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

NeuFit

Status: Withdrawn

Conditions: Rectus Diastasis

Treatments: Device: NEUBIE

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05229692

STUDY00000863

Details and patient eligibility

About

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).

Full 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.

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

NEUBIE

Experimental group

Description:

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.

Treatment:

Device: NEUBIE

Control

No Intervention group

Description:

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.