Effect of Neuromuscular Electrical Stimulation on the Post-Operative Abdominoplasty Patient.

Study Overview
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Brief Summary
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The purpose of this study is to determine the impact of rehabilitative training of the abdominal wall with direct current neuromuscular electrical stimulation (the NEUBIE device) on recovery time from abdominoplasty (tummy tuck).

Detailed Description
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Participants will undergo abdominoplasty surgery and begin rehabilitation training within the first week post-operation. Standardized measurements of recovery progress will be taken starting prior to operation, and at 2, 4, 6, 8 and 12 weeks post-operation. Participants will undergo either the traditional standard of care of rest, with minimal activity for at least 6 weeks (control group) or a 5 week training course with the NEUBIE (experimental group), starting with passive electrical stimulation in the first week post-operation, and moving towards more advanced abdominal movements accompanied with stimulation in the subsequent four weeks.

Official Title
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Effect of Neuromuscular Electrical Stimulation on the Post-Operative Abdominoplasty Patient.

Conditions
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Rectus Diastasis

Intervention / Treatment
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* Device: NEUBIE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Rectus Diastasis Previous pregnancy Excess localized adiposity in the lower abdomen Excess atrophic skin of the abdomen Physician clearance to participate Scheduled for full abdominoplasty (no mini-abdominoplasty included) Exclusion Criteria: Currently pregnant Cardiac Pacemaker Active or recent cancer in the abdominal area Active or recent blood clots in the abdominal area History of epilepsy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Study will be divided into two randomly assigned groups - control and interventional. Control group will receive current standard of care for recovery (rest and minimal activity for 6 weeks post-operative). Interventional group will receive neuromuscular electrical stimulation treatments 2 times a week for 6 weeks post-operative.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NEUBIE<br>Experimental group will receive rehabilitation training with the NEUBIE for 6 weeks post-operative. Training will occur at Neufit 2x a week from week 1-5, and will be administered by NeuFit clinic staff. Exercises and ability to complete exercises will be recorded by NeuFit staff in standardized clinic evaluation forms. Participants will undergo will undergo both active muscle tests and body analysis tests. Measurements will be taken at The Piazza Center by clinic staff prior to surgery at 2,4,6,8, and 12 weeks post-operative. Measurements will be used to demonstrate milestones of functional recovery, comparable between subjects by weeks achieved. | Device: NEUBIE<br>* Participants will be asked to undergo electrical stimulation with the NEUBIE at their treatment threshold. Treatment threshold will be described as uncomfortable, but not painful (a 7 out of 10 on a perceived intensity scale). Session length: ≤ 30 minutes Treatment frequency: 2x per week for 5 weeks Week 1 post-op (treatments 1-2) Activity: Passive Neubie on Abdominals & Obliques Weeks 2-3 (treatments 3-6) Passive Neubie Isometric movements with Neubie on abdominals and obliques Active mobilizations with Neubie on abdominals and obliques Weeks 4-5 (treatments 7-10) Active mobilizations with Neubie on abdominals and obliques Core Strength Exercise circuit with Neubie on abdominals and obliques<br>* Other names: NeuFit;|
| No Intervention: Control<br>Control group will receive current post-operative standard of care for abdominoplasty, which includes using an abdominal binder, rest and minimal activity for 6 weeks. Participants will undergo both active muscle tests and body analysis tests. Measurements will be taken at The Piazza Center by clinic staff prior to surgery at 2,4,6,8, and 12 weeks post-operative. Measurements will be used to demonstrate milestones of functional recovery, comparable between subjects by weeks achieved. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bio-impedance analysis muscle mass | Bioelectrical impedance analysis is a method for estimating body composition, in particular body fat and muscle mass, where a weak electric current flows through the body and the voltage is measured in order to calculate impedance (resistance) of the body. Here it will be used to measure muscle mass. | Pre-intervention | 
| Bio-impedance analysis trunk fat | Bioelectrical impedance analysis is a method for estimating body composition, in particular body fat and muscle mass, where a weak electric current flows through the body and the voltage is measured in order to calculate impedance (resistance) of the body. Here it will be used to measure body fat. | Pre-intervention | 
