Abdominal Muscles Recovery Response to Kinesiotaping in Women With Postnatal Diastasis

NCT04932772 | Unknown

• 1 other identifier: 012/003222
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diastasis Recti

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline and after 8 Weeks

Secondary Outcomes (3)

• Change from Waist circumference at 8 weeks

  Baseline and after 8 Weeks of training

• Change from Abdominal strength and endurance test one minute sit-up test at 8 weeks

  Baseline and after 8 Weeks of training

• Change from The Oswestry Low Back Pain Disability Questionnaire at 8 weeks

  Baseline and after 8 Weeks of training

Study Arms (2)

Group A (kinesiotaping group)

EXPERIMENTAL

include 24 women will receive kinesiotaping combined with abdominal exercise (2sessions /week for eight weeks).

Other: Kinesiotaping; Other: Abdominal Exercises

Group B (abdominal exercise group)

ACTIVE COMPARATOR

include 24 women will receive abdominal exercise only.

Other: Abdominal Exercises

Interventions

Kinesiotaping OTHER

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).

Also known as: KT Tape, Medical Tape

Group A (kinesiotaping group)

Abdominal Exercises OTHER

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.

Group A (kinesiotaping group); Group B (abdominal exercise group)

Eligibility Criteria

• Age: 25 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Pregnancy related complications such as polyhydramnios, fetal macrostomia, diabetes, and hypertension.
• Spinal disorders.
• Lower limbs deformities.

Sponsors & Collaborators

• October 6 University: lead

Study Sites (1)

October 6 University Hospital

Al Ḩayy Ath Thāmin, Giza Governorate, 12511, Egypt

RECRUITING

Study Officials

• Dalia M Kamel, Professor

  Cairo University

  STUDY CHAIR

Central Study Contacts

Mohammed K Sayed Elarabi, Bsc.

CONTACT

00201145554592; mohamedkhalaf.pt@o6u.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Demonstrator, Department of Physical Therapy for Women's health, Faculty of Physical Therapy

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: June 21, 2021
• Study Start: May 15, 2021
• Primary Completion: March 15, 2022
• Study Completion: March 15, 2022
• Last Updated: June 29, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 6 months after study publication
• Access Criteria: email: mohamedkhalaf.pt@o6u.edu.eg

Locations

EG (1)