NMES Efficacy on Patients With NBPP

NCT01999465 | Completed Results

• 1 other identifier: MedSAU-NMES
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Brachial Plexus Palsy

Keywords

Brachial plexus injury; Brachial plexus palsy; Neonate

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Upper Extremity Muscle Strength

  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.

  Baseline to 3-month.

• Change From Baseline in Upper Extremity Range of Motion

  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.

  Baseline to 3-month.

Other Outcomes (2)

• Change From Baseline in Spontaneous Hand-to-Mouth Movement

  Baseline to 3-month.

• Change From Baseline in Participant's Current Therapy

  Baseline to 3-month.

Study Arms (2)

Standard NMES cohort

ACTIVE COMPARATOR

Patients who will apply standard NMES device.

Device: Standard NMES device

Sham NMES cohort

SHAM COMPARATOR

Patients who will apply sham NMES device.

Device: Sham NMES device

Interventions

Standard NMES device 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)

Also known as: Neuromuscular electrical stimulation (NMES)

Standard NMES cohort

Sham NMES device 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)

Sham NMES cohort

Eligibility Criteria

• Age: 3 Months - 9 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• Spring Arbor University: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Neonatal Brachial Plexus Palsy

Condition Hierarchy (Ancestors)

Brachial Plexus Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Birth Injuries; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Wounds and Injuries

Results Point of Contact

• Title: Dr. Lynda Yang
• Organization: University of Michigan

bpclinic@umich.edu

7349365017

Study Officials

• Lynda Yang, MD, PhD

  Neurosurgery Department, University of Michigan Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: October 29, 2013
• First Posted: December 3, 2013
• Study Start: November 1, 2013
• Primary Completion: January 31, 2018
• Study Completion: January 31, 2018
• Last Updated: December 14, 2018
• Results First Posted: December 14, 2018

Record last verified: 2018-12

Locations

US (1)