Clinical trial NCT05229692: Effect of Neuromuscular Electrical Stimulation on the Post-Operative Abdominoplasty Patient.
Official title: Effect of Neuromuscular Electrical Stimulation on the Post-Operative Abdominoplasty Patient.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Rectus Diastasis
Keywords: abdominoplasty
NEUBIE
neuromuscular electrical stimulation
rectus diastatis
Lead sponsor: NeuFit - Neurological Fitness and Education
Sponsor class: INDUSTRY
Collaborators: name: University of Texas at Austin
First posted: 2022-02-08
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Bio-impedance analysis muscle mass
timeFrame: Pre-intervention
measure: Bio-impedance analysis trunk fat
timeFrame: Pre-intervention
measure: Bio-impedance analysis trunk mass
timeFrame: Pre-intervention
measure: Bio-impedance analysis muscle mass
timeFrame: 2 weeks
measure: Bio-impedance analysis trunk fat
timeFrame: 2 weeks
measure: Bio-impedance analysis trunk mass
timeFrame: 2 weeks
measure: Bio-impedance analysis muscle mass
timeFrame: 4 weeks
measure: Bio-impedance analysis trunk fat
timeFrame: 4 weeks
measure: Bio-impedance analysis trunk mass
timeFrame: 4 weeks
measure: Bio-impedance analysis muscle mass
timeFrame: 6 weeks
measure: Bio-impedance analysis trunk fat
timeFrame: 6 weeks
measure: Bio-impedance analysis trunk mass
timeFrame: 6 weeks
measure: Bio-impedance analysis muscle mass
timeFrame: 8 weeks
measure: Bio-impedance analysis trunk fat
timeFrame: 8 weeks
measure: Bio-impedance analysis trunk mass
timeFrame: 8 weeks
measure: Bio-impedance analysis muscle mass
timeFrame: 12 weeks
measure: Bio-impedance analysis trunk fat
timeFrame: 12 weeks
measure: Bio-impedance analysis muscle mass
timeFrame: 12 weeks
measure: Range of Motion
timeFrame: Pre-intervention
measure: Range of Motion
timeFrame: 2 weeks
measure: Range of Motion
timeFrame: 4 weeks
measure: Range of Motion
timeFrame: 6 weeks
measure: Range of Motion
timeFrame: 8 weeks
measure: Range of Motion
timeFrame: 12 weeks
measure: Core strength and endurance bridge
timeFrame: Pre-intervention
measure: Core strength and endurance plank
timeFrame: Pre-intervention
measure: Core strength and endurance bridge
timeFrame: 2 weeks
measure: Core strength and endurance plank
timeFrame: 2 weeks
measure: Core strength and endurance plank
timeFrame: 4 weeks
measure: Core strength and endurance bridge
timeFrame: 4 weeks
measure: Core strength and endurance plank
timeFrame: 6 weeks
measure: Core strength and endurance bridge
timeFrame: 6 weeks
measure: Core strength and endurance plank
timeFrame: 8 weeks
measure: Core strength and endurance bridge
timeFrame: 8 weeks
measure: Core strength and endurance plank
timeFrame: 12 weeks
measure: Core strength and endurance bridge
timeFrame: 12 weeks
measure: Lower abdominal strength
timeFrame: Pre-intervention
measure: Lower abdominal strength
timeFrame: 2 weeks
measure: Lower abdominal strength
timeFrame: 4 weeks
measure: Lower abdominal strength
timeFrame: 6 weeks
measure: Lower abdominal strength
timeFrame: 8 weeks
measure: Lower abdominal strength
timeFrame: 12 weeks
measure: Sit up Test
timeFrame: Pre-intervention
measure: Sit up Test
timeFrame: 2 weeks
measure: Sit up Test
timeFrame: 4 weeks
measure: Sit up Test
timeFrame: 6 weeks
measure: Sit up Test
timeFrame: 8 weeks
measure: Sit up Test
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: Piazza Center for Plastic Surgery and Advanced Skin Care
state: Texas
Study officials:
affiliation: University of Texas - Austin
name: Rocco Piazza, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.