Rectus DiastasisNCT05229692
Effect of Neuromuscular Electrical Stimulation on the Post-Operative Abdominoplasty Patient.
A study testing NEUBIE in people with Rectus Diastasis, run by NeuFit - Neurological Fitness and Education at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Rectus Diastasis
- What is being tested?
- NEUBIE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2022to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Currently pregnant
- Cardiac Pacemaker
- Active or recent cancer in the abdominal area
- Active or recent blood clots in the abdominal area
- History of epilepsy
Trial locations and contacts
1 site in 1 country.
United States1 site
Piazza Center for Plastic Surgery and Advanced Skin Care
Austin, Texas, 78749
About this study
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).
Read the 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
- Being tested
- NEUBIE
- Keywords
- abdominoplasty, NEUBIE, neuromuscular electrical stimulation, rectus diastatis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEUBIEDevice
Also called NeuFit
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
| Study group | Role | What they receive |
|---|---|---|
| NEUBIE | Experimental | 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. Receives: Device: NEUBIE |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bio-impedance analysis muscle mass
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 muscle mass.
Measured: Pre-intervention
Bio-impedance analysis trunk fat
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 body fat.
Measured: Pre-intervention
Bio-impedance analysis trunk mass
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.
Measured: Pre-intervention
Bio-impedance analysis muscle mass
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 muscle mass.
Measured: 2 weeks
Bio-impedance analysis trunk fat
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.
Measured: 2 weeks
Bio-impedance analysis trunk mass
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.
Measured: 2 weeks
Bio-impedance analysis muscle mass
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 muscle mass.
Measured: 4 weeks
Bio-impedance analysis trunk fat
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.
Measured: 4 weeks
Bio-impedance analysis trunk mass
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.
Measured: 4 weeks
Bio-impedance analysis muscle mass
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 muscle mass.
Measured: 6 weeks
Bio-impedance analysis trunk fat
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.
Measured: 6 weeks
Bio-impedance analysis trunk mass
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.
Measured: 6 weeks
Bio-impedance analysis muscle mass
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 muscle mass.
Measured: 8 weeks
Bio-impedance analysis trunk fat
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.
Measured: 8 weeks
Bio-impedance analysis trunk mass
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.
Measured: 8 weeks
Bio-impedance analysis muscle mass
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 muscle mass.
Measured: 12 weeks
Bio-impedance analysis trunk fat
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.
Measured: 12 weeks
Bio-impedance analysis muscle mass
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.
Measured: 12 weeks
Range of Motion
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.
Measured: Pre-intervention
Range of Motion
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.
Measured: 2 weeks
Range of Motion
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.
Measured: 4 weeks
Range of Motion
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.
Measured: 6 weeks
Range of Motion
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.
Measured: 8 weeks
Range of Motion
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.
Measured: 12 weeks
Core strength and endurance bridge
Core strength and endurance will be measured by duration of ability to hold a glute bridge.
Measured: Pre-intervention
Core strength and endurance plank
Core strength and endurance will be measured by duration of ability to hold a plank.
Measured: Pre-intervention
Core strength and endurance bridge
Core strength and endurance will be measured by duration of ability to hold a glute bridge.
Measured: 2 weeks
Core strength and endurance plank
Core strength and endurance will be measured by duration of ability to hold a glute bridge.
Measured: 2 weeks
Core strength and endurance plank
Core strength and endurance will be measured by duration of ability to hold a plank.
Measured: 4 weeks
Core strength and endurance bridge
Core strength and endurance will be measured by duration of ability to hold a glute bridge.
Measured: 4 weeks
Core strength and endurance plank
Core strength and endurance will be measured by duration of ability to hold a plank.
Measured: 6 weeks
Core strength and endurance bridge
Core strength and endurance will be measured by duration of ability to hold a glute bridge.
Measured: 6 weeks
Core strength and endurance plank
Core strength and endurance will be measured by duration of ability to hold a plank.
Measured: 8 weeks
Core strength and endurance bridge
Core strength and endurance will be measured by duration of ability to hold a glute bridge.
Measured: 8 weeks
Core strength and endurance plank
Core strength and endurance will be measured by duration of ability to hold a plank.
Measured: 12 weeks
Core strength and endurance bridge
Core strength and endurance will be measured by duration of ability to hold a glute bridge.
Measured: 12 weeks
Lower abdominal strength
Lower abdominal strength will be measured by ability to perform an eccentric double leg lowering movement.
Measured: Pre-intervention
Lower abdominal strength
Lower abdominal strength will be measured by ability to perform an eccentric double leg lowering movement.
Measured: 2 weeks
Lower abdominal strength
Lower abdominal strength will be measured by ability to perform an eccentric double leg lowering movement.
Measured: 4 weeks
Lower abdominal strength
Lower abdominal strength will be measured by ability to perform an eccentric double leg lowering movement.
Measured: 6 weeks
Lower abdominal strength
Lower abdominal strength will be measured by ability to perform an eccentric double leg lowering movement.
Measured: 8 weeks
Lower abdominal strength
Lower abdominal strength will be measured by ability to perform an eccentric double leg lowering movement.
