NMES Efficacy on Patients With NBPP

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01999465
Recruitment Status : Completed
First Posted : December 3, 2013
Last Update Posted : February 5, 2018
Spring Arbor University
Information provided by (Responsible Party):
Lynda Yang, 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 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.

Condition or disease Intervention/treatment Phase
Neonatal Brachial Plexus Palsy Device: Standard NMES device Device: Sham NMES device Not Applicable

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. 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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Neuromuscular Electrical Stimulation (NMES) Efficacy on Patients With Neonatal Brachial Plexus Palsy (NBPP)
Actual Study Start Date : November 2013
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Paralysis
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Standard NMES cohort
Patients who will apply standard NMES device.
Device: Standard NMES device

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.

  • Rate(35 Hz)
  • Width (300 us)
  • Ch1 Ramp+ (2 seconds)
  • On Time 1 (10 seconds)
  • Ch1 Ramp - (2 seconds)
Other Name: Neuromuscular electrical stimulation (NMES)
Sham Comparator: Sham NMES cohort
Patients who will apply sham NMES device.
Device: Sham NMES device

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.

  • Rate(35 Hz)
  • Width (48 us)
  • Ch1 Ramp+ (0 seconds)
  • On Time 1 (0 seconds)
  • Ch1 Ramp - (0 seconds)

Primary Outcome Measures :
  1. Change from Baseline in Upper Extremity Muscle Strength and Range of Motion [ Time Frame: At 0. 1, 2 and 3 month ]
    One of the two-blinded occupational therapists will conduct the evaluation at enrollment and each follow-up clinic visit. In this study, we will evaluate the biceps strength using the MRC grading system and the active elbow flexion using a goniometer. The MRC grading system for muscle strength is based on a scale from 0 (not testable) to 5 (normal strength). MRC grade 3 or higher is functional in terms of muscle power.

Secondary Outcome Measures :
  1. Change from Baseline in Participant's Current Therapy [ Time Frame: At 0. 1, 2 and 3 month ]
    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.

Other Outcome Measures:
  1. Change from Baseline in Spontaneous Hand-to-Mouth Movement [ Time Frame: At 0. 1, 2 and 3 month ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01999465

United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Spring Arbor University
Principal Investigator: Lynda Yang, MD, PhD Neurosurgery Department, University of Michigan Health System

Responsible Party: Lynda Yang, MD, PhD, University of Michigan Identifier: NCT01999465     History of Changes
Other Study ID Numbers: MedSAU-NMES
First Posted: December 3, 2013    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: February 2018

Keywords provided by Lynda Yang, University of Michigan:
Brachial plexus injury
Brachial plexus palsy