NMES Efficacy on Patients With NBPP



Status:Completed
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:Any
Updated:12/16/2018
Start Date:November 2013
End Date:January 31, 2018

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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.

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. We will examine the British Medical Research Council (MRC) muscle
strength and participants' ability to perform active range of motion (AROM) movements.
Patients will be divided into two groups with one group receiving NMES and the other
receiving sham NMES. We plan to analyze the effects of this one treatment intervention of
NMES to determine if the device improves the function of the biceps muscle strength and
motion.

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
We found this trial at
1
site
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Lynda Yang, MD, PhD
Phone: 734-936-5017
University of Michigan The University of Michigan was founded in 1817 as one of the...
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mi
from
Ann Arbor, MI
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