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Clinical Trials/NCT05229692
NCT05229692
Withdrawn
Not Applicable

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

NeuFit - Neurological Fitness and Education1 site in 1 countryJune 25, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Rectus Diastasis
Sponsor
NeuFit - Neurological Fitness and Education
Locations
1
Primary Endpoint
Bio-impedance analysis muscle mass
Status
Withdrawn
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 25, 2022
End Date
December 1, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
NeuFit - Neurological Fitness and Education
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Bio-impedance analysis muscle mass

Time Frame: 12 weeks

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.

Core strength and endurance bridge

Time Frame: 12 weeks

Core strength and endurance will be measured by duration of ability to hold a glute bridge.

Bio-impedance analysis trunk fat

Time Frame: 12 weeks

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.

Bio-impedance analysis trunk mass

Time Frame: 8 weeks

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.

Range of Motion

Time Frame: 12 weeks

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.

Core strength and endurance plank

Time Frame: 12 weeks

Core strength and endurance will be measured by duration of ability to hold a plank.

Lower abdominal strength

Time Frame: 12 weeks

Lower abdominal strength will be measured by ability to perform an eccentric double leg lowering movement.

Sit up Test

Time Frame: 12 weeks

Ability to complete a sit up will be measured as a general measurement of core strength and range of motion.

Study Sites (1)

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