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

NCT ID: NCT01076257

Last Updated: 2012-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-07-31

Brief Summary

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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

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"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.

Conditions

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Brain Damage Cerebral Palsy Traumatic Brain Damage

Keywords

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brain damage constraint induced movement therapy kinematic function outcome Quality of life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Constraint-induced Movement Therapy

Group Type EXPERIMENTAL

Modified Constraint-induced Movement Therapy

Intervention Type BEHAVIORAL

Home based CIT

1. Restriction of the less affected limb
2. Intensive practice using affected limb
3. Positive experience
4. Functional task (task)

Transditional rehabilitation

Group Type OTHER

Modified Constraint-induced Movement Therapy

Intervention Type BEHAVIORAL

Home based CIT

1. Restriction of the less affected limb
2. Intensive practice using affected limb
3. Positive experience
4. Functional task (task)

Interventions

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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)

Intervention Type BEHAVIORAL

Other Intervention Names

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Constraint-Induced Therapy Forced-use Therapy Immobilization Therapy

Eligibility Criteria

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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)
Minimum Eligible Age

4 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chia-Ling chen, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Locations

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Chang Gung Memorial Hospital

Taoyuan District, Taoyuan, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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97-1823B

Identifier Type: -

Identifier Source: org_study_id