NMES Efficacy on Patients With NBPP
Condition: Neonatal Brachial Plexus Palsy
MeSH terms: Neonatal Brachial Plexus Palsy
Study type: Interventional

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.
    

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. We will examine the British Medical Research Council (MRC) muscle
      strength and participants' ability to perform active range of motion (AROM) movements.
      Patients will be divided into two groups with one group receiving NMES and the other
      receiving sham NMES. We plan to analyze the effects of this one treatment intervention of
      NMES to determine if the device improves the function of the biceps muscle strength and
      motion.
    

Intervention name(s): Standard NMES device; Sham NMES device
Intervention type(s): Device; Device
Intervention description(s): 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); 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)
Other intervention name(s): Neuromuscular electrical stimulation (NMES)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Brachial plexus injury; Brachial plexus palsy; Neonate