Constraint-induced Movement Therapy for Perinatal Brachial Plexus Injury

Not Applicable

Completed

• Conditions: Neonatal Brachial Plexus Palsy
• Interventions: Behavioral: Constrain-induced Movement Therapy; Behavioral: Usual Occupational Therapy

• Registration Number: NCT03765034
• Lead Sponsor: Children's Hospital Los Angeles

Brief Summary

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

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 Timeline

• Study Start: 2010-01-01
• Primary Completion: 2014-12-31
• Study Completion: 2014-12-31
• Status Verified: 2018-12
• Study First Submitted: 2018-12-03
• Study First Submitted QC: 2018-12-04
• Last Update Submitted: 2018-12-04
• Study First Posted: 2018-12-05
• Last Update Posted: 2018-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Constraint-induced Movement Therapy	Usual Occupational Therapy	A passive constraint cast is applied to the participant's unaffected arm to prevent use for 8 weeks.
Constraint-induced Movement Therapy	Constrain-induced Movement Therapy	A passive constraint cast is applied to the participant's unaffected arm to prevent use for 8 weeks.
Usual Occupational Therapy	Usual Occupational Therapy	Usual and standard care occupational therapy is administered for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Assisting Hand Assessment 5.0	change from baseline at 8 weeks and 16 weeks	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.