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

NCT05229692 | Withdrawn FDA Device

• 1 other identifier: STUDY00000863
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Rectus Diastasis

Keywords

abdominoplasty; NEUBIE; neuromuscular electrical stimulation; rectus diastatis

Outcome Measures

Primary Outcomes (48)

• 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

Study Arms (2)

NEUBIE

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

NEUBIE DEVICE

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

Also known as: NeuFit

NEUBIE

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Currently pregnant
• Cardiac Pacemaker
• Active or recent cancer in the abdominal area
• Active or recent blood clots in the abdominal area
• History of epilepsy

Sponsors & Collaborators

• NeuFit - Neurological Fitness and Education: lead
• University of Texas at Austin: collaborator

Study Sites (1)

Piazza Center for Plastic Surgery and Advanced Skin Care

Austin, Texas, 78749, United States

Location

Related Publications (8)

• Thakral G, Lafontaine J, Najafi B, Talal TK, Kim P, Lavery LA. Electrical stimulation to accelerate wound healing. Diabet Foot Ankle. 2013 Sep 16;4. doi: 10.3402/dfa.v4i0.22081.

  PMID: 24049559 BACKGROUND

• Ud-Din S, Bayat A. Electrical Stimulation and Cutaneous Wound Healing: A Review of Clinical Evidence. Healthcare (Basel). 2014 Oct 27;2(4):445-67. doi: 10.3390/healthcare2040445.

  PMID: 27429287 BACKGROUND

• da Silva MP, Liebano RE, Rodrigues VA, Abla LE, Ferreira LM. Transcutaneous electrical nerve stimulation for pain relief after liposuction: a randomized controlled trial. Aesthetic Plast Surg. 2015 Apr;39(2):262-9. doi: 10.1007/s00266-015-0451-6. Epub 2015 Feb 10.

  PMID: 25665520 BACKGROUND

• Klika AK, Yakubek G, Piuzzi N, Calabrese G, Barsoum WK, Higuera CA. Neuromuscular Electrical Stimulation Use after Total Knee Arthroplasty Improves Early Return to Function: A Randomized Trial. J Knee Surg. 2022 Jan;35(1):104-111. doi: 10.1055/s-0040-1713420. Epub 2020 Jul 1.

  PMID: 32610358 BACKGROUND

• Delanois R, Sodhi N, Acuna A, Doll K, Mont MA, Bhave A. Use of home neuromuscular electrical stimulation in the first 6 weeks improves function and reduces pain after primary total knee arthroplasty: a matched comparison. Ann Transl Med. 2019 Oct;7(Suppl 7):S254. doi: 10.21037/atm.2019.09.150.

  PMID: 31728378 BACKGROUND

• Demircioglu DT, Paker N, Erbil E, Bugdayci D, Emre TY. The effect of neuromuscular electrical stimulation on functional status and quality of life after knee arthroplasty: a randomized controlled study. J Phys Ther Sci. 2015 Aug;27(8):2501-6. doi: 10.1589/jpts.27.2501. Epub 2015 Aug 21.

  PMID: 26355656 BACKGROUND

• Bistolfi A, Zanovello J, Ferracini R, Allisiardi F, Lioce E, Magistroni E, Berchialla P, Da Rold I, Massazza G. Evaluation of the Effectiveness of Neuromuscular Electrical Stimulation After Total Knee Arthroplasty: A Meta-Analysis. Am J Phys Med Rehabil. 2018 Feb;97(2):123-130. doi: 10.1097/PHM.0000000000000847.

  PMID: 29016401 BACKGROUND

• Yue C, Zhang X, Zhu Y, Jia Y, Wang H, Liu Y. Systematic Review of Three Electrical Stimulation Techniques for Rehabilitation After Total Knee Arthroplasty. J Arthroplasty. 2018 Jul;33(7):2330-2337. doi: 10.1016/j.arth.2018.01.070. Epub 2018 Feb 6.

  PMID: 29530519 BACKGROUND

Study Officials

• Rocco Piazza, MD

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes will be assessed at Piazza Surgical Center. Assessors will be blinded to which intervention participant has received.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 23, 2021
• First Posted: February 8, 2022
• Study Start: June 25, 2022
• Primary Completion: August 1, 2023
• Study Completion: December 1, 2023
• Last Updated: August 9, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)