| Bio-impedance analysis trunk mass | Bioelectrical impedance analysis is a method for estimating body composition, in particular body fat and muscle mass, where a weak electric current flows through the body and the voltage is measured in order to calculate impedance (resistance) of the body. Here it will be used to measure trunk mass. | Pre-intervention | 
| Bio-impedance analysis muscle mass | Bioelectrical impedance analysis is a method for estimating body composition, in particular body fat and muscle mass, where a weak electric current flows through the body and the voltage is measured in order to calculate impedance (resistance) of the body. Here it will be used to measure muscle mass. | 2 weeks | 
| Bio-impedance analysis trunk fat | Bioelectrical impedance analysis is a method for estimating body composition, in particular body fat and muscle mass, where a weak electric current flows through the body and the voltage is measured in order to calculate impedance (resistance) of the body. Here it will be used to measure trunk body fat. | 2 weeks | 
| Bio-impedance analysis trunk mass | Bioelectrical impedance analysis is a method for estimating body composition, in particular body fat and muscle mass, where a weak electric current flows through the body and the voltage is measured in order to calculate impedance (resistance) of the body. Here it will be used to measure trunk mass. | 2 weeks | 
| Bio-impedance analysis muscle mass | Bioelectrical impedance analysis is a method for estimating body composition, in particular body fat and muscle mass, where a weak electric current flows through the body and the voltage is measured in order to calculate impedance (resistance) of the body. Here it will be used to measure muscle mass. | 4 weeks | 
| Bio-impedance analysis trunk fat | Bioelectrical impedance analysis is a method for estimating body composition, in particular body fat and muscle mass, where a weak electric current flows through the body and the voltage is measured in order to calculate impedance (resistance) of the body. Here it will be used to measure trunk body fat. | 4 weeks | 
| Bio-impedance analysis trunk mass | Bioelectrical impedance analysis is a method for estimating body composition, in particular body fat and muscle mass, where a weak electric current flows through the body and the voltage is measured in order to calculate impedance (resistance) of the body. Here it will be used to measure trunk mass. | 4 weeks | 
| Bio-impedance analysis muscle mass | Bioelectrical impedance analysis is a method for estimating body composition, in particular body fat and muscle mass, where a weak electric current flows through the body and the voltage is measured in order to calculate impedance (resistance) of the body. Here it will be used to measure muscle mass. | 6 weeks | 
| Bio-impedance analysis trunk fat | Bioelectrical impedance analysis is a method for estimating body composition, in particular body fat and muscle mass, where a weak electric current flows through the body and the voltage is measured in order to calculate impedance (resistance) of the body. Here it will be used to measure trunk body fat. | 6 weeks | 
| Bio-impedance analysis trunk mass | Bioelectrical impedance analysis is a method for estimating body composition, in particular body fat and muscle mass, where a weak electric current flows through the body and the voltage is measured in order to calculate impedance (resistance) of the body. Here it will be used to measure trunk mass. | 6 weeks | 
| Bio-impedance analysis muscle mass | Bioelectrical impedance analysis is a method for estimating body composition, in particular body fat and muscle mass, where a weak electric current flows through the body and the voltage is measured in order to calculate impedance (resistance) of the body. Here it will be used to measure muscle mass. | 8 weeks | 
| Bio-impedance analysis trunk fat | Bioelectrical impedance analysis is a method for estimating body composition, in particular body fat and muscle mass, where a weak electric current flows through the body and the voltage is measured in order to calculate impedance (resistance) of the body. Here it will be used to measure trunk body fat. | 8 weeks | 
| Bio-impedance analysis trunk mass | Bioelectrical impedance analysis is a method for estimating body composition, in particular body fat and muscle mass, where a weak electric current flows through the body and the voltage is measured in order to calculate impedance (resistance) of the body. Here it will be used to measure trunk mass. | 8 weeks | 
| Bio-impedance analysis muscle mass | Bioelectrical impedance analysis is a method for estimating body composition, in particular body fat and muscle mass, where a weak electric current flows through the body and the voltage is measured in order to calculate impedance (resistance) of the body. Here it will be used to measure muscle mass. | 12 weeks | 
| Bio-impedance analysis trunk fat | Bioelectrical impedance analysis is a method for estimating body composition, in particular body fat and muscle mass, where a weak electric current flows through the body and the voltage is measured in order to calculate impedance (resistance) of the body. Here it will be used to measure trunk body fat. | 12 weeks | 
