Constraint-induced Movement Therapy for Perinatal Brachial Plexus Injury

Study Overview
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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.

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.

Official Title
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Constraint-Induced Movement Therapy and Occupational Therapy for Perinatal Brachial Plexus Injury: A Randomized Crossover Trial

Conditions
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Neonatal Brachial Plexus Palsy

Intervention / Treatment
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* Behavioral: Constrain-induced Movement Therapy
* Behavioral: Usual Occupational Therapy


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Constraint-induced Movement Therapy<br>A passive constraint cast is applied to the participant's unaffected arm to prevent use for 8 weeks. | Behavioral: Constrain-induced Movement Therapy<br>* 8-week therapy program utilizing constraint of the unaffected arm<br>Behavioral: Usual Occupational Therapy<br>* 8-week therapy program without constraint of the unaffected arm<br>|
| Active Comparator: Usual Occupational Therapy<br>Usual and standard care occupational therapy is administered for 8 weeks. | Behavioral: Usual Occupational Therapy<br>* 8-week therapy program without constraint of the unaffected arm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assisting Hand Assessment 5.0 | Criterion-referenced observational scale of affected hand use during bimanual performance. Each item is score 1-4 (1 = does not do; 2 = ineffective; 3 = somewhat effective; 4 = effective), yielding a Rasch-modeled standardized score between 0 and 100. | change from baseline at 8 weeks and 16 weeks |