremity Skills Test(QUEST) [ Time Frame: 30 minutes ]
    The QUEST is a criterion-referenced measurement tool, developed to evaluate upper extremity quality of movement in children with CP aged from 18 months to 8 years



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Ages Eligible for Study:   18 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • unable to walk
  • botox injection in upper extremity within 6months
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03418519


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

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 06351
Contact: JEONG-YI KWON, MD, PHD    +8210-4591-1039    jeongyi.kwon@samsung.com   
Principal Investigator: JEONG-YI KWON, MD         
Sponsors and Collaborators
Samsung Medical Center

Responsible Party: Jeong Yi Kwon, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03418519     History of Changes
Other Study ID Numbers: 2017-11-120
First Posted: February 1, 2018    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases