Effects of Kinesio Taping over stretched abdominal muscles following pregnancy

ISRCTN	ISRCTN36874773
DOI	https://doi.org/10.1186/ISRCTN36874773
Secondary identifying numbers	SUB.E060.19.001

Submission date: 01/12/2020
Registration date: 23/12/2020
Last edited: 17/01/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Abdominal rectus diastasis (RAD) is when the tummy muscles over-stretch during pregnancy and separate down the midline.
This study will investigate the use of different types of tape to control RAD following pregnancy.

Who can participate?
Women with RAD following childbirth

What does the study involve?
The participants are randomly assigned to one of two groups: the KT group (intervention), in which KT tapes were applied, and the sham KT group (control, sham intervention), in which non-stretch tapes were used (cloth surgical tape). In all participants, a palpation assessment of RAD was conducted and the inter-recti distance was measured using a digital caliper at three sites, at the umbilicus and 4.5 cm above and below it.

What are the possible benefits and risks of participating?
Benefits: getting to know the possibilities of RAD treatment, possible therapeutic benefits after using Kinesio Taping tapes. Risks: skin allergies from the use of tapes.

Where is the study run from?
Wroclaw Medical University (Poland)

When is the study starting and how long is it expected to run for?
December 2017 to December 2021

Who is funding the study?
Ministry of Science and Higher Education in Poland

Who is the main contact?
Dr K. Ptaszkowski, kuba.ptaszkowski@umed.wroc.pl

Contact information

Dr Kuba Ptaszkowski
Scientific

Grunwaldzka 2
Wrocław
50-355
Poland

ORCID ID	0000-0002-5690-5226
Phone	+48 1 784 18 13
Email	kuba.ptaszkowski@umed.wroc.pl

Study information

Study design	Interventional randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	No participant information sheet available
Scientific title	Effects of Kinesio Taping on rectus abdominis diastasis in postpartum women
Study acronym	KTonRAD
Study objectives	The primary objective of this study is a palpation assessment of rectus abdominis diastasis (RAD) in postpartum women before and after the application of Kinesio Taping (KT) tapes and a subsequent comparison of the results with those from a sham intervention group. The expectation is that RAD will decrease due to the application of KT tapes. A secondary objective is an electromyographic assessment of the effect of Kinesio Taping on the rectus abdominis. The hypothesis is that the bioelectrical activity of the muscles will increase as a result of the KT tapes application.
Ethics approval(s)	Approved 21/12/2017, Institutional Review Board at Wroclaw Medical University (ul. Pasteura 1, 50-367 Wrocław, Poland; +48 71 784 17 10; bioetyka@umed.wroc.pl), ref: KB – 43/2018
Health condition(s) or problem(s) studied	Rectus abdominis diastasis (RAD) in postpartum women
Intervention	The participants were randomly assigned to one of two groups: the KT group (intervention), in which KT tapes were applied, and the sham KT group (control, sham intervention), in which non-stretch tapes were used (cloth surgical tape). The application of KT tapes in the intervention group, using the corrective (mechanical) technique with a 75 - 100% tension range. In the control group, non-stretch tapes were used (cloth surgical tape). The tapes were placed perpendicularly to the rectus abdominis in the form of 2.5 cm-wide strips along the entire length of the muscle, crossing the midline of the linea alba. The application period was 48 hours. After that time, the tapes were removed and the measurements for the width of RAD and sEMG were repeated, and also 1 hour and 24 hours later (follow up). Randomization was carried out using computer-generated random numbers (simple randomization). The participants were randomly assigned to groups in a 1:1 ratio.
Intervention type	Other
Primary outcome measure	The inter-recti distance is measured using a digital caliper at three sites: at the umbilicus and 4.5 cm above and below it at baseline, 10 min after the intervention, and 1 and 24 h later
Secondary outcome measures	The bioelectrical activity of the rectus abdominis muscle is measured using surface electromyography at baseline, 10 min after the intervention, and 1 and 24 h later
Overall study start date	21/12/2017
Completion date	31/12/2021

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	50 in each group
Key inclusion criteria	1. RAD >2 cm at least at one of three sites 2. Postnatal period >6 weeks and <12 months 3. BMI <30 kg/m² 4. Consent to participate in the trial
Key exclusion criteria	1. Multiple pregnancies 2. Cesarean delivery 3. Other surgeries in the abdominal area
Date of first enrolment	10/01/2018
Date of final enrolment	29/12/2021

Locations

Countries of recruitment

Poland

Study participating centre

Wroclaw Medical University

Physical Therapy Department
Grunwaldzka 2
Wrocław
50-355
Poland

Sponsor information

Wrocław Medical University
University/education

Wybrzeże L. Pasteura 1
Wrocław
50-367
Poland

Phone	+48 71 784 10 11
Email	rn@umed.wroc.pl
Website	http://www.am.wroc.pl/en/
"ROR"	https://ror.org/01qpw1b93

Funders

Funder type

Government

The Ministry of Science and Higher Education in Poland

No information available

Results and Publications

Intention to publish date	31/12/2022
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication in a high-impact peer-reviewed journal.
IPD sharing plan	The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. Raw data (database taking into account the anonymity of patients), the data will become available from the end of the study, for 5 years. The research results will be passed on to other researchers in order to compare these results with the results of their own research.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Interim results article		28/10/2021	17/01/2023	Yes	No

Editorial Notes

17/01/2023: Publication reference added.
02/12/2020: Trial’s existence confirmed by Institutional Review Board at Wroclaw Medical University