Ann Arbor, Michigan 48109


Purpose:

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 the biceps muscle in improving the participant's ability to perform normal hand to mouth actions. Additionally, biceps muscle Medical Research Council (MRC) strength and active range of motion (AROM) will be tested to examine the increase of useful arm movement. The subjects of this study are newborns between the ages of 3-6 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 hand to mouth movements and other aspects of biceps MRC score and AROM.


Study summary:

The purpose of this study is to investigate whether the use of Neuromuscular Electrical Stimulation (NMES), via the Empi® Continuum unit, will improve the ability with which children with Neonatal Brachial Plexus Palsy (NBPP) are able to use their biceps muscle in activities of daily living. The investigators intend to measure how the NMES will aid the patients in using the affected arm to perform routine activities like bringing the hand or bottle to their mouth. Additionally, the investigators will examine the muscle strength and participants' ability to perform active range of motion (AROM) movements. Patients will be divided into cohort groups with one group receiving NMES and the other receiving sham NMES. The investigators plan to analyze the effects of this one treatment intervention of NMES to determine if the device improves the function of the biceps muscle for motion, strength and functional activities


Criteria:

Inclusion Criteria: - Children ages 3-6 months at time of enrollment - NBPP patients who receive care from University Of Michigan Brachial Plexus Palsy clinic - All gender/race/financial backgrounds - AROM elbow flexion <150° - All Narakas grades - MRC grade 3 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° - MRC grade 5 for biceps brachii - AROM elbow flexion =150° - Non-English speaking families - Children already using NMES unit


NCT ID:

NCT01999465


Primary Contact:

Principal Investigator
Lynda Yang, MD, PhD
Neurosurgery Department, University of Michigan Health System


Backup Contact:

N/A


Location Contact:

Ann Arbor, Michigan 48109
United States

Connie McGovern
Phone: 734-936-5017
Email: bpclinic@umich.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 22, 2017

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