Constraint-induced Movement Therapy for Perinatal Brachial Plexus Injury

Children's Hospital Los Angeles

Status: Completed

Conditions: Neonatal Brachial Plexus Palsy

Treatments: Behavioral: Constrain-induced Movement Therapy; Behavioral: Usual Occupational Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03765034

CCI-10-00255

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 12 months to 5 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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22 participants in 2 patient groups

Constraint-induced Movement Therapy

Experimental group

Description:

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

Treatment:

Behavioral: Constrain-induced Movement Therapy

Behavioral: Usual Occupational Therapy

Usual Occupational Therapy

Active Comparator group

Description:

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

Treatment:

Behavioral: Usual Occupational Therapy