- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06715059
Tele-rehabilitation in Women With Diastasis Recti Abdominis
Effects of Tele-rehabilitation on Inter-Recti Distance, Postural Balance, Abdominal Endurance and Pelvic Floor Functions
The aim of this randomized controlled study is to determine the effect of motor-control based telerehabilitation exercise program on inter-recti distance, abdominal endurance, pelvic floor dysfunction, and body-image perception in women with diastasis recti abdominis.
Researchers will compare the effects of motor-control-based telerehabilitation exercise program and conventional exercise programs in women with DRA.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
KAgıthane
-
Istanbul, KAgıthane, Turkey
- Istanbul Atlas University
-
-
Kağıthane
-
İstanbul, Kağıthane, Turkey, 34413
- Atlas University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Post- partum women (min 1 - max 5 years)
Exclusion Criteria:
- Having a neurological, orthopedical or any other condition which affect postural stability.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Tele-rehab group
The participants who performed exercise program via online platform.
|
A progressive core stability exercise program will be performed based on motor control principles via an online platform.
|
|
Experimental: Home-based group
The participants who performed exercise program in the home.
|
A core stability exercise program will be performed at home.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Inter-recti distance
Time Frame: baseline
|
The subjects are assessed the inter-recti distance (IRD) in the supine position, knees bent and feet resting position on the table, the subjects is going to be asked to elevate the head and shoulders upwards until the inferior angles of the scapulae were just off the table.The subjects palpated the medial edges of RA muscles and IRD was measured using finger palpation in previously marked five-point: on the umbilicus, 5 cm, and 2 cm above and below the umbilicus
|
baseline
|
|
Inter-recti distance
Time Frame: after 8 weeks
|
The subjects are assessed the inter-recti distance (IRD) in the supine position, knees bent and feet resting position on the table, the subjects is going to be asked to elevate the head and shoulders upwards until the inferior angles of the scapulae were just off the table.The subjects palpated the medial edges of RA muscles and IRD was measured using finger palpation in previously marked five-point: on the umbilicus, 5 cm, and 2 cm above and below the umbilicus
|
after 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Abdominal muscle endurance test
Time Frame: baseline
|
The static abdominal flexion endurance test is also performed once in the same position as the IRD test.
The subjects are asked to raise their head and shoulders upwards until the scapulae cleared the table and keep the position as long as possible.
The time was recorded as the score of the test.
|
baseline
|
|
Abdominal muscle endurance test
Time Frame: After 8 weeks
|
The static abdominal flexion endurance test is also performed once in the same position as the IRD test.
The subjects are asked to raise their head and shoulders upwards until the scapulae cleared the table and keep the position as long as possible.
The time was recorded as the score of the test.
|
After 8 weeks
|
|
Pelvic floor dysfunction
Time Frame: baseline
|
Every subject will complete the Turkish version of the short-form of Pelvic Floor Distress Inventory (PFDI-20) which consists of three subscales: the Pelvic Organ Prolapse Distress Inventory short-form (POPDI6), the Urogenital Distress Inventory short-form (UDI-6), and the Colorectal-Anal Distress Inventory short-form (CRADI-8) to assess prolapse and pelvic pressure, urinary symptoms, and bowel symptoms, respectively
|
baseline
|
|
Pelvic floor dysfunction
Time Frame: After 8 weeks
|
Every subject will complete the Turkish version of the short-form of Pelvic Floor Distress Inventory (PFDI-20) which consists of three subscales: the Pelvic Organ Prolapse Distress Inventory short-form (POPDI6), the Urogenital Distress Inventory short-form (UDI-6), and the Colorectal-Anal Distress Inventory short-form (CRADI-8) to assess prolapse and pelvic pressure, urinary symptoms, and bowel symptoms, respectively
|
After 8 weeks
|
|
Body-self relation
Time Frame: baseline
|
Every subject will complete the Turkish version of Multi-Dimensional Body-Self Relations Questionnaire.
|
baseline
|
|
Body-self relation
Time Frame: After 8 weeks
|
Every subject will complete the Turkish version of Multi-Dimensional Body-Self Relations Questionnaire.
|
After 8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hilal DENİZOĞLU KÜLLİ, İSTANBUL ATLAS ÜNİVERSİTESİ
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- hdenizkulli
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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