Back to resultsConstraint-induced Movement Therapy for Perinatal Brachial Plexus Injury
Primary Purpose
Neonatal Brachial Plexus Palsy
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Constrain-induced Movement Therapy
Usual Occupational Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Neonatal Brachial Plexus Palsy
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Constraint-induced Movement Therapy
Usual Occupational Therapy
Arm Description
A passive constraint cast is applied to the participant's unaffected arm to prevent use for 8 weeks.
Usual and standard care occupational therapy is administered for 8 weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03765034
First Posted
December 3, 2018
Last Updated
December 4, 2018
Sponsor
Children's Hospital Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT03765034
Brief Title
Constraint-induced Movement Therapy for Perinatal Brachial Plexus Injury
Official Title
Constraint-Induced Movement Therapy and Occupational Therapy for Perinatal Brachial Plexus Injury: A Randomized Crossover Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2010 (Actual)
Primary Completion Date
December 31, 2014 (Actual)
Study Completion Date
December 31, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital Los Angeles
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Brachial Plexus Palsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Constraint-induced Movement Therapy
Arm Type
Experimental
Arm Description
A passive constraint cast is applied to the participant's unaffected arm to prevent use for 8 weeks.
Arm Title
Usual Occupational Therapy
Arm Type
Active Comparator
Arm Description
Usual and standard care occupational therapy is administered for 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Constrain-induced Movement Therapy
Intervention Description
8-week therapy program utilizing constraint of the unaffected arm
Intervention Type
Behavioral
Intervention Name(s)
Usual Occupational Therapy
Intervention Description
8-week therapy program without constraint of the unaffected arm
Primary Outcome Measure Information:
Title
Assisting Hand Assessment 5.0
Description
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.
Time Frame
change from baseline at 8 weeks and 16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Constraint-induced Movement Therapy for Perinatal Brachial Plexus Injury
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