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

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05229692
Enrollment
0
Registered
2022-02-08
Start date
2022-06-25
Completion date
2023-12-01
Last updated
2023-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectus Diastasis

Keywords

abdominoplasty, NEUBIE, neuromuscular electrical stimulation, rectus diastatis

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).

Detailed description

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.

Interventions

DEVICENEUBIE

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

Sponsors

University of Texas at Austin
CollaboratorOTHER
NeuFit - Neurological Fitness and Education
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Outcomes will be assessed at Piazza Surgical Center. Assessors will be blinded to which intervention participant has received.

Intervention 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.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

1. Rectus Diastasis 2. Previous pregnancy 3. Excess localized adiposity in the lower abdomen 4. Excess atrophic skin of the abdomen 5. Physician clearance to participate 6. Scheduled for full abdominoplasty (no mini-abdominoplasty included)

Exclusion criteria

1. Currently pregnant 2. Cardiac Pacemaker 3. Active or recent cancer in the abdominal area 4. Active or recent blood clots in the abdominal area 5. History of epilepsy

Design outcomes

Primary

MeasureTime frameDescription
Bio-impedance analysis muscle massPre-interventionBioelectrical 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.
Bio-impedance analysis trunk fatPre-interventionBioelectrical 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.
Bio-impedance analysis trunk massPre-interventionBioelectrical 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.
Range of MotionPre-interventionRange 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.
Core strength and endurance bridgePre-interventionCore strength and endurance will be measured by duration of ability to hold a glute bridge.
Core strength and endurance plankPre-interventionCore strength and endurance will be measured by duration of ability to hold a plank.
Lower abdominal strengthPre-interventionLower abdominal strength will be measured by ability to perform an eccentric double leg lowering movement.
Sit up TestPre-interventionAbility to complete a sit up will be measured as a general measurement of core strength and range of motion.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026