Constraint-induced Movement Therapy for Perinatal Brachial Plexus Injury

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

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-01

Study Completion Date

2014-12-31

Brief Summary

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This study evaluates the addition of constraint-induced movement therapy (CIMT) to usual care occupational therapy in children with perinatal brachial plexus injury. Participants are randomized to receive either the intervention (CIMT) or control first, then cross over to receive the other one.

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Detailed Description

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Children with perinatal brachial plexus injury routinely receive occupational therapy intervention to improve strength and function in their weak or paralyzed arm.

Constraint-induced movement therapy (CIMT) is known to increase upper extremity function in children with weakness or disuse as a result of cerebral palsy. However, it is unknown if this therapy is effective for treating arm weakness or disuse as a result of perinatal brachial plexus injury. The addition of CIMT to usual and standard occupational therapy care is evaluated in this trial.

Conditions

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Neonatal Brachial Plexus Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Constraint-induced Movement Therapy

A passive constraint cast is applied to the participant's unaffected arm to prevent use for 8 weeks.

Group Type EXPERIMENTAL

Constrain-induced Movement Therapy

Intervention Type BEHAVIORAL

8-week therapy program utilizing constraint of the unaffected arm

Usual Occupational Therapy

Intervention Type BEHAVIORAL

8-week therapy program without constraint of the unaffected arm

Usual Occupational Therapy

Usual and standard care occupational therapy is administered for 8 weeks.

Group Type ACTIVE_COMPARATOR

Usual Occupational Therapy

Intervention Type BEHAVIORAL

8-week therapy program without constraint of the unaffected arm

Interventions

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Constrain-induced Movement Therapy

8-week therapy program utilizing constraint of the unaffected arm

Intervention Type BEHAVIORAL

Usual Occupational Therapy

8-week therapy program without constraint of the unaffected arm

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Participant has perinatal brachial plexus injury
* Participant walking at time of study inception
* Ability to cooperate with interventions and assessment
* Participant currently receiving occupational therapy 1+ hour per week and planning to continue for duration of study

Exclusion Criteria

* Co-morbid diagnosis not related to perinatal brachial plexus injury
* Flaccidity of the involved upper extremity or no observable hand function
* Planned surgery or drug intervention during the study period
* Allergy or intolerance to constraint intervention materials

Minimum Eligible Age

12 Months

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No