NCT05229692

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: NeuFit - Neurological Fitness and Education · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Rectus Diastasis

Interventions

Type	Name	Description
DEVICE	NEUBIE	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

Timeline

• Start date: 2022-06-25
• Primary completion: 2023-08-01
• Completion: 2023-12-01
• First posted: 2022-02-08
• Last updated: 2023-08-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study