Diastasis RectiNCT04932772
Abdominal Muscles Recovery Response to Kinesiotaping in Women With Postnatal Diastasis
A study testing Kinesiotaping and Abdominal Exercises in people with Diastasis Recti, run by October 6 University at 1 site in Egypt.
Trial summary
This study aims to investigate abdominal muscle recovery in response to KT by using objective method for assessment as digital caliper, and waist circumference. KT technique will include rectus abdominis, internal and external oblique muscles among females after normal vaginal delivery. Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- Diastasis Recti
- What is being tested?
- Kinesiotaping and Abdominal Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 15 May 2021to 15 Mar 2022
- 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 25 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age will range from 25-35 years.
- All women give birth by normal vaginal delivery.
- Diastasis recti more than 2.5 cm at any point along linea alba.
- Body mass index (BMI) less than 30 kg/m2.
- After the end of Puerperium period i.e. after eight weeks postnatal.
Who cannot join
- Women with skin over sensitivity to tape.
- Women with abdominal skin diseases.
- Abdominal hernia.
- Previous cesarean section.
- Multiple pregnancies more than 3 times.
- Other abdominal or back operation.
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- Pregnancy related complications such as polyhydramnios, fetal macrostomia, diabetes, and hypertension.
- Spinal disorders.
- Lower limbs deformities.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
October 6 University Hospital
Al Ḩayy Ath Thāmin, Giza Governorate, 12511
Mohammed K Elarabi, BSc., 00201145554592, mohamedkhalaf.pt@o6u.edu.eg
Mohammed K Elarabi, BSc.
About this study
Official title: Abdominal Muscles Recovery Response to Kinesiotaping in Women With Postnatal Diastasis Recti: a Randomized Controlled Trial
This study aims to investigate abdominal muscle recovery in response to KT by using objective method for assessment as digital caliper, and waist circumference. KT technique will include rectus abdominis, internal and external oblique muscles among females after normal vaginal delivery.
- Conditions
- Diastasis Recti
- Being tested
- Kinesiotaping, Abdominal Exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KinesiotapingOther
Also called KT Tape, Medical Tape
Technique: Include Rectus Abdominas Muscles (RAM), Oblique Abdominal Muscles (OAM). Tape will be applied on RAM using muscles technique from origin to insertion of muscle with a tension between15-35%. Band will be start on symphysis pubis with no tension and then women make stretch on the abdominal region by deep abdominal inspiration and will end at xyphoid process. Finally will perform on the right and left external oblique muscles the procedure will be start with no tension from bottom and of 6-12 ribs and then the hip will be place in flexion and rotation to opposite direction and the band will tape on pubic bone with tension between 15-35% (Kase et al., 2003).
Abdominal ExercisesOther
Women in group B will receive abdominal muscles exercise (2 sessions/ week) for eight weeks. This program will be applied in both group A and B. The women will repeat the same exercise program on other days as home routine. This program is proposed by Kamel and Yousif, 2017, as based on the literature (Kamel and Yousif, 2017), there is no golden standard exercise program for DRAM. Illustrations of the exercises will be provided, so that the women could repeat the same exercise program on other days as a home routine. All the exercises will be performed while the subject tied a scarf around her abdomen. The following proposed one included sit ups, reverse sit-ups, reverse trunk twists, and U-seat exercises (Fig. 5). Each exercise was repeated 20 times and was increased by four repetitions each week throughout the interventions. In addition, a respiratory rehabilitation maneuver to involve the abdominal muscles, especially the transverse abdominis will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Group A (kinesiotaping group) | Experimental | include 24 women will receive kinesiotaping combined with abdominal exercise (2sessions /week for eight weeks). Receives: Other: Kinesiotaping; Other: Abdominal Exercises |
| Group B (abdominal exercise group) | Active comparator | include 24 women will receive abdominal exercise only. Receives: Other: Abdominal Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Abdominal Caliper at 8 weeks
A nylon digital caliper (ISS carbon digital caliper, 0-75 / 0.01 mm) will be used to measure the inter-recti distance. The subject is positioned in a crook lying position on a portable floor mat without a pillow under her head, knees flexed to 90 degrees and hands relaxed on her thigh. Before the measurement the investigator marks the reference points with a tape measure and a removable pen on the abdominal wall: at the superior border of the umbilicus; 5 cm and 10 cm above the umbilicus; 2.5 cm and 5 cm below the umbilicus. Then while the subject was exhaling, she is instructed to lift her head and shoulders up, slide her hands towards her knees, until the inferior angle of scapulae are just off the mat. She maintains the curl-up for three seconds while the measurement was taken. Meanwhile the instructor palpated the medial borders of the rectus abdominis muscle, put the caliper to the measurement point and measured the inter-rectum diastasis (IRD).
Measured: Baseline and after 8 Weeks
Secondary outcomes (3)
Change from Waist circumference at 8 weeks
It will be used for evaluating the recovery of the abdominal muscles by using tape measurement according to the standard set out by the world health organization when women in standing position at end of normal expiration without compression on skin.
Measured: Baseline and after 8 Weeks of training
Change from Abdominal strength and endurance test one minute sit-up test at 8 weeks
For assessment abdominal muscles endurance women will be lie down on exercise mat with knees bent and hand placed across the chest or on ears. The women feet are held by one physiotherapist. The examiner will ask the participant to go and simultaneously start stop watch. On listening the command the women will be lifting her upper body and touch knees with elbows and perform the same as many times as possible for next one minute. This procedure includes three trails of sit-ups test each for one minute, the final score will be the best of three attempts for assessment abdominal muscles strength. A 70° wood support was placed at the back of the patient.
Measured: Baseline and after 8 Weeks of training
Change from The Oswestry Low Back Pain Disability Questionnaire at 8 weeks
The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluator's use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools. The questionnaire include 10 sections. results will be calculated from the sum of the scores in each of 10 sections. Each section includes ratings from ZERO (no problem) to FIVE (complete disability). Section 1, pain intensity, section 2, personal care (washing, dressing etc.), section 3, lifting, section 4, walking, section 5, sitting, section 6, standing, section 7, sleeping, section 8, sex life (if applicable), section 9, social life, section 10, travelling. The score is calculated as: 100 x (sum of the scores in each section / number of sections scored X5). Minimum = 0, maximum = 100. Higher scores mean a worse outcome.
Measured: Baseline and after 8 Weeks of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start15 May 2021
- Primary completion15 Mar 2022 (estimated)
- Study completion15 Mar 2022 (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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Khalaf Sayed ElArabi, October 6 University
- Investigators
- Dalia M Kamel, Professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04932772
- Sponsor's protocol ID
- 012/003222
- Status last verified
- Jun 2021
- First submitted
- 4 Jun 2021
- Last updated
- 29 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all of the individual participant data collected during the trial and after deidentification
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdominal Muscles Recovery Response to Kinesiotaping in Women With Postnatal Diastasis Recti: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04932772
- Acronym / sponsor ID
- 012/003222
- Conditions
- Diastasis Recti
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 15 May 2021 (actual)
- Primary completion
- 15 Mar 2022 (estimated)
- Study completion
- 15 Mar 2022 (estimated)
- First posted
- 21 Jun 2021 (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 study aims to investigate abdominal muscle recovery in response to KT by using objective method for assessment as digital caliper, and waist circumference. KT technique will include rectus abdominis, internal and external oblique muscles among females after normal vaginal delivery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (kinesiotaping group) | Experimental | Other: Kinesiotaping, Other: Abdominal Exercisesinclude 24 women will receive kinesiotaping combined with abdominal exercise (2sessions /week for eight weeks). |
| Group B (abdominal exercise group) | Active comparator | Other: Abdominal Exercisesinclude 24 women will receive abdominal exercise only. |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age will range from 25-35 years.
- All women give birth by normal vaginal delivery.
- Diastasis recti more than 2.5 cm at any point along linea alba.
- Body mass index (BMI) less than 30 kg/m2.
- After the end of Puerperium period i.e. after eight weeks postnatal.
Key exclusion criteria (9 listed)
- Women with skin over sensitivity to tape.
- Women with abdominal skin diseases.
- Abdominal hernia.
- Previous cesarean section.
- Multiple pregnancies more than 3 times.
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 |
|---|---|---|
| KinesiotapingAlso: KT Tape, Medical TapeTechnique: Include Rectus Abdominas Muscles (RAM), Oblique Abdominal Muscles (OAM). Tape will be applied on RAM using muscles technique from origin to insertion of muscle with a tension between15-35%. Band will be start on symphysis pubis with no tension and then women make stretch on the abdominal region by deep abdominal inspiration and will end at xyphoid process. Finally will perform on the right and left external oblique muscles the procedure will be start with no tension from bottom and of 6-12 ribs and then the hip will be place in flexion and rotation to opposite direction and the band will tape on pubic bone with tension between 15-35% (Kase et al., 2003). | Other | Group A (kinesiotaping group) |
| Abdominal ExercisesWomen in group B will receive abdominal muscles exercise (2 sessions/ week) for eight weeks. This program will be applied in both group A and B. The women will repeat the same exercise program on other days as home routine. This program is proposed by Kamel and Yousif, 2017, as based on the literature (Kamel and Yousif, 2017), there is no golden standard exercise program for DRAM. Illustrations of the exercises will be provided, so that the women could repeat the same exercise program on other days as a home routine. All the exercises will be performed while the subject tied a scarf around her abdomen. The following proposed one included sit ups, reverse sit-ups, reverse trunk twists, and U-seat exercises (Fig. 5). Each exercise was repeated 20 times and was increased by four repetitions each week throughout the interventions. In addition, a respiratory rehabilitation maneuver to involve the abdominal muscles, especially the transverse abdominis will be performed. | Other | Group A (kinesiotaping group), Group B (abdominal exercise group) |
Primary outcome
Change from Abdominal Caliper at 8 weeks
Time frame: Baseline and after 8 Weeks
A nylon digital caliper (ISS carbon digital caliper, 0-75 / 0.01 mm) will be used to measure the inter-recti distance. The subject is positioned in a crook lying position on a portable floor mat without a pillow under her head, knees flexed to 90 degrees and hands relaxed on her thigh. Before the measurement the investigator marks the reference points with a tape measure and a removable pen on the abdominal wall: at the superior border of the umbilicus; 5 cm and 10 cm above the umbilicus; 2.5 cm and 5 cm below the umbilicus. Then while the subject was exhaling, she is instructed to lift her head and shoulders up, slide her hands towards her knees, until the inferior angle of scapulae are just off the mat. She maintains the curl-up for three seconds while the measurement was taken. Meanwhile the instructor palpated the medial borders of the rectus abdominis muscle, put the caliper to the measurement point and measured the inter-rectum diastasis (IRD).
3 secondary outcomes
Change from Waist circumference at 8 weeks
Time frame: Baseline and after 8 Weeks of training
Change from Abdominal strength and endurance test one minute sit-up test at 8 weeks
Time frame: Baseline and after 8 Weeks of training
Change from The Oswestry Low Back Pain Disability Questionnaire at 8 weeks
Time frame: Baseline and after 8 Weeks of training
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2021.
- Individual participant dataSharing planned: Yes. all of the individual participant data collected during the trial and after deidentification
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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.
Dalia M Kamel, Professor study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesiotaping and Abdominal Exercises in people with Diastasis Recti, run by October 6 University at 1 site in Egypt.
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 9 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: status not confirmed, as of the sponsor's last update on 29 Jun 2021. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammed K Sayed Elarabi, Bsc. (00201145554592, mohamedkhalaf.pt@o6u.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Abdominal Caliper at 8 weeks (time frame: Baseline and after 8 Weeks). 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 29 Jun 2021.