Constraint-induced Movement Therapy for Perinatal Brachial Plexus Injury

NCT03765034 | Completed

• 1 other identifier: CCI-10-00255
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neonatal Brachial Plexus Palsy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Constraint-induced Movement Therapy

EXPERIMENTAL

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

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

Usual Occupational Therapy

ACTIVE COMPARATOR

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

Behavioral: Usual Occupational Therapy

Interventions

Constrain-induced Movement Therapy BEHAVIORAL

8-week therapy program utilizing constraint of the unaffected arm

Constraint-induced Movement Therapy

Usual Occupational Therapy BEHAVIORAL

8-week therapy program without constraint of the unaffected arm

Constraint-induced Movement Therapy; Usual Occupational Therapy

Eligibility Criteria

• Age: 12 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead

MeSH Terms

Conditions

Neonatal Brachial Plexus Palsy

Condition Hierarchy (Ancestors)

Brachial Plexus Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Birth Injuries; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Scientist

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: December 5, 2018
• Study Start: January 1, 2010
• Primary Completion: December 31, 2014
• Study Completion: December 31, 2014
• Last Updated: December 5, 2018

Record last verified: 2018-12