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N/A N=20 Randomized Triple-blind Treatment

NMES Efficacy on Patients With NBPP

Neonatal Brachial Plexus Palsy

Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcome: Primary: Change From Baseline in Upper Extremity Muscle Strength — 1; 1 score on a scale — p=0.40

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Standard NMES device (Device); Sham NMES device (Device)
Age
Pediatric · 0+ yrs
Sex
All
Sponsor
University of Michigan
Primary completion
Jan 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline in Upper Extremity Muscle Strength
1; 1 0.40
PRIMARY
Change From Baseline in Upper Extremity Range of Motion
55; 29 0.20

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.

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01999465). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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