Constraint-induced Movement Therapy for Perinatal Brachial Plexus Injury

Children's Hospital Los Angeles22 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Neonatal Brachial Plexus Palsy

Interventions

Constrain-induced Movement TherapyBEHAVIORAL

8-week therapy program utilizing constraint of the unaffected arm

Usual Occupational TherapyBEHAVIORAL

8-week therapy program without constraint of the unaffected arm

Eligibility

Sex: ALLMin age: 12 MonthsMax age: 5 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: change from baseline at 8 weeks and 16 weeks

Data from ClinicalTrials.gov

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