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Constraint-induced Movement Therapy for Perinatal Brachial Plexus Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03765034
Recruitment Status : Completed
First Posted : December 5, 2018
Last Update Posted : December 5, 2018
Information provided by (Responsible Party):
julie werner, 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.

Condition or disease Intervention/treatment Phase
Neonatal Brachial Plexus Palsy Behavioral: Constrain-induced Movement Therapy Behavioral: Usual Occupational Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Constraint-Induced Movement Therapy and Occupational Therapy for Perinatal Brachial Plexus Injury: A Randomized Crossover Trial
Actual Study Start Date : January 1, 2010
Actual Primary Completion Date : December 31, 2014
Actual Study Completion Date : December 31, 2014

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

Primary Outcome Measures :
  1. Assisting Hand Assessment 5.0 [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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Responsible Party: julie werner, Clinical Scientist, Children's Hospital Los Angeles Identifier: NCT03765034     History of Changes
Other Study ID Numbers: CCI-10-00255
First Posted: December 5, 2018    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neonatal Brachial Plexus Palsy
Brachial Plexus Neuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Birth Injuries
Infant, Newborn, Diseases
Wounds and Injuries