Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2013-11-30
2018-01-31
Brief Summary
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In the case of NBPP patients, the loss in normal arm function can be observed very early. Young patients will often neglect using the affected arm or modify motions to avoid the use of the biceps muscle, specifically in hand to mouth actions such as gripping a bottle or placing toys or other objects in the mouth. A goal of this study is to test the effectiveness of NMES on improving the biceps muscle Medical Research Council (MRC) strength and active range of motion (AROM).
The subjects of this study are newborns between the ages of 3-9 months who are already a part of the University of Michigan Brachial Plexus program. Parents of the children will be trained to perform the neuromuscular electrical stimulation therapy at home using the EMPI Continuum unit for 30 minutes each day and monthly follow up appointments will be performed be the research occupational therapists throughout three month study period.
Parents of the participants will complete a questionnaire before and during the study period to help analyze for confounders and gather data regarding parent compliance and NMES effectiveness. To detect the effectiveness of NMES, two cohort groups using standard units and sham units will be recruited and compare with data analysis.
The investigators predict that the NMES will effectively improve the ability of the neonate to increase use of the affected arm, specifically in muscle strength biceps MRC score and AROM.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Standard NMES cohort
Patients who will apply standard NMES device.
Standard NMES device
Blinded parents will follow the NMES parent instructions and place the NMES on the biceps muscle of their child for 30 minutes every day for three months.
* Rate(35 Hz)
* Width (300 us)
* Ch1 Ramp+ (2 seconds)
* On Time 1 (10 seconds)
* Ch1 Ramp - (2 seconds)
Sham NMES cohort
Patients who will apply sham NMES device.
Sham NMES device
Blinded parents will follow the NMES parent instructions and place the NMES on the biceps muscle of their child for 30 minutes every day for three months.
* Rate(35 Hz)
* Width (48 us)
* Ch1 Ramp+ (0 seconds)
* On Time 1 (0 seconds)
* Ch1 Ramp - (0 seconds)
Interventions
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Standard NMES device
Blinded parents will follow the NMES parent instructions and place the NMES on the biceps muscle of their child for 30 minutes every day for three months.
* Rate(35 Hz)
* Width (300 us)
* Ch1 Ramp+ (2 seconds)
* On Time 1 (10 seconds)
* Ch1 Ramp - (2 seconds)
Sham NMES device
Blinded parents will follow the NMES parent instructions and place the NMES on the biceps muscle of their child for 30 minutes every day for three months.
* Rate(35 Hz)
* Width (48 us)
* Ch1 Ramp+ (0 seconds)
* On Time 1 (0 seconds)
* Ch1 Ramp - (0 seconds)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* NBPP patients who receive care from University Of Michigan Brachial Plexus Palsy clinic
* All gender/race/financial backgrounds
* active range of motion (AROM) elbow flexion \<150°
* All Narakas grades
* British Medical Research Council (MRC) grade 2- or 4 for biceps brachii
Exclusion Criteria
* Patients with any existing secondary medical conditions
* Patients with elbow contracture greater than 5°
* British Medical Research Council (MRC) grade 5 for biceps brachii
* active range of motion (AROM) elbow flexion =150°
* Non-English speaking families
* Children already using NMES unit
3 Months
9 Months
ALL
No
Sponsors
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Spring Arbor University
UNKNOWN
University of Michigan
OTHER
Responsible Party
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Lynda Yang
MD, PhD
Principal Investigators
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Lynda Yang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Neurosurgery Department, University of Michigan Health System
Locations
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University of Michigan
Ann Arbor, Michigan, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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MedSAU-NMES
Identifier Type: -
Identifier Source: org_study_id