NMES Efficacy on Patients With NBPP
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Standard NMES cohort Patients who will apply standard NMES device. |
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)
Other Names:
|
| Sham Comparator: Sham NMES cohort Patients who will apply sham NMES device. |
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)
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in Upper Extremity Muscle Strength [Baseline to 3-month.]
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.
- Change From Baseline in Upper Extremity Range of Motion [Baseline to 3-month.]
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.
Other Outcome Measures
- Change From Baseline in Spontaneous Hand-to-Mouth Movement [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.
- Change From Baseline in Participant's Current Therapy [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.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Michigan | Ann Arbor | Michigan | United States | 48109 |
Sponsors and Collaborators
- University of Michigan
- Spring Arbor University
Investigators
- Principal Investigator: Lynda Yang, MD, PhD, Neurosurgery Department, University of Michigan Health System
Study Documents (Full-Text)
More Information
Publications
None provided.- MedSAU-NMES
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Standard NMES Cohort | Sham NMES Cohort |
|---|---|---|
| Arm/Group Description | 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) | 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) |
| Period Title: Overall Study | ||
| STARTED | 10 | 10 |
| COMPLETED | 10 | 7 |
| NOT COMPLETED | 0 | 3 |
Baseline Characteristics
| Arm/Group Title | Standard NMES Cohort | Sham NMES Cohort | Total |
|---|---|---|---|
| Arm/Group Description | 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) | 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 of all reporting groups |
| Overall Participants | 10 | 7 | 17 |
| Age (months) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [months] |
4
(2)
|
4
(1)
|
4
(1)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
6
60%
|
6
85.7%
|
12
70.6%
|
| Male |
4
40%
|
1
14.3%
|
5
29.4%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
1
10%
|
0
0%
|
1
5.9%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
2
28.6%
|
2
11.8%
|
| White |
9
90%
|
5
71.4%
|
14
82.4%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
10
100%
|
7
100%
|
17
100%
|
| NBPP-involved side (Count of Participants) | |||
| Left |
5
50%
|
2
28.6%
|
7
41.2%
|
| Right |
5
50%
|
5
71.4%
|
10
58.8%
|
| Narakas (Count of Participants) | |||
| Narakas I-II |
8
80%
|
5
71.4%
|
13
76.5%
|
| Narakas III-IV |
2
20%
|
2
28.6%
|
4
23.5%
|
Outcome Measures
| Title | Change From Baseline in Upper Extremity Muscle Strength |
|---|---|
| Description | 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. |
| Time Frame | Baseline to 3-month. |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Standard NMES Cohort | Sham NMES Cohort |
|---|---|---|
| Arm/Group Description | 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) | 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) |
| Measure Participants | 9 | 5 |
| Median (Full Range) [score on a scale] |
1
|
1
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Standard NMES Cohort, Sham NMES Cohort |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.40 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | We applied Wilcoxon-Mann Whitney test with the Null hypothesis that there is no difference between 2 arms. | |
| Title | Change From Baseline in Upper Extremity Range of Motion |
|---|---|
| Description | 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. |
| Time Frame | Baseline to 3-month. |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Standard NMES Cohort | Sham NMES Cohort |
|---|---|---|
| Arm/Group Description | 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) | 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) |
| Measure Participants | 9 | 5 |
| Mean (Standard Deviation) [degree] |
55
(38)
|
29
(25)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Standard NMES Cohort, Sham NMES Cohort |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.20 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Title | Change From Baseline in Spontaneous Hand-to-Mouth Movement |
|---|---|
| Description | 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. |
| Time Frame | Baseline to 3-month. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Change From Baseline in Participant's Current Therapy |
|---|---|
| Description | 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. |
| Time Frame | Baseline to 3-month. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
Adverse Events
| Time Frame | 3 months | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Standard NMES Cohort | Sham NMES Cohort | ||
| Arm/Group Description | 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) | 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) | ||
All Cause Mortality |
||||
| Standard NMES Cohort | Sham NMES Cohort | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/10 (0%) | 0/7 (0%) | ||
Serious Adverse Events |
||||
| Standard NMES Cohort | Sham NMES Cohort | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/10 (0%) | 0/7 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Standard NMES Cohort | Sham NMES Cohort | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/10 (0%) | 0/7 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Lynda Yang |
|---|---|
| Organization | University of Michigan |
| Phone | 7349365017 |
| bpclinic@umich.edu |
- MedSAU-NMES