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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01076257
First received: January 4, 2010
Last updated: July 30, 2012
Last verified: May 2010
  Purpose

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.


Condition Intervention
Brain Damage
Cerebral Palsy
Traumatic Brain Damage
Behavioral: Modified Constraint-induced Movement Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Modified Constraint-induced Movement Therapy in Children With Brain Damage: Evidence of Kinematic Study

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • Bruininks-Oseretsky Test of Motor Proficiency (BOTMP) [ Time Frame: 4 weeks (post-treatment), 12 week, 24 week ] [ Designated as safety issue: No ]
    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) [ Time Frame: 4 weeks (post-treatment), 12 week, 24 week ] [ Designated as safety issue: No ]
  • Kinematic analysis [ Time Frame: 4 weeks (post-treatment), 12 week, 24 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pediatric Motor Activity Log ( PMAL ) [ Time Frame: 4 weeks (post-treatment), 12 week, 24 week ] [ Designated as safety issue: No ]
    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 ) [ Time Frame: 4 weeks (post-treatment), 12 week, 24 week ] [ Designated as safety issue: No ]
  • Cerebral palsy quality of life (CPQoL) [ Time Frame: 4 weeks (post-treatment), 12 week, 24 week ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: June 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Constraint-induced Movement Therapy Behavioral: Modified Constraint-induced Movement Therapy

Home based CIT

  1. Restriction of the less affected limb
  2. Intensive practice using affected limb
  3. Positive experience
  4. Functional task (task)
Other Names:
  • Constraint-Induced Therapy
  • Forced-use Therapy
  • Immobilization Therapy
Transditional rehabilitation Behavioral: Modified Constraint-induced Movement Therapy

Home based CIT

  1. Restriction of the less affected limb
  2. Intensive practice using affected limb
  3. Positive experience
  4. Functional task (task)
Other Names:
  • Constraint-Induced Therapy
  • Forced-use Therapy
  • Immobilization Therapy

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.

  Eligibility

Ages Eligible for Study:   4 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01076257

Locations
Taiwan
Chang Gung Memorial Hospital
Taoyuan, Taiwan, 333
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Chia-Ling chen, MD,PhD Chang Gung Memorial Hospital
  More Information

No publications provided

Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01076257     History of Changes
Other Study ID Numbers: 97-1823B
Study First Received: January 4, 2010
Last Updated: July 30, 2012
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Chang Gung Memorial Hospital:
brain damage
constraint induced movement therapy
kinematic
function
outcome
Quality of life

Additional relevant MeSH terms:
Cerebral Palsy
Brain Injuries
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on August 28, 2014