Clinical trial NCT01999465: NMES Efficacy on Patients With NBPP
Official title: Neuromuscular Electrical Stimulation (NMES) Efficacy on Patients With Neonatal Brachial Plexus Palsy (NBPP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Brachial Plexus Palsy
Keywords: Brachial plexus injury
Brachial plexus palsy
Neonate
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Spring Arbor University
First posted: 2013-12-03
Enrollment: 20
Sex: ALL
Minimum age (years): 3
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Upper Extremity Muscle Strength
timeFrame: Baseline to 3-month.
measure: Change From Baseline in Upper Extremity Range of Motion
timeFrame: Baseline to 3-month.
Secondary outcomes:
Other outcomes:
measure: Change From Baseline in Spontaneous Hand-to-Mouth Movement
timeFrame: Baseline to 3-month.
measure: Change From Baseline in Participant's Current Therapy
timeFrame: Baseline to 3-month.
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: Neurosurgery Department, University of Michigan Health System
name: Lynda Yang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: