Diastasis RectiNCT06723353
Effects of Visceral Manipulation Combined with Kinesio Taping on Diastasis Recti, Pain Intensity, Stress Incontinence, Pelvic Floor Strength, and Overall Wellness in Postpartum Women
A study testing Visceral Manipulation Therapy, Abdominal Kinesio Taping and Combined Visceral Manipulation and Kinesio Taping in people with Diastasis Recti and Diastasis Recti Abdominis (DRA), run by Health and Research-Insights at 1 site in Pakistan.
Trial summary
This clinical trial aims to evaluate the effectiveness of different therapies for treating Diastasis Recti Abdominis (DRA) in postpartum women. DRA, commonly experienced after childbirth, involves the separation of abdominal muscles, which can lead to discomfort and decreased core stability. Read more about this study
- Who is it for?
- Ages 35 to 45 years, women only
- Conditions the study is for
- Diastasis Recti, Diastasis Recti Abdominis (DRA)
- What is being tested?
- Visceral Manipulation Therapy, Abdominal Kinesio Taping and Combined Visceral Manipulation and Kinesio Taping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2024to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Post-partum female will be included on the basis of:
- DRA: Finger width palpation shows >2.5 cm
- Postpartum females bearing at least 1 child
- Age between 35 to 45 years old
- Post-partum females who had gone through normal vaginal delivery, vacuum delivery, forceps delivery, and lower section caesarian section (at least 1 month after)
Who cannot join
- Postpartum female will be excluded if she has:
- Any other abdominal surgery
- Sensitivity with taping (specific for those will have KT)
- Diagnosed with abdominal hernia
- Open abdominal wound
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Jinnah Postgraduate Medical Center
Karachi, Sindh, 75510
Hafiz Sheraz Arshad, 03004009429
Nasreen Fatima, FCPS, +922199201300, drduakhan@yahoo.com
About this study
This clinical trial aims to evaluate the effectiveness of different therapies for treating Diastasis Recti Abdominis (DRA) in postpartum women. DRA, commonly experienced after childbirth, involves the separation of abdominal muscles, which can lead to discomfort and decreased core stability. The main questions this study seeks to answer are:
How effective are Visceral Manipulation (VM), Kinesio Taping (KT), and core strengthening exercises in reducing the gap between abdominal muscles (Inter-Recti Distance or IRD)? Do these treatments improve pain levels, pelvic floor muscle strength, and urinary incontinence? This study will compare the effects of VM, KT, a combination of both, and core strengthening exercises to determine which therapy-or combination of therapies-most effectively treats DRA.
Read more
Participants will:
Be randomly assigned to one of four treatment groups: VM, KT, VM combined with KT, or core strengthening exercises.
Undergo their designated treatments for a period of 6 weeks. Visit the clinic for assessments at the start, mid-point, and end of the treatment period.
Complete surveys and undergo physical tests to measure changes in IRD, pain levels, pelvic floor strength, and urinary function.
This research will provide valuable insights into the most effective treatments for DRA, aiming to enhance the well-being and recovery of postpartum women.
Read the detailed description
Overview
This clinical trial is designed to investigate the efficacy of various interventions in treating Diastasis Recti Abdominis (DRA) among postpartum women. DRA is a condition characterized by the separation of the left and right sides of the rectus abdominis muscle, commonly occurring during and after pregnancy. This separation can lead to functional impairments such as lower back pain, pelvic floor dysfunctions, and a decrease in core stability, which significantly affects a woman's quality of life.
Purpose
The study aims to assess and compare the effectiveness of four different treatment modalities: Visceral Manipulation (VM), Kinesio Taping (KT), a combination of both VM and KT, and core strengthening exercises. The primary goal is to determine which treatment(s) most effectively reduce the inter-recti distance (IRD), thus alleviating the physical and functional symptoms associated with DRA. Secondary objectives include evaluating the impact of these treatments on associated pain levels, pelvic floor muscle strength, and urinary incontinence, which are common concerns among affected postpartum women.
Study Design
This randomized controlled trial will enroll participants from four major maternity hospitals across Karachi, Pakistan, ensuring a diverse participant pool. Upon meeting inclusion criteria, participants will be randomly assigned to one of the four intervention groups. Each group will receive a specific treatment protocol for six weeks, with assessments scheduled at baseline, the three-week midpoint, and upon completion at six weeks.
Group A: Participants will receive Kinesio Taping applied with approximately 70% tension in a crisscross pattern over the rectus abdominis muscle.
Group B: Participants will undergo Visceral Manipulation, focusing on enhancing the mobility and function of abdominal and pelvic organs.
Group C: This group will receive both VM and KT as combined therapies to maximize the therapeutic benefits.
Group D: Participants in this group will perform targeted core strengthening exercises designed to enhance muscle function and support abdominal healing.
Methodology
Treatment efficacy will be evaluated through a series of quantitative and qualitative measurements:
Inter-Recti Distance (IRD): Measured using the finger-width palpation method, this metric will directly assess the physical gap between the rectus abdominis muscles.
Pain Level: Assessed using the Visual Analogue Scale (VAS), allowing participants to report the intensity of their pain.
Pelvic Floor Muscle Strength: Evaluated using pressure biofeedback units, providing objective data on muscle functionality.
Urinary Incontinence: Measured via the Urinary Distress Inventory-6 (UDI-6), which quantifies symptoms of urinary incontinence.
Data Analysis
Data will be processed and analyzed using the Statistical Package for the Social Sciences (SPSS), version 21.0. Analysis of Covariance (ANCOVA) will be used to compare treatment effects across the groups, adjusting for potential confounders like age and BMI. Repeated measures ANOVA will be employed to evaluate changes within each group over time.
Ethical Considerations
The study has been reviewed and approved by an Institutional Review Board, ensuring that all procedures adhere to ethical guidelines. Participants will provide informed consent before participating, with a guarantee of confidentiality and the right to withdraw from the study at any time without penalty.
Significance
By rigorously evaluating these interventions, the study aims to provide clear, evidence-based guidance on the most effective treatment strategies for managing DRA in postpartum women. This research is crucial not only for enhancing individual patient care but also for informing clinical practices and potentially influencing public health policies related to maternal health and recovery.
- Conditions
- Diastasis Recti, Diastasis Recti Abdominis (DRA)
- Being tested
- Visceral Manipulation Therapy, Abdominal Kinesio Taping, Combined Visceral Manipulation and Kinesio Taping, Postpartum Core Strengthening Program
- Keywords
- Diastasis Recti Abdominis (DRA), Postpartum Recovery, Visceral Manipulation (VM), Kinesio Taping (KT), Core Strengthening Exercises, Pelvic Floor Dysfunction, Inter-Recti Distance (IRD), Urinary Incontinence, Pain Management, Physical Therapy for Postpartum Women
- Medical subject headings
- Urinary Incontinence, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visceral Manipulation TherapyOther
Visceral Manipulation (VM) is a manual therapy consisting of gentle, specifically placed manipulations that encourage normal mobility, tone, and inherent tissue motion of the viscera and their connective tissues. These manipulations can potentially improve the structural integrity of the abdominal cavity and enhance the physiological functioning of the organs. VM will be administered by certified therapists trained in this specialized technique, focusing on reducing the Inter-Recti Distance (IRD) and associated symptoms of DRA.
Abdominal Kinesio TapingOther
Kinesio Taping (KT) involves the application of a thin, stretchable tape over and around muscles to enhance function, reduce inflammation, and support muscles in movement on a 24hr/day basis. It is non-restrictive, allowing for full range of motion. In this study, KT will be applied in a crisscross pattern across the abdomen to support the abdominal muscles affected by DRA, potentially aiding in muscle function and reducing pain and discomfort.
Combined Visceral Manipulation and Kinesio TapingOther
This intervention combines Visceral Manipulation and Kinesio Taping to leverage the benefits of both modalities. The combination aims to enhance the functional and structural support of the abdominal region by improving organ function through VM and providing muscular support through KT. This dual approach is hypothesized to offer a synergistic benefit, potentially providing a more effective treatment for reducing IRD and improving overall abdominal function.
Postpartum Core Strengthening ProgramOther
The Core Strengthening Program is designed to strengthen the deep core muscles, including the transverse abdominis, multifidus, and the pelvic floor muscles. Exercises will be tailored to accommodate postpartum women and will be progressively adjusted to match improvements in strength and endurance. The program includes supervised training sessions focusing on enhancing core stability, which is crucial for postpartum recovery and long-term spinal and pelvic health.
| Study group | Role | What they receive |
|---|---|---|
| Visceral Manipulation | Experimental | Participants in this arm will receive Visceral Manipulation (VM) therapy administered by a trained physical therapist. VM is a gentle manual therapy aimed at releasing restrictions within the visceral system to improve the mobility and function of the internal organs. The therapy sessions will focus on enhancing abdominal organ mobility and will be performed in a clinical setting. This treatment will be administered over a six-week period with sessions occurring once per week. Receives: Other: Visceral Manipulation Therapy |
| Kinesio Taping | Experimental | This arm involves the application of Kinesio Tape (KT) to the abdominal area to support and stabilize the muscles affected by Diastasis Recti Abdominis. The KT will be applied in a crisscross manner to potentially facilitate muscle function and reduce the Inter-Recti Distance (IRD). Participants will receive taping once a week for six weeks, and the tape will be maintained throughout the week to ensure continuous support. Receives: Other: Abdominal Kinesio Taping |
| Combined Visceral Manipulation and Kinesio Taping | Experimental | Participants in this arm will receive a combination of Visceral Manipulation and Kinesio Taping. The combination is intended to maximize the therapeutic effects by enhancing organ function with VM and providing muscular support with KT. The treatments will be administered concurrently during the same six-week period, with weekly sessions for both therapies. Receives: Other: Combined Visceral Manipulation and Kinesio Taping |
| Core Strengthening Exercises | Active comparator | This arm involves participants engaging in core strengthening exercises specifically designed for postpartum rehabilitation. The exercises aim to strengthen the transverse abdominis, multifidus, and pelvic floor muscles, which support the abdominal organs and improve core stability. Participants will perform these exercises under the supervision of a physical therapist three times a week for six weeks to ensure proper technique and progression. Receives: Other: Postpartum Core Strengthening Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Inter-Recti Distance (IRD)
This measure assesses the effectiveness of the interventions in reducing the Inter-Recti Distance (IRD) between the rectus abdominis muscles. The IRD will be measured using the finger-width palpation method, which involves placing fingers horizontally across the midline of the participant's abdomen at, above, and below the umbilicus. This method provides a direct and tangible measure of the gap between the rectus abdominis muscles, which is a primary physical manifestation of Diastasis Recti Abdominis (DRA).
Measured: Baseline, at the end of 3 weeks (mid-intervention), and at the end of 6 weeks (post-intervention)
Secondary outcomes (1)
Improvement in Pelvic Floor Muscle Strength
This secondary outcome measure evaluates the effectiveness of the interventions in enhancing the strength and functionality of pelvic floor muscles. Strength will be quantified using pressure biofeedback units, which provide precise measurements of muscle contraction and relaxation. This assessment is crucial for understanding the broader impact of the interventions on postpartum pelvic health, which is often compromised in cases of DRA.
Measured: Baseline, at the end of 3 weeks (mid-intervention), and at the end of 6 weeks (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start1 May 2024
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diastasis RectiStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Health and Research-Insights
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06723353
- Sponsor's protocol ID
- LUC/CPGS/PHDE/PTR/20240329/001
- Status last verified
- Dec 2024
- First submitted
- 4 Dec 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data (IPD) from this study will not be shared publicly due to concerns over privacy and confidentiality, particularly given the sensitive nature of the health data involved. This decision aligns with the participant consent terms, which specified that data would be used solely for this research. Ethical considerations also dictate maintaining control over the data to ensure integrity and prevent potential misuse. Additionally, logistical limitations regarding the infrastructure necessary for secure data management preclude public sharing. This approach ensures compliance with ethical standards and protects participant trust and data security.
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Visceral Manipulation Combined with Kinesio Taping on Diastasis Recti, Pain Intensity, Stress Incontinence, Pelvic Floor Strength, and Overall Wellness in Postpartum Women
- ClinicalTrials.gov ID
- NCT06723353
- Acronym / sponsor ID
- LUC/CPGS/PHDE/PTR/20240329/001
- Conditions
- Diastasis Recti, Diastasis Recti Abdominis (DRA)
- Keywords
- Diastasis Recti Abdominis (DRA), Postpartum Recovery, Visceral Manipulation (VM), Kinesio Taping (KT), Core Strengthening Exercises, Pelvic Floor Dysfunction, Inter-Recti Distance (IRD), Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Health and Research-InsightsUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 9 Dec 2024 (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.
This clinical trial aims to evaluate the effectiveness of different therapies for treating Diastasis Recti Abdominis (DRA) in postpartum women. DRA, commonly experienced after childbirth, involves the separation of abdominal muscles, which can lead to discomfort and decreased core stability. The main questions this study seeks to answer are:
How effective are Visceral Manipulation (VM), Kinesio Taping (KT), and core strengthening exercises in reducing the gap between abdominal muscles (Inter-Recti Distance or IRD)? Do these treatments improve pain levels, pelvic floor muscle strength, and urinary incontinence? This study will compare the effects of VM, KT, a combination of both, and core strengthening exercises to determine which therapy-or combination of therapies-most effectively treats DRA.
Participants will:
Be randomly assigned to one of four treatment groups: VM, KT, VM combined with KT, or core strengthening exercises.
Undergo their designated treatments for a period of 6 weeks. Visit the clinic for assessments at the start, mid-point, and end of the treatment period.
Complete surveys and undergo physical tests to measure changes in IRD, pain levels, pelvic floor strength, and urinary function.
This research will provide valuable insights into the most effective treatments for DRA, aiming to enhance the well-being and recovery of postpartum women.
Detailed description
Overview
This clinical trial is designed to investigate the efficacy of various interventions in treating Diastasis Recti Abdominis (DRA) among postpartum women. DRA is a condition characterized by the separation of the left and right sides of the rectus abdominis muscle, commonly occurring during and after pregnancy. This separation can lead to functional impairments such as lower back pain, pelvic floor dysfunctions, and a decrease in core stability, which significantly affects a woman's quality of life.
Purpose
The study aims to assess and compare the effectiveness of four different treatment modalities: Visceral Manipulation (VM), Kinesio Taping (KT), a combination of both VM and KT, and core strengthening exercises. The primary goal is to determine which treatment(s) most effectively reduce the inter-recti distance (IRD), thus alleviating the physical and functional symptoms associated with DRA. Secondary objectives include evaluating the impact of these treatments on associated pain levels, pelvic floor muscle strength, and urinary incontinence, which are common concerns among affected postpartum women.
Study Design
This randomized controlled trial will enroll participants from four major maternity hospitals across Karachi, Pakistan, ensuring a diverse participant pool. Upon meeting inclusion criteria, participants will be randomly assigned to one of the four intervention groups. Each group will receive a specific treatment protocol for six weeks, with assessments scheduled at baseline, the three-week midpoint, and upon completion at six weeks.
Group A: Participants will receive Kinesio Taping applied with approximately 70% tension in a crisscross pattern over the rectus abdominis muscle.
Group B: Participants will undergo Visceral Manipulation, focusing on enhancing the mobility and function of abdominal and pelvic organs.
Group C: This group will receive both VM and KT as combined therapies to maximize the therapeutic benefits.
Group D: Participants in this group will perform targeted core strengthening exercises designed to enhance muscle function and support abdominal healing.
Methodology
Treatment efficacy will be evaluated through a series of quantitative and qualitative measurements:
Inter-Recti Distance (IRD): Measured using the finger-width palpation method, this metric will directly assess the physical gap between the rectus abdominis muscles.
Pain Level: Assessed using the Visual Analogue Scale (VAS), allowing participants to report the intensity of their pain.
Pelvic Floor Muscle Strength: Evaluated using pressure biofeedback units, providing objective data on muscle functionality.
Urinary Incontinence: Measured via the Urinary Distress Inventory-6 (UDI-6), which quantifies symptoms of urinary incontinence.
Data Analysis
Data will be processed and analyzed using the Statistical Package for the Social Sciences (SPSS), version 21.0. Analysis of Covariance (ANCOVA) will be used to compare treatment effects across the groups, adjusting for potential confounders like age and BMI. Repeated measures ANOVA will be employed to evaluate changes within each group over time.
Ethical Considerations
The study has been reviewed and approved by an Institutional Review Board, ensuring that all procedures adhere to ethical guidelines. Participants will provide informed consent before participating, with a guarantee of confidentiality and the right to withdraw from the study at any time without penalty.
Significance
By rigorously evaluating these interventions, the study aims to provide clear, evidence-based guidance on the most effective treatment strategies for managing DRA in postpartum women. This research is crucial not only for enhancing individual patient care but also for informing clinical practices and potentially influencing public health policies related to maternal health and recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Visceral Manipulation | Experimental | Other: Visceral Manipulation TherapyParticipants in this arm will receive Visceral Manipulation (VM) therapy administered by a trained physical therapist. VM is a gentle manual therapy aimed at releasing restrictions within the visceral system to improve the mobility and function of the internal organs. The therapy sessions will focus on enhancing abdominal organ mobility and will be performed in a clinical setting. This treatment will be administered over a six-week period with sessions occurring once per week. |
| Kinesio Taping | Experimental | Other: Abdominal Kinesio TapingThis arm involves the application of Kinesio Tape (KT) to the abdominal area to support and stabilize the muscles affected by Diastasis Recti Abdominis. The KT will be applied in a crisscross manner to potentially facilitate muscle function and reduce the Inter-Recti Distance (IRD). Participants will receive taping once a week for six weeks, and the tape will be maintained throughout the week to ensure continuous support. |
| Combined Visceral Manipulation and Kinesio Taping | Experimental | Other: Combined Visceral Manipulation and Kinesio TapingParticipants in this arm will receive a combination of Visceral Manipulation and Kinesio Taping. The combination is intended to maximize the therapeutic effects by enhancing organ function with VM and providing muscular support with KT. The treatments will be administered concurrently during the same six-week period, with weekly sessions for both therapies. |
| Core Strengthening Exercises | Active comparator | Other: Postpartum Core Strengthening ProgramThis arm involves participants engaging in core strengthening exercises specifically designed for postpartum rehabilitation. The exercises aim to strengthen the transverse abdominis, multifidus, and pelvic floor muscles, which support the abdominal organs and improve core stability. Participants will perform these exercises under the supervision of a physical therapist three times a week for six weeks to ensure proper technique and progression. |
Who may qualify
- Ages
- 35 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- DRA: Finger width palpation shows >2.5 cm
- Postpartum females bearing at least 1 child
- Age between 35 to 45 years old
- Post-partum females who had gone through normal vaginal delivery, vacuum delivery, forceps delivery, and lower section caesarian section (at least 1 month after)
Key exclusion criteria (5 listed)
- Any other abdominal surgery
- Sensitivity with taping (specific for those will have KT)
- Diagnosed with abdominal hernia
