Creating balance, optimal and stable gait in the elderly
Design
In this study, by designing a insole with a protrusion under the toe and medial arch support and widening the heel of the shoe, we increase the balance and as a result, create a stable gait for the elderly.The sample size of 15 elderly people is in an intervention group and we do not have a control group.
Settings and conduct
This study is performed in 15 Musculoskeletal Research Center of Isfahan University of Medical Sciences on 15 elderly people over 60 years old who have fallen at least once in the last 6 months and the parameters of gate and balance with medical insole intervention with shoes in these people by the device We will evaluate the gait analysis and force plate.
Participants/Inclusion and exclusion criteria
Conditions for entering the study:
- Elderly over 60 years
- Has fallen at least once in the last 6 months
Have the ability to walk independently inside and outside the home to perform daily activities.
Conditions for not entering the study:
People with neuromuscular diseases, diabetes, amputation
History of surgery or fracture in the lower limb during the last ten years
People taking balance medications
Intervention groups
A group will receive an insole and shoes and we do not have a control group
Main outcome variables
balance , gait
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201212049687N2
Registration date:2021-05-30, 1400/03/09
Registration timing:registered_while_recruiting
Last update:2021-05-30, 1400/03/09
Update count:0
Registration date
2021-05-30, 1400/03/09
Registrant information
Name
َAlireza Taheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 5053
Email address
taheri@rehab.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-22, 1400/03/01
Expected recruitment end date
2021-07-21, 1400/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of toe-grip bar with arch support and Heel shoe flare on balance and gait in the old people
Public title
The effect of insole and shoe changes on the balance and gait of the elderly
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Elderly over 60 years
falling at least once in the last 6 months
the ability to walk independently inside and outside the home to perform daily activities
Exclusion criteria:
People with neuromuscular diseases such as MS and Parkinson's
People with diabetes
Those who have a history of surgery or fractures in the lower extremities during the last ten years
Those who take drugs that upset the balance
People with amputations
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
street hezar jrib, isfahan university of medical sciences , rehabilitation school
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-05-11, 1400/02/21
Ethics committee reference number
IR.MUI.RESEARCH.REC.1400.062
Health conditions studied
1
Description of health condition studied
Elderly
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The ratio of the sample balance score to the standard score of the force plate device
Timepoint
Balance and gate measurements before and immediately after the intervention
Method of measurement
How to measure static stability and balance by the force plate device and evaluate the type of gait by the gait analysis
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Gait and balance parameters are evaluated by medical insole intervention with shoes in these people. To assess the balance, the force plate will be calculated while standing. People are asked to first stand on the force plate with shoes without insoles for 60 seconds and then in the stage Second, repeat this test with shoes with external flare made of hard rubber and insole with protrusion under the toe and arc support made of soft poly foam. Each step will be repeated 5 times. In the next step, to evaluate the parameters of the gait, we ask the person to look at the face without distraction and try to walk in a straight line with constant speed and length of steps in the gate laboratory. This test is first with shoes and then It will be repeated 5 times with shoes and insoles.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
kashany hospital
Full name of responsible person
Alireza Taheri
Street address
street Hezar jrib, isfahan university of medical sciences, rehabilitation school
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۱
Phone
+98 31 3792 5053
Email
taheri@rehab.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Javanmard Haghjo
Street address
street Hezar jrib, isfahan university of medcal sciences , rehabilitation school
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5053
Email
taheri@rehab.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
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
Esfahan University of Medical Sciences
Full name of responsible person
Alireza taheri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Orthopedics
Street address
Street Hezar jrib, isfahan university of medical sciences , rehabilitation shool
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5053
Email
taheri@rehab.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Alireza Taheri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Orthopedics
Street address
Street Hezar jrib, Isfahan university of medical sciences , rehabilitation shool
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5053
Email
taheri@rehab.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Alireza Taheri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Orthopedics
Street address
Street Hezar jrib , Isfahan university of medical sciences, rehabilitation school
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5053
Email
taheri@rehab.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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