EMS device
DeviceEMS treatment will be performed
NCT Number: NCT03917160
The objective of the study is to evaluate the safety and efficacy of Abdominal EMS (Electrical Muscle Stimulation) on AWR (Abdominal Wall Restoration) in Post - Partum Women
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Notify Me18 year–45 year
Female
Interventional
Not applicable
Southern Oklahoma Women's Health, Ardmore, Oklahoma, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
EMS treatment will be performed
Time frame: 1 month
Up to 5 subjects will undergo MRI to evaluate effect of the treatment
Time frame: 1 Month, 3 Months, 6 Months
Time frame: 1 Month, 3 Months, 6 Months
Pelvic Floor Distress Inventory - The PFDI-20 is both a symptom inventory and a measure of the degree of bother and distress (quality-of-life) caused by pelvic floor symptoms.
Time frame: 1 Month, 3 Months, 6 Months
Pain will be assessed based on the Numerical Scale Response (NSR).
Time frame: 1 Month, 3 Months, 6 Months
Satisfaction assessment will be performed by the study investigator using using 0 - 4 -points Likert scale
Time frame: 1 Month, 3 Months, 6 Months
Improvement and satisfaction assessment will be performed independently by the subject using 0 - 4 -points Likert scale
InMode MD Ltd.
Industry
A Randomized Controlled Trial to Evaluate the Effect of Abdominal EMS (Electrical Muscle Stimulation) on AWR (Abdominal Wall Restoration) in Post - Partum Women
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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