NMES Efficacy on Patients With NBPP

Completed · Not applicable · Has a placebo group

Conditions studied: Neonatal Brachial Plexus Palsy

In brief

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.

Key facts

Study ID
NCT01999465
Run by
University of Michigan
People needed
20
Starts
2013-11-01
Expected to finish
2018-01-31
Last updated by the study team
2018-12-14

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

You may not qualify if…

Where it is running

Full record on ClinicalTrials.gov

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