NMES Efficacy on Patients With NBPP

Not Applicable

Completed

• Conditions: Neonatal Brachial Plexus Palsy
• Interventions: Device: Sham NMES device; Device: Standard NMES device

• Registration Number: NCT01999465
• Lead Sponsor: University of Michigan

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.

Study Timeline

• Study First Submitted: 2013-10-29
• Study Start: 2013-11
• Study First Submitted QC: 2013-11-25
• Study First Posted: 2013-12-03
• Primary Completion: 2018-01-31
• Study Completion: 2018-01-31
• Results First Submitted: 2018-11-16
• Status Verified: 2018-12
• Results First Submitted QC: 2018-12-12
• Last Update Submitted: 2018-12-12
• Results First Posted: 2018-12-14
• Last Update Posted: 2018-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham NMES cohort	Sham NMES device	Patients who will apply sham NMES device.
Standard NMES cohort	Standard NMES device	Patients who will apply standard NMES device.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Upper Extremity Muscle Strength	Baseline to 3-month.	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.
Change From Baseline in Upper Extremity Range of Motion	Baseline to 3-month.	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.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States