Measured: 12 weeks
Sit up Test
Ability to complete a sit up will be measured as a general measurement of core strength and range of motion.
Measured: Pre-intervention
Sit up Test
Ability to complete a sit up will be measured as a general measurement of core strength and range of motion.
Measured: 2 weeks
Sit up Test
Ability to complete a sit up will be measured as a general measurement of core strength and range of motion.
Measured: 4 weeks
Sit up Test
Ability to complete a sit up will be measured as a general measurement of core strength and range of motion.
Measured: 6 weeks
Sit up Test
Ability to complete a sit up will be measured as a general measurement of core strength and range of motion.
Measured: 8 weeks
Sit up Test
Ability to complete a sit up will be measured as a general measurement of core strength and range of motion.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start25 Jun 2022
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Why it stopped: Lack of interest from participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Rectus DiastasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeuFit - Neurological Fitness and Education
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Texas at Austin
- Responsible party
- Sponsor
- Investigators
- Rocco Piazza, MD, Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05229692
- Sponsor's protocol ID
- STUDY00000863
- Status last verified
- Aug 2023
- First submitted
- 23 Aug 2021
- Last updated
- 9 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Thakral G, Lafontaine J, Najafi B, Talal TK, Kim P, Lavery LA. Electrical stimulation to accelerate wound healing. Diabet Foot Ankle. 2013 Sep 16;4. doi: 10.3402/dfa.v4i0.22081.
PubMed 24049559Ud-Din S, Bayat A. Electrical Stimulation and Cutaneous Wound Healing: A Review of Clinical Evidence. Healthcare (Basel). 2014 Oct 27;2(4):445-67. doi: 10.3390/healthcare2040445.
PubMed 27429287da Silva MP, Liebano RE, Rodrigues VA, Abla LE, Ferreira LM. Transcutaneous electrical nerve stimulation for pain relief after liposuction: a randomized controlled trial. Aesthetic Plast Surg. 2015 Apr;39(2):262-9. doi: 10.1007/s00266-015-0451-6. Epub 2015 Feb 10.
PubMed 25665520Klika AK, Yakubek G, Piuzzi N, Calabrese G, Barsoum WK, Higuera CA. Neuromuscular Electrical Stimulation Use after Total Knee Arthroplasty Improves Early Return to Function: A Randomized Trial. J Knee Surg. 2022 Jan;35(1):104-111. doi: 10.1055/s-0040-1713420. Epub 2020 Jul 1.
PubMed 32610358Delanois R, Sodhi N, Acuna A, Doll K, Mont MA, Bhave A. Use of home neuromuscular electrical stimulation in the first 6 weeks improves function and reduces pain after primary total knee arthroplasty: a matched comparison. Ann Transl Med. 2019 Oct;7(Suppl 7):S254. doi: 10.21037/atm.2019.09.150.
PubMed 31728378Demircioglu 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.
PubMed 26355656Bistolfi 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.
PubMed 29016401Yue 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.
PubMed 29530519
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Neuromuscular Electrical Stimulation on the Post-Operative Abdominoplasty Patient.
- ClinicalTrials.gov ID
- NCT05229692
- Acronym / sponsor ID
- STUDY00000863
- Conditions
- Rectus Diastasis
- Keywords
- abdominoplasty, NEUBIE, neuromuscular electrical stimulation, rectus diastatis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of interest from participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NeuFit - Neurological Fitness and EducationIndustry (pharma, biotech, devices)
- Collaborators
- University of Texas at Austin
- Study start
- 25 Jun 2022 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 8 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| NEUBIE | Experimental | Device: NEUBIEExperimental 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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Rectus Diastasis
- Previous pregnancy
- Excess localized adiposity in the lower abdomen
- Excess atrophic skin of the abdomen
- Physician clearance to participate
Key exclusion criteria (5 listed)
- Currently pregnant
- Cardiac Pacemaker
- Active or recent cancer in the abdominal area
- Active or recent blood clots in the abdominal area
- History of epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NEUBIEAlso: NeuFitParticipants 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 | Device | NEUBIE |
Primary outcome
Bio-impedance analysis muscle mass
Time frame: Pre-intervention
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 muscle mass.
Bio-impedance analysis trunk fat
Time frame: Pre-intervention
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 body fat.
Bio-impedance analysis trunk mass
Time frame: Pre-intervention
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.
Bio-impedance analysis muscle mass
Time frame: 2 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 muscle mass.
Bio-impedance analysis trunk fat
Time frame: 2 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: 2 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.
Bio-impedance analysis muscle mass
Time frame: 4 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 muscle mass.
Bio-impedance analysis trunk fat
Time frame: 4 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: 4 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.
Bio-impedance analysis muscle mass
Time frame: 6 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 muscle mass.
Bio-impedance analysis trunk fat
Time frame: 6 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: 6 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.
Bio-impedance analysis muscle 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 muscle mass.
Bio-impedance analysis trunk fat
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 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.
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 muscle mass.
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 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.
Range of Motion
Time frame: Pre-intervention
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.
