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IRCT20171122037576N5 IRCT 2022-10-26 Shiraz University of Medical Sciences The effect of medical insole on elderly balance Comparing the effect of medical insoles with Non-Slip Socks on balance and the fear of falling in the elderly 2022-11-22 anticipated 60 Complete https://irct.ir/trial/66089 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Individuals who enter the study are placed in 4 groups by permutation block randomization method. It should be noted that the examiners of this study are unaware of the steps of randomization and registration of participants and this will be done by another person. N/A Elderly. Intervention 1: Intervention group: Group 1: There are 15 people in this group, and the fear of falling questionnaire and TUG, BBS-9, FAB tests are taken. Then, this group will be given a model of anti-slip socks with silicone soles. The use of socks can affect the contact friction of the foot with the ground surface and by catching the slip of the heel, it can maintain balance. Then they are asked to wear said socks at home for a month. After one month, the above tests will be taken again from the group and the questionnaires will be completed and the results will be compared before and after. Intervention 2: Intervention group: Group 2: There are 15 people in this group, and the fear of falling questionnaire and TUG, BBS-9, and FAB tests are taken. Then this group will be given a normal sock model + textured insole. Textured insoles provide sensory input to the entire foot area and provide tactile stimulation to plantar mechanoreceptors created by ridges on the surface of the insoles, which increase attention and sensory input in the sole. They are then asked to Wear said socks at home for one month. After one month, the above tests will be taken again from the group and the questionnaires will be completed and the results will be compared before and after. Intervention 3: Intervention group: Group 3: There are 15 people in this group, and the fear of falling questionnaire and TUG, BBS-9, FAB tests are taken. Then this group will be given a non-slip sock model with a silicone sole + insole. Using socks can affect the contact friction of the foot with the ground surface and help maintain balance by catching the slip of the heel. Also, insoles increase attention and sensory input in the soles of the feet and can increase the stability of the standing position of young and elderly people in blindfolded conditions. Then, they are asked to wear the said insole socks at home for a month. After one month, the above tests will be taken again from the group and the questionnaires will be completed and the results will be compared before and after. Intervention 4: Control group: Group 4: Due to the fact that the elderly spend considerable time at home and their common footwear at home is socks, sandals or bare feet, as a result, the control group of this study is the elderly with bare feet. There are 15 people in this group, and the fear of falling questionnaire and TUG, BBS-9, FAB tests are taken. After one month, the above tests will be taken again from the group and the questionnaires will be completed and the results will be compared before and after. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Fatemeh Razmjouie
Abiverdi St
Shiraz Iran (Islamic Republic of) 7194733669 +98 71 3627 1551 hadadim@sums.ac.ir Shiraz University of Medical Sciences scientific Dr. Mohammad Haddadi
Abivardi St
Shiraz Iran (Islamic Republic of) 7194733669 +98 71 3627 1551 hadadim@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Age conditions (60 years and above) No history of falls resulting in damage to the lower limbs No use of aids for walking Ability to walk without assistance at least up to 12 meters Not having any cognitive impairment or neurological or muscular disease( based on the MMSE test) 60 years no limit Both Reluctance to continue participating in the study Orthopedic conditions that cause walking disorders or recent injuries Occurrence of stressful events such as death and loss of family members, accidents or new acute diseases Unstable medical conditions and cognitive impairment Acute conditions Psychiatric or under treatment for mental disorders Diagnosis Diagnosis Diagnosis Other Intervention group: Group 1: There are 15 people in this group, and the fear of falling questionnaire and TUG, BBS-9, FAB tests are taken. Then, this group will be given a model of anti-slip socks with silicone soles. The use of socks can affect the contact friction of the foot with the ground surface and by catching the slip of the heel, it can maintain balance. Then they are asked to wear said socks at home for a month. After one month, the above tests will be taken again from the group and the questionnaires will be completed and the results will be compared before and after. Intervention group: Group 2: There are 15 people in this group, and the fear of falling questionnaire and TUG, BBS-9, and FAB tests are taken. Then this group will be given a normal sock model + textured insole. Textured insoles provide sensory input to the entire foot area and provide tactile stimulation to plantar mechanoreceptors created by ridges on the surface of the insoles, which increase attention and sensory input in the sole. They are then asked to Wear said socks at home for one month. After one month, the above tests will be taken again from the group and the questionnaires will be completed and the results will be compared before and after. Intervention group: Group 3: There are 15 people in this group, and the fear of falling questionnaire and TUG, BBS-9, FAB tests are taken. Then this group will be given a non-slip sock model with a silicone sole + insole. Using socks can affect the contact friction of the foot with the ground surface and help maintain balance by catching the slip of the heel. Also, insoles increase attention and sensory input in the soles of the feet and can increase the stability of the standing position of young and elderly people in blindfolded conditions. Then, they are asked to wear the said insole socks at home for a month. After one month, the above tests will be taken again from the group and the questionnaires will be completed and the results will be compared before and after. Control group: Group 4: Due to the fact that the elderly spend considerable time at home and their common footwear at home is socks, sandals or bare feet, as a result, the control group of this study is the elderly with bare feet. There are 15 people in this group, and the fear of falling questionnaire and TUG, BBS-9, FAB tests are taken. After one month, the above tests will be taken again from the group and the questionnaires will be completed and the results will be compared before and after. Balance. Timepoint: Before the intervention and one week after the end of the intervention. Method of measurement: TUG and BBS-9 and FAB tests in person during periodical examinations. Fear of falling. Timepoint: Before the intervention and one week after the end of the intervention. Method of measurement: FES-I short questionnaire in person during periodical examinations. Shiraz university of medical sciences Approved 2022-09-14 Ethics Committees of Shiraz School of Rehabilitation Sciences School of Rehabilitation Sciences Abiverdi 1 St. Chamran Blvd. Shiraz Iran Shiraz Fars Iran (Islamic Republic of)