Neonatal Brachial Plexus Palsy
Conditions
Keywords
Brachial plexus injury, Brachial plexus palsy, Neonate
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.
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.
Interventions
DEVICEStandard 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)
DEVICESham 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)
Sponsors
Spring Arbor University
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Months to 9 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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) | 10 |
| 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) | 7 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 2 |
| Overall Study | Protocol Violation | 0 | 1 |
Baseline characteristics
| Characteristic | Sham NMES Cohort | Standard NMES Cohort | Total |
|---|---|---|---|
| Age, Continuous | 4 months STANDARD_DEVIATION 1 | 4 months STANDARD_DEVIATION 2 | 4 months STANDARD_DEVIATION 1 |
| Narakas Narakas I-II | 5 Participants | 8 Participants | 13 Participants |
| Narakas Narakas III-IV | 2 Participants | 2 Participants | 4 Participants |
| NBPP-involved side Left | 2 Participants | 5 Participants | 7 Participants |
| NBPP-involved side Right | 5 Participants | 5 Participants | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 9 Participants | 14 Participants |
| Region of Enrollment United States | 7 participants | 10 participants | 17 participants |
| Sex: Female, Male Female | 6 Participants | 6 Participants | 12 Participants |
| Sex: Female, Male Male | 1 Participants | 4 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 7 |
| other Total, other adverse events | 0 / 10 | 0 / 7 |
| serious Total, serious adverse events | 0 / 10 | 0 / 7 |
Outcome results
Primary
Change From Baseline in Upper Extremity Muscle Strength
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.
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard NMES Cohort | Change From Baseline in Upper Extremity Muscle Strength | 1 score on a scale |
| Sham NMES Cohort | Change From Baseline in Upper Extremity Muscle Strength | 1 score on a scale |
p-value: 0.4Wilcoxon (Mann-Whitney)
Primary
Change From Baseline in Upper Extremity Range of Motion
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.
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard NMES Cohort | Change From Baseline in Upper Extremity Range of Motion | 55 degree | Standard Deviation 38 |
| Sham NMES Cohort | Change From Baseline in Upper Extremity Range of Motion | 29 degree | Standard Deviation 25 |
p-value: 0.2t-test, 2 sided
Other Pre-specified
Change From Baseline in Participant's Current Therapy
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.
Other Pre-specified
Change From Baseline in Spontaneous Hand-to-Mouth Movement
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.