| Bio-impedance analysis muscle mass | Bioelectrical impedance analysis is a method for estimating body composition, in particular body fat and muscle mass, where a weak electric current flows through the body and the voltage is measured in order to calculate impedance (resistance) of the body. Here it will be used to measure trunk mass. | 12 weeks | 
| Range of Motion | Range of motion is determined via a goniometer. Body is moved in specific directions and goniometer is used to measure the amount of motion that occurs. | Pre-intervention | 
| Range of Motion | Range of motion is determined via a goniometer. Body is moved in specific directions and goniometer is used to measure the amount of motion that occurs. | 2 weeks | 
| Range of Motion | Range of motion is determined via a goniometer. Body is moved in specific directions and goniometer is used to measure the amount of motion that occurs. | 4 weeks | 
| Range of Motion | Range of motion is determined via a goniometer. Body is moved in specific directions and goniometer is used to measure the amount of motion that occurs. | 6 weeks | 
| Range of Motion | Range of motion is determined via a goniometer. Body is moved in specific directions and goniometer is used to measure the amount of motion that occurs. | 8 weeks | 
| Range of Motion | Range of motion is determined via a goniometer. Body is moved in specific directions and goniometer is used to measure the amount of motion that occurs. | 12 weeks | 
| Core strength and endurance bridge | Core strength and endurance will be measured by duration of ability to hold a glute bridge. | Pre-intervention | 
| Core strength and endurance plank | Core strength and endurance will be measured by duration of ability to hold a plank. | Pre-intervention | 
| Core strength and endurance bridge | Core strength and endurance will be measured by duration of ability to hold a glute bridge. | 2 weeks | 
| Core strength and endurance plank | Core strength and endurance will be measured by duration of ability to hold a glute bridge. | 2 weeks | 
| Core strength and endurance plank | Core strength and endurance will be measured by duration of ability to hold a plank. | 4 weeks | 
| Core strength and endurance bridge | Core strength and endurance will be measured by duration of ability to hold a glute bridge. | 4 weeks | 
| Core strength and endurance plank | Core strength and endurance will be measured by duration of ability to hold a plank. | 6 weeks | 
| Core strength and endurance bridge | Core strength and endurance will be measured by duration of ability to hold a glute bridge. | 6 weeks | 
| Core strength and endurance plank | Core strength and endurance will be measured by duration of ability to hold a plank. | 8 weeks | 
| Core strength and endurance bridge | Core strength and endurance will be measured by duration of ability to hold a glute bridge. | 8 weeks | 
| Core strength and endurance plank | Core strength and endurance will be measured by duration of ability to hold a plank. | 12 weeks | 
| Core strength and endurance bridge | Core strength and endurance will be measured by duration of ability to hold a glute bridge. | 12 weeks | 
| Lower abdominal strength | Lower abdominal strength will be measured by ability to perform an eccentric double leg lowering movement. | Pre-intervention | 
| Lower abdominal strength | Lower abdominal strength will be measured by ability to perform an eccentric double leg lowering movement. | 2 weeks | 
| Lower abdominal strength | Lower abdominal strength will be measured by ability to perform an eccentric double leg lowering movement. | 4 weeks | 
| Lower abdominal strength | Lower abdominal strength will be measured by ability to perform an eccentric double leg lowering movement. | 6 weeks | 
| Lower abdominal strength | Lower abdominal strength will be measured by ability to perform an eccentric double leg lowering movement. | 8 weeks | 
| Lower abdominal strength | Lower abdominal strength will be measured by ability to perform an eccentric double leg lowering movement. | 12 weeks | 
| Sit up Test | Ability to complete a sit up will be measured as a general measurement of core strength and range of motion. | Pre-intervention | 
| Sit up Test | Ability to complete a sit up will be measured as a general measurement of core strength and range of motion. | 2 weeks | 
| Sit up Test | Ability to complete a sit up will be measured as a general measurement of core strength and range of motion. | 4 weeks | 
| Sit up Test | Ability to complete a sit up will be measured as a general measurement of core strength and range of motion. | 6 weeks | 
| Sit up Test | Ability to complete a sit up will be measured as a general measurement of core strength and range of motion. | 8 weeks | 
| Sit up Test | Ability to complete a sit up will be measured as a general measurement of core strength and range of motion. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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abdominoplasty, NEUBIE, neuromuscular electrical stimulation, rectus diastatis