Trial record 7 of 30 for:    Brachial Plexus Injuries

NMES Efficacy on Patients With NBPP

This study is not yet open for participant recruitment.
Verified November 2013 by University of Michigan
Sponsor:
Collaborator:
Spring Arbor University
Information provided by (Responsible Party):
Lynda Yang, University of Michigan
ClinicalTrials.gov Identifier:
NCT01999465
First received: October 29, 2013
Last updated: November 25, 2013
Last verified: November 2013
  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.


Condition Intervention Phase
Neonatal Brachial Plexus Palsy
Device: Standard NMES device
Device: Sham NMES device
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Neuromuscular Electrical Stimulation (NMES) Efficacy on Patients With Neonatal Brachial Plexus Palsy (NBPP)

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Change from Baseline in Upper Extremity Muscle Strength and Range of Motion [ Time Frame: At 0. 1, 2 and 3 month ] [ Designated as safety issue: No ]
    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:
  • Change from Baseline in Participant's Current Therapy [ Time Frame: At 0. 1, 2 and 3 month ] [ Designated as safety issue: No ]
    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:
  • Change from Baseline in Spontaneous Hand-to-Mouth Movement [ Time Frame: At 0. 1, 2 and 3 month ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 30
Study Start Date: November 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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

  Eligibility

Ages Eligible for Study:   3 Months to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01999465

Locations
United States, Michigan
University of Michigan Not yet recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Connie McGovern    734-936-5017    bpclinic@umich.edu   
Contact: Kate Chang, MA    7346156550    katewc@med.umich.edu   
Principal Investigator: Lynda Yang, MD, PhD         
Sponsors and Collaborators
University of Michigan
Spring Arbor University
Investigators
Principal Investigator: Lynda Yang, MD, PhD Neurosurgery Department, University of Michigan Health System
  More Information

No publications provided

Responsible Party: Lynda Yang, MD, PhD, University of Michigan
ClinicalTrials.gov Identifier: NCT01999465     History of Changes
Other Study ID Numbers: MedSAU-NMES
Study First Received: October 29, 2013
Last Updated: November 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Brachial plexus injury
Brachial plexus palsy
Neonate

Additional relevant MeSH terms:
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014