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NCT01999465 · ClinicalTrials.gov registry record · NA
NMES Efficacy on Patients With NBPP
A NA study of Neonatal Brachial Plexus Palsy, sponsored by University of Michigan.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT01999465 is a NA study of Neonatal Brachial Plexus Palsy that has completed, run by University of Michigan. The registered enrollment target is 20 participants. The trial reports 1 study location across 1 state.
The verdict
NCT01999465, a NA study of Neonatal Brachial Plexus Palsy, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- DEVICE Standard NMES device
- DEVICE Sham NMES device
Study Locations (1)
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2013-11 |
| Est. Completion | 2018-01-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01999465
The ClinicalTrials.gov registry entry for NCT01999465 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Neonatal Brachial Plexus Palsy appearing as the primary indexed condition, and to 2 interventions - of which Standard NMES device is the first listed.
NCT01999465 reports 1 study location spanning 1 distinct geographic area - top geographies include Michigan.
Frequently Asked Questions
What is clinical trial NCT01999465 about?
NCT01999465 is a clinical study titled "NMES Efficacy on Patients With NBPP". 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 as...
What is the current status of trial NCT01999465?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2013-11. Estimated completion is 2018-01-31.
What conditions does trial NCT01999465 study?
This clinical trial studies the following conditions: Neonatal Brachial Plexus Palsy.
What interventions are being tested in trial NCT01999465?
The interventions under investigation include: Standard NMES device (DEVICE), Sham NMES device (DEVICE).
Who is sponsoring clinical trial NCT01999465?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01999465 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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