Constraint-induced Movement Therapy for Perinatal Brachial Plexus Injury

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

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.

Study Overview

• Status: Completed
• Conditions: Neonatal Brachial Plexus Palsy
• Intervention / Treatment: Behavioral: Constrain-induced Movement Therapy; Behavioral: Usual Occupational Therapy

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 Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 months to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Children's Hospital Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Actual): December 31, 2014
• Study Completion (Actual): December 31, 2014

Study Registration Dates

• First Submitted: December 3, 2018
• First Submitted That Met QC Criteria: December 4, 2018
• First Posted (Actual): December 5, 2018

Study Record Updates

• Last Update Posted (Actual): December 5, 2018
• Last Update Submitted That Met QC Criteria: December 4, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Infant, Newborn, Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Birth Injuries; Brachial Plexus Neuropathies; Neonatal Brachial Plexus Palsy
• Other Study ID Numbers: CCI-10-00255

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No