- Open abdominal wound
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 |
|---|---|---|
| Visceral Manipulation TherapyVisceral Manipulation (VM) is a manual therapy consisting of gentle, specifically placed manipulations that encourage normal mobility, tone, and inherent tissue motion of the viscera and their connective tissues. These manipulations can potentially improve the structural integrity of the abdominal cavity and enhance the physiological functioning of the organs. VM will be administered by certified therapists trained in this specialized technique, focusing on reducing the Inter-Recti Distance (IRD) and associated symptoms of DRA. | Other | Visceral Manipulation |
| Abdominal Kinesio TapingKinesio Taping (KT) involves the application of a thin, stretchable tape over and around muscles to enhance function, reduce inflammation, and support muscles in movement on a 24hr/day basis. It is non-restrictive, allowing for full range of motion. In this study, KT will be applied in a crisscross pattern across the abdomen to support the abdominal muscles affected by DRA, potentially aiding in muscle function and reducing pain and discomfort. | Other | Kinesio Taping |
| Combined Visceral Manipulation and Kinesio TapingThis intervention combines Visceral Manipulation and Kinesio Taping to leverage the benefits of both modalities. The combination aims to enhance the functional and structural support of the abdominal region by improving organ function through VM and providing muscular support through KT. This dual approach is hypothesized to offer a synergistic benefit, potentially providing a more effective treatment for reducing IRD and improving overall abdominal function. | Other | Combined Visceral Manipulation and Kinesio Taping |
| Postpartum Core Strengthening ProgramThe Core Strengthening Program is designed to strengthen the deep core muscles, including the transverse abdominis, multifidus, and the pelvic floor muscles. Exercises will be tailored to accommodate postpartum women and will be progressively adjusted to match improvements in strength and endurance. The program includes supervised training sessions focusing on enhancing core stability, which is crucial for postpartum recovery and long-term spinal and pelvic health. | Other | Core Strengthening Exercises |
Primary outcome
Reduction in Inter-Recti Distance (IRD)
Time frame: Baseline, at the end of 3 weeks (mid-intervention), and at the end of 6 weeks (post-intervention)
This measure assesses the effectiveness of the interventions in reducing the Inter-Recti Distance (IRD) between the rectus abdominis muscles. The IRD will be measured using the finger-width palpation method, which involves placing fingers horizontally across the midline of the participant's abdomen at, above, and below the umbilicus. This method provides a direct and tangible measure of the gap between the rectus abdominis muscles, which is a primary physical manifestation of Diastasis Recti Abdominis (DRA).
1 secondary outcome
Improvement in Pelvic Floor Muscle Strength
Time frame: Baseline, at the end of 3 weeks (mid-intervention), and at the end of 6 weeks (post-intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Individual participant dataSharing planned: No. Individual Participant Data (IPD) from this study will not be shared publicly due to concerns over privacy and confidentiality, particularly given the sensitive nature of the health data involved. This decision aligns with the participant consent terms, which specified that data would be used solely for this research. Ethical considerations also dictate maintaining control over the data to ensure integrity and prevent potential misuse. Additionally, logistical limitations regarding the infrastructure necessary for secure data management preclude public sharing. This approach ensures compliance with ethical standards and protects participant trust and data security.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visceral Manipulation Therapy, Abdominal Kinesio Taping and Combined Visceral Manipulation and Kinesio Taping in people with Diastasis Recti and Diastasis Recti Abdominis (DRA), run by Health and Research-Insights at 1 site in Pakistan.
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 5 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: looking for participants now, as of the sponsor's last update on 9 Dec 2024. 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hafiz Sheraz Arshad, PhD Health Sciences (+923004009429, drhafizsheraz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Inter-Recti Distance (IRD) (time frame: Baseline, at the end of 3 weeks (mid-intervention), and at the end of 6 weeks (post-intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2024.