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IRCT20220910055929N1 IRCT 2023-02-24 Tehran University of Medical Sciences Evaluation of the effect of kinesiotape on performance of patients over 50 years old with intermittent claudication 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 2022-09-23 anticipated 30 Complete https://irct.ir/trial/65805 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. N/A Peripheral Arterial Disease. Intervention 1: Intervention group: In the intervention group, to attach the kinesiotape, the patient is placed on the bed in prone position and the leg will be in dorsiflexion. Then the spot is disinfected with alcohol and two strips are attached from the origin of the gastrocnemius muscle in two directions, one along the medial part of this muscle and the other along the lateral part of this muscle towards the final insertion point of this muscle on the heel bone. Intervention 2: Control group: In the control group, the patient will be placed in a prone position and the foot will be placed in a neutral position (without flexion or extension) and after disinfecting the area with alcohol, a kinesiotape will be attached to the superior part of the gastrocnemius horizontally, almost perpendicular to this muscle. Yes - There is a plan to make this available What will be shared: 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. When: 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. To whom: The data obtained from this research will be available to all applicants and there will be no restrictions. Conditions: 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. Where to obtain: To access the information in this study, the applicant can contact the researcher in charge of this study by e-mail or telephone. How to obtain: 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. Comments:
public Masoomeh Salahi
Department of Sports Medicine, Imam Khomeini Hospital Complex, Gharib Street, Keshavarz Boulevard
Tehran Iran (Islamic Republic of) ۱۴۱۹۷۳۳۱۴۱ +98 21 6658 1637 m-salahi@razi.tums.ac.ir Tehran University of Medical Sciences scientific Maryam Abolhasani
Imam Khomeini St., Sina Hospital
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6634 8500 dr_m_abolhasani@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patients with symptomatic peripheral arterial disease Age over 50 years Intermittent claudication stage 2 and 3 in the Rutherford classification system Ankle-Brachial Index < 0.9 50 years no limit Both Having critical organ ischemia Pain while resting Amputated limb Having a respiratory disease Contraindications for kinesiotape application such as: deep vein thrombosis, kidney failure, congestive heart disease, infection, wound, cancer and sensitivity to kinesiotape The patient's unwillingness to cooperate I73.9 Peripheral vascular disease, unspecified Treatment - Devices N/A Intervention group: In the intervention group, to attach the kinesiotape, the patient is placed on the bed in prone position and the leg will be in dorsiflexion. Then the spot is disinfected with alcohol and two strips are attached from the origin of the gastrocnemius muscle in two directions, one along the medial part of this muscle and the other along the lateral part of this muscle towards the final insertion point of this muscle on the heel bone. Control group: In the control group, the patient will be placed in a prone position and the foot will be placed in a neutral position (without flexion or extension) and after disinfecting the area with alcohol, a kinesiotape will be attached to the superior part of the gastrocnemius horizontally, almost perpendicular to this muscle. 6 Minutes Walk Test. Timepoint: Before the intervention, immediately and 72 hours after the intervention. Method of measurement: The patient is asked to walk a distance of 30 meters as many times as possible and at the end of the sixth minute, the distance traveled is measured. Claudication Pain Distance. Timepoint: Before the intervention, immediately and 72 hours after the intervention. Method of measurement: It is measured based on the distance covered until the onset of pain on the treadmill. Claudication Pain Time. Timepoint: Before the intervention, immediately and 72 hours after the intervention. Method of measurement: It is measured based on the time elapsed until the onset of pain on the treadmill. Maximal Walking Distance. Timepoint: Before the intervention, immediately and 72 hours after the intervention. Method of measurement: It is measured based on the distance covered up to the endurance limit on the treadmill. Maximal Walking Time. Timepoint: Before the intervention, immediately and 72 hours after the intervention. Method of measurement: Based on the time the patient has walked on the treadmill to the limit. American Orthopedic Foot and Ankle Score (AOFAS) assessment: The American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score is among the most commonly used instruments for measuring the outcome of treatment in patients who sustained a complex ankle or hindfoot injury. It combines a clinician-reported and a patient-reported part. Timepoint: Before the intervention, immediately and 72 hours after the intervention. Method of measurement: The American Orthopedic Foot and Ankle Score (AOFAS) has a four-point Likert scale. The total score is divided into three sub-headings, which include pain, function and alignment. A maximum score of 100 is obtained by combining patient-reported pain and function scores and physician-assessed gait (in terms of alignment). Tehran University of Medical Sciences Approved 2022-05-31 Research Ethics Committee of Sina Hospital - Tehran University of Medical Sciences Imam Khomeini St., Sina Hospital, Research Vice-Chancellor Tehran Tehran Iran (Islamic Republic of)