Range of Motion
Time frame: 2 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.
Range of Motion
Time frame: 4 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.
Range of Motion
Time frame: 6 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.
Range of Motion
Time frame: 8 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.
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 bridge
Time frame: Pre-intervention
Core strength and endurance will be measured by duration of ability to hold a glute bridge.
Core strength and endurance plank
Time frame: Pre-intervention
Core strength and endurance will be measured by duration of ability to hold a plank.
Core strength and endurance bridge
Time frame: 2 weeks
Core strength and endurance will be measured by duration of ability to hold a glute bridge.
Core strength and endurance plank
Time frame: 2 weeks
Core strength and endurance will be measured by duration of ability to hold a glute bridge.
Core strength and endurance plank
Time frame: 4 weeks
Core strength and endurance will be measured by duration of ability to hold a plank.
Core strength and endurance bridge
Time frame: 4 weeks
Core strength and endurance will be measured by duration of ability to hold a glute bridge.
Core strength and endurance plank
Time frame: 6 weeks
Core strength and endurance will be measured by duration of ability to hold a plank.
Core strength and endurance bridge
Time frame: 6 weeks
Core strength and endurance will be measured by duration of ability to hold a glute bridge.
Core strength and endurance plank
Time frame: 8 weeks
Core strength and endurance will be measured by duration of ability to hold a plank.
Core strength and endurance bridge
Time frame: 8 weeks
Core strength and endurance will be measured by duration of ability to hold a glute bridge.
Core strength and endurance plank
Time frame: 12 weeks
Core strength and endurance will be measured by duration of ability to hold a plank.
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.
Lower abdominal strength
Time frame: Pre-intervention
Lower abdominal strength will be measured by ability to perform an eccentric double leg lowering movement.
Lower abdominal strength
Time frame: 2 weeks
Lower abdominal strength will be measured by ability to perform an eccentric double leg lowering movement.
Lower abdominal strength
Time frame: 4 weeks
Lower abdominal strength will be measured by ability to perform an eccentric double leg lowering movement.
Lower abdominal strength
Time frame: 6 weeks
Lower abdominal strength will be measured by ability to perform an eccentric double leg lowering movement.
Lower abdominal strength
Time frame: 8 weeks
Lower abdominal strength will be measured by ability to perform an eccentric double leg lowering movement.
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: Pre-intervention
Ability to complete a sit up will be measured as a general measurement of core strength and range of motion.
Sit up Test
Time frame: 2 weeks
Ability to complete a sit up will be measured as a general measurement of core strength and range of motion.
Sit up Test
Time frame: 4 weeks
Ability to complete a sit up will be measured as a general measurement of core strength and range of motion.
Sit up Test
Time frame: 6 weeks
Ability to complete a sit up will be measured as a general measurement of core strength and range of motion.
Sit up Test
Time frame: 8 weeks
Ability to complete a sit up will be measured as a general measurement of core strength and range of motion.
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
- Background: PubMed 24049559Thakral G, Lafontaine J, Najafi B, Talal TK, Kim P, Lavery LA. Electrical stimulation to accelerate wound healing. Diabet Foot Ankle. 2013 Sep 16;4. doi: 10.3402/dfa.v4i0.22081.
- Background: PubMed 27429287Ud-Din S, Bayat A. Electrical Stimulation and Cutaneous Wound Healing: A Review of Clinical Evidence. Healthcare (Basel). 2014 Oct 27;2(4):445-67. doi: 10.3390/healthcare2040445.
- Background: PubMed 25665520da Silva MP, Liebano RE, Rodrigues VA, Abla LE, Ferreira LM. Transcutaneous electrical nerve stimulation for pain relief after liposuction: a randomized controlled trial. Aesthetic Plast Surg. 2015 Apr;39(2):262-9. doi: 10.1007/s00266-015-0451-6. Epub 2015 Feb 10.
- Background: PubMed 32610358Klika AK, Yakubek G, Piuzzi N, Calabrese G, Barsoum WK, Higuera CA. Neuromuscular Electrical Stimulation Use after Total Knee Arthroplasty Improves Early Return to Function: A Randomized Trial. J Knee Surg. 2022 Jan;35(1):104-111. doi: 10.1055/s-0040-1713420. Epub 2020 Jul 1.
- Background: PubMed 31728378Delanois R, Sodhi N, Acuna A, Doll K, Mont MA, Bhave A. Use of home neuromuscular electrical stimulation in the first 6 weeks improves function and reduces pain after primary total knee arthroplasty: a matched comparison. Ann Transl Med. 2019 Oct;7(Suppl 7):S254. doi: 10.21037/atm.2019.09.150.
- Background: PubMed 26355656Demircioglu 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.
- Background: PubMed 29016401Bistolfi 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.
- Background: PubMed 29530519Yue 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rocco Piazza, MD principal investigator
University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NEUBIE in people with Rectus Diastasis, run by NeuFit - Neurological Fitness and Education at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bio-impedance analysis muscle mass (time frame: Pre-intervention). The study lists 48 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05229692, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2023.