Evaluation of the effect of kinesiotape on gait performance and fatigue in patients over 50 years old with intermittent claudication referred to Sina hospital: A single-blind randomized clinical trial

Evaluation of the effect of kinesiotape on gait performance and fatigue in patients with intermittent claudication

Randomized, single blinded parallel group trial on 30 patients. The distribution of candidates will be done by block randomization and random numbers table using Random Allocation Software.

The intended intervention includes the use of kinesiotape in treatment and control groups. In treatment group, kinesiotape will be attached from the origin of the gastrocnemius muscle in two directions, towards the insertion point of this muscle on the heel bone. In the control group, a kinesiotape will be attached to the superior part of the gastrocnemius horizontally, almost perpendicular to this muscle. All stages of this study will be performed in the sports medicine department of Sina Hospital and in this study, only the data analyzer is blinded.

The inclusion Criteria consists of Ankle-Brachial Index <0.9, patients with symptomatic peripheral arterial disease, age over 50 years and intermittent claudication stage 2 and 3 in the Rutherford classification. The exclusion criteria consists of having critical organ ischemia, pain while resting, amputated limb, having a respiratory disease, contraindications for kinesiotape application

The intended intervention includes the use of kinesiotape with therapeutic protocol (intervention group) or non-therapeutic and ineffective protocol (control group) on patients with peripheral arterial disease and intermittent claudication.

6 Minutes Walk Test (distance covered by walking in 6 minutes); Claudication Pain Distance; Claudication Pain Time ; Maximal Walking Distance (until the appearance of symptoms); Maximal Walking Time (until the appearance of symptoms) ;American Orthopedic Foot and Ankle Score (AOFAS)

The distribution of volunteers was done by random block method with blocks of two, three, four and six (15 places in total) and one group was named with the symbol A and the other group with the symbol B. Using the random allocation table of the "Random Allocation Software 2.0", the assignment of candidates to the positions within the blocks was done. The sample allocation ratio will be 1:1 and volunteers will be placed in two groups receiving kinesiotape therapy (A) or ineffective kinesiotype (B). Then, based on the obtained blocks and according to the order of the allocation sequence, one of two types of intervention is performed.

In this study, the patient and the researcher are fully aware of the type of treatment received by each patient. In the following, the collected data is provided to the analyst in raw form, but information about whether each of these data belongs to the treatment group or the control group is not provided to the analyst and in other words, in this study, the analyst will be blinded.

The present study has been registered as a proposal for the thesis of sports medicine residency. The dissertation resulting from this proposal including participants' data (all data), study protocol, statistical analysis and study report (including all variables) will be provided to Tehran University of Medical Sciences and Sports Medicine Department. It should be noted that after the dissertation is approved, an article containing all the items mentioned will be published in one of the journals relevant to the research topic. It should be noted that access to detailed data that were not published in the final report or article, requires communication with the researcher in charge of the study.

The present study started on 23/9/2022 and for all stages until the submission of the dissertation, a period of two years is predicted. The data obtained from this research will be presented in the form of an article after the dissertation is approved (end of 2 years) for publication. Access to the detailed data that were not published in the final report or article will be possible after the publication of the article through direct contact with the researcher in charge of the study.

The data obtained from this research will be available to all applicants and there will be no restrictions.

There is no restriction on the use, dissemination or processing of the data in this study, provided that correspondence is sent via email or other means to the researcher in charge of the study and the necessary permission is issued by the researcher in charge.

To access the information in this study, the applicant can contact the researcher in charge of this study by e-mail or telephone.

The license to use the information is issued to the applicant as soon as possible after receiving and viewing the e-mail or making a phone call, and then the requested information will immediately sent to the applicant via e-mail.