- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01999465
NMES Efficacy on Patients With NBPP
Neuromuscular Electrical Stimulation (NMES) Efficacy on Patients With Neonatal Brachial Plexus Palsy (NBPP)
Neonatal Brachial Plexus Palsy (NBPP), characterized by weakness and sensory loss in the affected arm, results from damage in the prenatal period to the nerves extending from the spine to the arm. Proper stretching and exercise of the joints and affected arm from the time of diagnosis can greatly assist in the development of healthy movement of the limb. Additionally, neuromuscular electrical stimulation has been shown to be an effective treatment in other neural disorders and therefore its effectiveness in NBPP is worth studying.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Children ages 3-9 months at time of enrollment
- 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:
- Brachial Plexus patients require needing surgical repair
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Standard NMES cohort
Patients who will apply standard NMES device.
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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.
Other Names:
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Sham Comparator: Sham NMES cohort
Patients who will apply sham NMES device.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Upper Extremity Muscle Strength
Time Frame: Baseline to 3-month.
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One of the two-blinded occupational therapists will conduct the evaluation at enrollment and 3-month follow-up clinic visit.
In this study, we will evaluate the biceps strength using the British Medical Research Council (MRC) grading system.
The British Medical Research Council (MRC) grading system for muscle strength is based on a scale from 0 (minimum score, not testable), 1, 2, 3, 4, to 5 (maximum score, normal strength); higher score means better outcome.
British Medical Research Council (MRC) grade 2 or higher is functional in terms of muscle power.
In current study, we will examine the change of biceps British Medical Research Council (MRC) grade from baseline to 3-month.
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Baseline to 3-month.
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Change From Baseline in Upper Extremity Range of Motion
Time Frame: Baseline to 3-month.
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One of the two-blinded occupational therapists will assess the active range of motion (AROM) of elbow flexion using goniometer at enrollment and 3-month follow-up clinic visit.
The minimum degree is 0 and the maximum degree is 150; the higher degree means better outcome.
We will then examine the change of elbow flexion active range of motion (AROM) from baseline to 3-month.
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Baseline to 3-month.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Spontaneous Hand-to-Mouth Movement
Time Frame: Baseline to 3-month.
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Study coordinators will conduct one-minute video recording with patient in supported sitting position in a chair or seated on parents lap at initial and monthly clinic visits.
A toy, pacifier, or bottle will be provided to trigger patient's spontaneous hand-to-mouth movement.
The frequency of hand to mouth motion will be recorded and separated out as to the positioning of the elbow.
We are evaluating the motion to determine if the motion of the elbow flexion is against gravity, (the arm held at the side of the body or in an adducted position) or in gravity-eliminated position, (the arm held away from the body or in an abducted position).
We are looking at the strength of the biceps in its ability to lift the arm against gravity during functional hand to mouth activities.
The NMES unit will not be in use during the videotaping process; we are looking at the spontaneous movement of the extremity.
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Baseline to 3-month.
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Change From Baseline in Participant's Current Therapy
Time Frame: Baseline to 3-month.
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Parents will complete a survey asking participant's current therapy program, including therapy type, setting, frequency, duration, other treatment activities, splint usage, home range of motion exercise program and its frequency and duration at initial and monthly follow-up visits.
The purpose of this survey is to help us understand whether there are potential confounders that could affect the study result.
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Baseline to 3-month.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Lynda Yang, MD, PhD, Neurosurgery Department, University of Michigan Health System
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MedSAU-NMES
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neonatal Brachial Plexus Palsy
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University of British ColumbiaChildren's & Women's Health Centre of British ColumbiaTerminated
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University of British ColumbiaChildren's & Women's Health Centre of British ColumbiaWithdrawnBirth Related Brachial Plexus Injury | Obstetrical Brachial Plexus Palsy
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University Hospital, MontpellierCompletedObstetrical Brachial Plexus PalsyFrance
-
University Hospital, MontpellierPhyMedExp Inserm U1046RecruitingObstetrical Brachial Plexus PalsyFrance
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University Hospital, BrestRecruitingObstetrical Brachial Plexus PalsyFrance
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Children's Hospital Los AngelesCompletedNeonatal Brachial Plexus Palsy
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CEU San Pablo UniversityCompleted
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University Hospital, GhentCompletedNeonatal Brachial Plexus PalsyBelgium
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Chapman UniversityAmerican Society for Surgery of the HandUnknownBrachial Plexus PalsyUnited States
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