Trial Outcomes & Findings for NMES Efficacy on Patients With NBPP (NCT NCT01999465)
NCT ID: NCT01999465
Last Updated: 2018-12-14
Results Overview
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.
COMPLETED
NA
20 participants
Baseline to 3-month.
2018-12-14
Participant Flow
Participant milestones
| Measure |
Standard NMES Cohort
Patients who will apply standard NMES device.
Standard NMES 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)
|
Sham NMES Cohort
Patients who will apply sham NMES device.
Sham NMES 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)
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
Standard NMES Cohort
Patients who will apply standard NMES device.
Standard NMES 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)
|
Sham NMES Cohort
Patients who will apply sham NMES device.
Sham NMES 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)
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
NMES Efficacy on Patients With NBPP
Baseline characteristics by cohort
| Measure |
Standard NMES Cohort
n=10 Participants
Patients who will apply standard NMES device.
Standard NMES 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)
|
Sham NMES Cohort
n=7 Participants
Patients who will apply sham NMES device.
Sham NMES 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)
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
4 months
STANDARD_DEVIATION 2 • n=93 Participants
|
4 months
STANDARD_DEVIATION 1 • n=4 Participants
|
4 months
STANDARD_DEVIATION 1 • n=27 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=93 Participants
|
7 participants
n=4 Participants
|
17 participants
n=27 Participants
|
|
NBPP-involved side
Left
|
5 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
NBPP-involved side
Right
|
5 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Narakas
Narakas I-II
|
8 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Narakas
Narakas III-IV
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline to 3-month.Population: One in the Standard NMES cohort was lost of follow-up and two in the sham cohort were lost of follow-up at 3 months.
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.
Outcome measures
| Measure |
Standard NMES Cohort
n=9 Participants
Patients who will apply standard NMES device.
Standard NMES 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)
|
Sham NMES Cohort
n=5 Participants
Patients who will apply sham NMES device.
Sham NMES 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)
|
|---|---|---|
|
Change From Baseline in Upper Extremity Muscle Strength
|
1 score on a scale
Interval 0.0 to 5.0
|
1 score on a scale
Interval 0.0 to 5.0
|
PRIMARY outcome
Timeframe: Baseline to 3-month.Population: One in the Standard NMES cohort was lost of follow-up and two in the sham cohort were lost of follow-up at 3 months.
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.
Outcome measures
| Measure |
Standard NMES Cohort
n=9 Participants
Patients who will apply standard NMES device.
Standard NMES 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)
|
Sham NMES Cohort
n=5 Participants
Patients who will apply sham NMES device.
Sham NMES 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)
|
|---|---|---|
|
Change From Baseline in Upper Extremity Range of Motion
|
55 degree
Standard Deviation 38
|
29 degree
Standard Deviation 25
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 3-month.Study coordinators will conduct one-minute video recording with patient in supported sitting position in a chair or seated on parents lap at initial and monthly clinic visits. A toy, pacifier, or bottle will be provided to trigger patient's spontaneous hand-to-mouth movement. The frequency of hand to mouth motion will be recorded and separated out as to the positioning of the elbow. We are evaluating the motion to determine if the motion of the elbow flexion is against gravity, (the arm held at the side of the body or in an adducted position) or in gravity-eliminated position, (the arm held away from the body or in an abducted position). We are looking at the strength of the biceps in its ability to lift the arm against gravity during functional hand to mouth activities. The NMES unit will not be in use during the videotaping process; we are looking at the spontaneous movement of the extremity.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 3-month.Parents will complete a survey asking participant's current therapy program, including therapy type, setting, frequency, duration, other treatment activities, splint usage, home range of motion exercise program and its frequency and duration at initial and monthly follow-up visits. The purpose of this survey is to help us understand whether there are potential confounders that could affect the study result.
Outcome measures
Outcome data not reported
Adverse Events
Standard NMES Cohort
Sham NMES Cohort
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place