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

Sponsor

Chang Gung Memorial Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01076257

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Brain Damage Cerebral Palsy Traumatic Brain Damage	Behavioral: Modified Constraint-induced Movement Therapy	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Efficacy of Modified Constraint-induced Movement Therapy in Children With Brain Damage: Evidence of Kinematic Study

Study Start Date :

Jun 1, 2009

Actual Primary Completion Date :

Jul 1, 2010

Actual Study Completion Date :

Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Constraint-induced Movement Therapy	Behavioral: Modified Constraint-induced Movement Therapy Home based CIT Restriction of the less affected limb Intensive practice using affected limb Positive experience Functional task (task) Other Names: Constraint-Induced Therapy Forced-use Therapy Immobilization Therapy
Other: Transditional rehabilitation	Behavioral: Modified Constraint-induced Movement Therapy Home based CIT Restriction of the less affected limb Intensive practice using affected limb Positive experience Functional task (task) Other Names: Constraint-Induced Therapy Forced-use Therapy Immobilization Therapy

Arm

Intervention/Treatment

Experimental: Constraint-induced Movement Therapy

Behavioral: Modified Constraint-induced Movement Therapy

Home based CIT Restriction of the less affected limb Intensive practice using affected limb Positive experience Functional task (task)

Other Names:

Constraint-Induced Therapy

Forced-use Therapy

Immobilization Therapy

Other: Transditional rehabilitation

Behavioral: Modified Constraint-induced Movement Therapy

Home based CIT Restriction of the less affected limb Intensive practice using affected limb Positive experience Functional task (task)

Other Names:

Constraint-Induced Therapy

Forced-use Therapy

Immobilization Therapy

Outcome Measures

Primary Outcome Measures

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

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]