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Efficacy of Modified Constraint-induced Movement Therapy in Children With Brain Damage

Primary Purpose

Brain Damage, Cerebral Palsy, Traumatic Brain Damage

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Modified Constraint-induced Movement Therapy
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Damage focused on measuring brain damage, constraint induced movement therapy, kinematic, function, outcome, Quality of life

Eligibility Criteria

4 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Development learned-nonuse
  2. Age range 4y/o-15y/o
  3. Wrist ext 10˚, MP j't ext 10˚ in affected U/E
  4. Can fallow up the simple instruction
  5. Modified Ashworth Scale ≦2
  6. Pediatric Motor Activity Log ≦2.5 (average)

Exclusion Criteria:

  1. Related muscle skeleton surgery
  2. Selective dorsal rhizotomy
  3. Botulinum toxin in 6 months
  4. Visual perception impaired
  5. Hearing perception impaired
  6. Balance ability impaired (in constrained)

Sites / Locations

  • Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Constraint-induced Movement Therapy

Transditional rehabilitation

Arm Description

Outcomes

Primary Outcome Measures

Bruininks-Oseretsky Test of Motor Proficiency (BOTMP)
All children underwent a series of upper limb assessments, including kinematic analysis and functional measures (primary and secondary outcomes), before the start of the intervention (pretreatment). An occupational therapist blinded to group assignment was trained to administer these measures. All participants underwent these assessments at 4 weeks immediately after intervention (post-treatment), and at 12-week follow-up and 24-week follow-up.
Peabody Development Motor Scales, subtest fine motor (PDMS-Ⅱ)
Kinematic analysis

Secondary Outcome Measures

Pediatric Motor Activity Log ( PMAL )
All children underwent a series of upper limb assessments, including kinematic analysis and functional measures (primary and secondary outcomes), before the start of the intervention (pretreatment). An occupational therapist blinded to group assignment was trained to administer these measures. All participants underwent these assessments at 4 weeks immediately after intervention (post-treatment), and at 12-week follow-up and 24-week follow-up.
Pediatric Functional Independence Measure ( WeeFIM )
Cerebral palsy quality of life (CPQoL)

Full Information

First Posted
January 4, 2010
Last Updated
July 30, 2012
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01076257
Brief Title
Efficacy of Modified Constraint-induced Movement Therapy in Children With Brain Damage
Official Title
Efficacy of Modified Constraint-induced Movement Therapy in Children With Brain Damage: Evidence of Kinematic Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This research centers on the comparison of the immediate efficacy (right after therapy) and the maintained efficacy (3 months and 6 months) between "Modified Constraint-Induced Movement Therapy" (mCIMT) group and control group at different age.
Detailed Description
"Modified Constraint-Induced Movement Therapy" is one of the most recent treatments for children with Brain damage. This well-designed and follow-up RCT study compared home-based CIT with a control intervention (traditional rehabilitation, TR) by combining kinematic analysis and clinical evaluation, which is possible to examine whether functional improvement is accompanied by a change in motor control. We hypothesized that home-based CIT would induce better motor control strategies (shorter RT, MT, lesser MUs, MGA, and PMGA, and larger peak velocity (PV)) for greater functional gains than TR. Furthermore, the beneficial effects would be maintained at 3 and 6 months of follow-up. Findings of this study allow clinicians to understand the underlying motor control changes for functional improvement after home-based CIT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Damage, Cerebral Palsy, Traumatic Brain Damage
Keywords
brain damage, constraint induced movement therapy, kinematic, function, outcome, Quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Constraint-induced Movement Therapy
Arm Type
Experimental
Arm Title
Transditional rehabilitation
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Modified Constraint-induced Movement Therapy
Other Intervention Name(s)
Constraint-Induced Therapy, Forced-use Therapy, Immobilization Therapy
Intervention Description
Home based CIT Restriction of the less affected limb Intensive practice using affected limb Positive experience Functional task (task)
Primary Outcome Measure Information:
Title
Bruininks-Oseretsky Test of Motor Proficiency (BOTMP)
Description
All children underwent a series of upper limb assessments, including kinematic analysis and functional measures (primary and secondary outcomes), before the start of the intervention (pretreatment). An occupational therapist blinded to group assignment was trained to administer these measures. All participants underwent these assessments at 4 weeks immediately after intervention (post-treatment), and at 12-week follow-up and 24-week follow-up.
Time Frame
4 weeks (post-treatment), 12 week, 24 week
Title
Peabody Development Motor Scales, subtest fine motor (PDMS-Ⅱ)
Time Frame
4 weeks (post-treatment), 12 week, 24 week
Title
Kinematic analysis
Time Frame
4 weeks (post-treatment), 12 week, 24 week
Secondary Outcome Measure Information:
Title
Pediatric Motor Activity Log ( PMAL )
Description
All children underwent a series of upper limb assessments, including kinematic analysis and functional measures (primary and secondary outcomes), before the start of the intervention (pretreatment). An occupational therapist blinded to group assignment was trained to administer these measures. All participants underwent these assessments at 4 weeks immediately after intervention (post-treatment), and at 12-week follow-up and 24-week follow-up.
Time Frame
4 weeks (post-treatment), 12 week, 24 week
Title
Pediatric Functional Independence Measure ( WeeFIM )
Time Frame
4 weeks (post-treatment), 12 week, 24 week
Title
Cerebral palsy quality of life (CPQoL)
Time Frame
4 weeks (post-treatment), 12 week, 24 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Development learned-nonuse Age range 4y/o-15y/o Wrist ext 10˚, MP j't ext 10˚ in affected U/E Can fallow up the simple instruction Modified Ashworth Scale ≦2 Pediatric Motor Activity Log ≦2.5 (average) Exclusion Criteria: Related muscle skeleton surgery Selective dorsal rhizotomy Botulinum toxin in 6 months Visual perception impaired Hearing perception impaired Balance ability impaired (in constrained)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chia-Ling chen, MD,PhD
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan

12. IPD Sharing Statement

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Efficacy of Modified Constraint-induced Movement Therapy in Children With Brain Damage

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