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
Increase balance and prevent falls in elderly women
Design
A randomized clinical trial on 42 people, using an equal block randomization method, unblinded, sample size is 250 with equal sample size in 6 parallel groups (4 intervention groups and 2 control groups).
Settings and conduct
Balance tests are performed in the Farzangan Foundation of Shiraz with the presence of the presenter and the clinic manager.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Elderly women 60-74 years; No history of falls leading to injury to the limb; Do not use aids to walk;
Ability to walk without assistance for at least 12 meters; Do not have any cognitive impairment or neuromuscular disease
Having a normal TUG.
Exclusion criteria: 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.
Intervention groups
study has 4 intervention groups(seniors who use 4 models of anti-slip socks) and 2 control groups(seniors with bare feet and seniors who use sandals)
Main outcome variables
Balance; fall rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180514039648N4
Registration date:2022-07-05, 1401/04/14
Registration timing:retrospective
Last update:2022-07-05, 1401/04/14
Update count:0
Registration date
2022-07-05, 1401/04/14
Registrant information
Name
Abdolrahim Asadollahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3725 1001
Email address
a_asadollahi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-30, 1401/02/10
Expected recruitment end date
2022-06-19, 1401/03/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
The effect of anti-slip socks on maintaining balance, panic and preventing falls in elderly Shirazi women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
• 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
Exclusion criteria:
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)
Age
From 60 years old to 74 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
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).
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz university of medical sciences
Street address
BLV. RAZI
City
Shiraz
Province
Fars
Postal code
7153675541
Approval date
2022-04-09, 1401/01/20
Ethics committee reference number
IR.SUMS.SCHEANUT.REC.1401.019
Health conditions studied
1
Description of health condition studied
nil.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
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
2
Description
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
3
Description
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
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Diagnosis
2
Description
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.
Category
Diagnosis
3
Description
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.
Category
Diagnosis
4
Description
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.
Category
Diagnosis
5
Description
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.
Category
Other
6
Description
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.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
07137251001
Full name of responsible person
Dr.Abdolrahim Asadollahi
Street address
BLV.RAZI
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 912 249 8890
Email
a_asadollahi@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Abdolrahim Asadollahi
Street address
BLV. RAZI
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 912 249 8890
Email
a_asadollahi@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shiraz University Of Medical Sciences
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Razmjouie
Position
Master student
Latest degree
Master
Other areas of specialty/work
Geriatrics
Street address
BLV. RAZI
City
Shirsz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1001
Email
a_asadollahi@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Abdolrahim Asadollahi
Position
Academic member
Latest degree
Ph.D.
Other areas of specialty/work
Geriatrics
Street address
BLV.RAZI
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 1001
Email
a_asadollahi@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Razmjouie
Position
Master student
Latest degree
Master
Other areas of specialty/work
Geriatrics
Street address
BLV.RAZI
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71 3725 7288
Email
a_asadollahi@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
In the process, data is collected.
When the data will become available and for how long
It takes about 1 month to collect data from the elderly under the auspices of the Foundation of Educated Scholars.
To whom data/document is available
People under the auspices of the Foundation of Educated Scholars
Under which criteria data/document could be used
Age requirements (60-74 years)
Gender condition (elderly woman)
No history of falls leading to limb damage
From where data/document is obtainable
Educated Scholars Foundation of Shiraz
What processes are involved for a request to access data/document
Samples are collected by performing equilibrium tests and classifying them.