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

Not Applicable

Completed

• Conditions: Brain Damage; Cerebral Palsy; Traumatic Brain Damage
• Interventions: Behavioral: Modified Constraint-induced Movement Therapy

• Registration Number: NCT01076257
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2010-01-04
• Study First Submitted QC: 2010-02-24
• Study First Posted: 2010-02-26
• Status Verified: 2010-05
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Last Update Submitted: 2012-07-30
• Last Update Posted: 2012-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Constraint-induced Movement Therapy	Modified Constraint-induced Movement Therapy	-
Transditional rehabilitation	Modified Constraint-induced Movement Therapy	-

Primary Outcome Measures

Name	Time	Method
Bruininks-Oseretsky Test of Motor Proficiency (BOTMP)	4 weeks (post-treatment), 12 week, 24 week	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)	4 weeks (post-treatment), 12 week, 24 week
Kinematic analysis	4 weeks (post-treatment), 12 week, 24 week

Secondary Outcome Measures

Name	Time	Method
Pediatric Motor Activity Log ( PMAL )	4 weeks (post-treatment), 12 week, 24 week	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 )	4 weeks (post-treatment), 12 week, 24 week
Cerebral palsy quality of life (CPQoL)	4 weeks (post-treatment), 12 week, 24 week

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan