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IRCT20180514039648N4 IRCT 2022-07-05 Shiraz University of Medical Sciences The effect of anti-slip socks on maintaining balance, panic and preventing falls in elderly Shirazi women Effectiveness of Non-Slip Socks on Balance Control, Fear and Prevention of Fall in Older Female Members of the Farzanegan Foundation at Home: A Parallel RCT 2022-04-30 anticipated 42 Complete https://irct.ir/trial/63267 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: According to the quarterly review of the situation of companies producing and importing socks available in the Iranian market, 4 categories of socks with different designs have been advertised and identified as anti-slip socks for the elderly, pregnant women, medical staff and sports clubs. Also, by examining the physical mobility of the elderly at home in general, it was found that they work in this environment in two ways without bare feet (barefoot) with leather sandals. Therefore, this study is based on 4 models of socks, 4 groups of experimental groups and 2 groups as a control group (without cover and with sandals), Randomization description: In this parallel trial, at first, 250 elderly people who meet the inclusion criteria were selected and they were asked to complete the fear of falling questionnaire and we performed the TUG balance tests and Berg balance scale for them, and the elderly people whose fear of falling was scored 28-16 means that they have a fear of falling and normal balance, they are selected as samples. Every elderly person in Farzangan Foundation has an ID, and 42 people with their own ID were selected as the main sample and a demographic questionnaire was completed for them. With the membership number in Farzangan Foundation and registering the numbers in the software, which completely randomly places each number in a group, 42 people are selected from the 250 people who have the conditions and are distributed in equal blocks in the groups. Using Efron's equal block randomization using PASS version 15 software (the output of this software is presented as a table of random numbers that divides the sample into equal groups with equal chance and distribution of equal blocks) The sample is divided into 6 equal groups (7 people) (equal blocks is used with the aim of creating a balance in the number of samples allocated to each of the groups under study and an equal number of people are placed in all blocks) that 2 The group is selected as the control group and 4 groups as the experimental group. In other words, in order to randomize the generated groups and allocate them to the intervention and control groups, the software has been assigned a membership code in the Farzangan Foundation and randomly with equal blocks. N/A nil.. Intervention 1: Intervention group: Group 1: There are 6 people in this group who, after completing the questionnaire of fear of falling and performing balance and BERG balance tests, are given anti-slip socks of the first type, which is made of leather socks. The use of socks can affect the friction of the foot in contact with the ground, and in addition, due to the importance of the heel, anti-slip socks can try to help maintain balance by catching the heel slip. Then they are asked to use this type of sock at home for 2 months. After 2 months, they will be taken again from the group of balance tests, BERG balance tests and the questionnaire of fear of falling will be completed for them and the results will be compared before and after. Intervention 2: Intervention group: Group 2: There are 6 people in this group who, after completing the questionnaire of fear of falling and performing balance and BERG balance tests, are given anti-slip socks of the second type, which is made of silicone socks. The use of socks can affect the friction of the foot in contact with the ground, and in addition, due to the importance of the heel, anti-slip socks can try to help maintain balance by catching the heel slip. Then they are asked to use this type of sock at home for 2 months. After 2 months, they will be taken again from the group of balance tests, BERG balance tests and the questionnaire of fear of falling will be completed for them and the results will be compared before and after. Intervention 3: Intervention group: Group 3: There are 6 people in this group who, after completing the questionnaire of fear of falling and performing balance and BERG balance tests, are given anti-slip socks of thethird type, which is made of compressed plastic socks. The use of socks can affect the friction of the foot in contact with the ground, and in addition, due to the importance of the heel, anti-slip socks can try to help maintain balance by catching the heel slip. Then they are asked to use this type of sock at home for 2 months. After 2 months, they will be taken again from the group of balance tests, BERG balance testsand the questionnaire of fear of falling will be completed for them and the results will be compared before and after. Intervention 4: Intervention group: Group 4: There are 6 people in this group who, after completing the questionnaire of fear of falling and performing balance and BERG balance tests, are given anti-slip socks of the second type, which is made of silicone socks. The use of socks can affect the friction of the foot in contact with the ground, and in addition, due to the importance of the heel, anti-slip socks can try to help maintain balance by catching the heel slip. Then they are asked to use this type of sock at home for 2 months. After 2 months, they will be taken again from the group of balance tests, BERG balance tests and the questionnaire of fear of falling will be completed for them and the results will be compared before and after. Intervention 5: Control group: Group 1: The elderly spend a considerable amount of time at home, and the most common covering at home is socks, sandals, or bare feet. There are 6 people in this group who, after completing the questionnaire on fear of falling and performing balance and BERG balance tests, are not given special socks in this group and are asked to walk around the house barefoot. 2 months again, a balance sheet will be taken from the group of balance tests, BERG balance tests and a fall fear questionnaire will be completed for them, and the results will be compared before and after. Intervention 6: Control group: Group 2: The elderly spend a considerable amount of time at home, and the most common covering at home is socks, sandals, or bare feet. There are 6 people in this group who, after completing the questionnaire on fear of falling and performing balance and BERG balance tests, are not given special socks in this group and are asked to walk around in their sandals at home. 2 months again, a balance sheet will be taken from the group of balance tests, BERG balance tests and a fall fear questionnaire will be completed for them, and the results will be compared before and after. Yes - There is a plan to make this available What will be shared: In the process, data is collected. When: It takes about 1 month to collect data from the elderly under the auspices of the Foundation of Educated Scholars. To whom: People under the auspices of the Foundation of Educated Scholars Conditions: Age requirements (60-74 years) Gender condition (elderly woman) No history of falls leading to limb damage Where to obtain: Educated Scholars Foundation of Shiraz How to obtain: Samples are collected by performing equilibrium tests and classifying them. Comments:
public Fatemeh Razmjouie
BLV. RAZI
Shirsz Iran (Islamic Republic of) 7153675541 +98 71 3725 1001 a_asadollahi@sums.ac.ir Shiraz University of Medical Sciences scientific Dr.Abdolrahim Asadollahi
BLV.RAZI
Shiraz Iran (Islamic Republic of) 7153675541 +98 71 3725 1001 a_asadollahi@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) • Age requirements (60-74 years) Gender condition (female age) Willingness to participate in the study No history of falls leading to injury to the limb Do not use aids to walk Ability to walk without assistance at least 12 meters Do not have any cognitive impairment or neuromuscular disease (based on the observation and self-expression of the person and also using the personal file in the Farzanegan Foundation) Having a normal TUG 60 years 74 years Female Reluctance to attend the study Orthopedic conditions that cause recent gait impairment or injury Occurrence of stressful events such as death and loss of family members, accident or new illness Unstable medical conditions and cognitive impairment Acute psychiatric conditions or under treatment for mental disorders (reported by the elderly person and based on his / her file in Farzanegan Farhizgan Foundation) Diagnosis Diagnosis Diagnosis Diagnosis Other Other Intervention group: Group 1: There are 6 people in this group who, after completing the questionnaire of fear of falling and performing balance and BERG balance tests, are given anti-slip socks of the first type, which is made of leather socks. The use of socks can affect the friction of the foot in contact with the ground, and in addition, due to the importance of the heel, anti-slip socks can try to help maintain balance by catching the heel slip. Then they are asked to use this type of sock at home for 2 months. After 2 months, they will be taken again from the group of balance tests, BERG balance tests and the questionnaire of fear of falling will be completed for them and the results will be compared before and after. Intervention group: Group 2: There are 6 people in this group who, after completing the questionnaire of fear of falling and performing balance and BERG balance tests, are given anti-slip socks of the second type, which is made of silicone socks. The use of socks can affect the friction of the foot in contact with the ground, and in addition, due to the importance of the heel, anti-slip socks can try to help maintain balance by catching the heel slip. Then they are asked to use this type of sock at home for 2 months. After 2 months, they will be taken again from the group of balance tests, BERG balance tests and the questionnaire of fear of falling will be completed for them and the results will be compared before and after. Intervention group: Group 3: There are 6 people in this group who, after completing the questionnaire of fear of falling and performing balance and BERG balance tests, are given anti-slip socks of thethird type, which is made of compressed plastic socks. The use of socks can affect the friction of the foot in contact with the ground, and in addition, due to the importance of the heel, anti-slip socks can try to help maintain balance by catching the heel slip. Then they are asked to use this type of sock at home for 2 months. After 2 months, they will be taken again from the group of balance tests, BERG balance testsand the questionnaire of fear of falling will be completed for them and the results will be compared before and after. Intervention group: Group 4: There are 6 people in this group who, after completing the questionnaire of fear of falling and performing balance and BERG balance tests, are given anti-slip socks of the second type, which is made of silicone socks. The use of socks can affect the friction of the foot in contact with the ground, and in addition, due to the importance of the heel, anti-slip socks can try to help maintain balance by catching the heel slip. Then they are asked to use this type of sock at home for 2 months. After 2 months, they will be taken again from the group of balance tests, BERG balance tests and the questionnaire of fear of falling will be completed for them and the results will be compared before and after. Control group: Group 1: The elderly spend a considerable amount of time at home, and the most common covering at home is socks, sandals, or bare feet. There are 6 people in this group who, after completing the questionnaire on fear of falling and performing balance and BERG balance tests, are not given special socks in this group and are asked to walk around the house barefoot. 2 months again, a balance sheet will be taken from the group of balance tests, BERG balance tests and a fall fear questionnaire will be completed for them, and the results will be compared before and after. Control group: Group 2: The elderly spend a considerable amount of time at home, and the most common covering at home is socks, sandals, or bare feet. There are 6 people in this group who, after completing the questionnaire on fear of falling and performing balance and BERG balance tests, are not given special socks in this group and are asked to walk around in their sandals at home. 2 months again, a balance sheet will be taken from the group of balance tests, BERG balance tests and a fall fear questionnaire will be completed for them, and the results will be compared before and after. Fall. Timepoint: Before the intervention and one week after the end of the intervention. Method of measurement: Berg balance test and TUG test in person during periodical examinations. Maintain balance in the elderly. Timepoint: Before the intervention and one week after the end of the intervention. Method of measurement: Berg balance test and TUG test in person during periodical examinations. Reduce the fear of falling in the elderly. Timepoint: Before the intervention and one week after the end of the intervention. Method of measurement: Short version of the fear of falling questionnaire(FES-I ) in person during periodical examinations. Shiraz University Of Medical Sciences Approved 2022-04-09 Shiraz university of medical sciences BLV. RAZI Shiraz Fars Iran (Islamic Republic of)