Comparison of the Effect of Computerized Custom Insole with Custom-fit Insole on the Function and Quality of Life in Elderly diabetic.
Design
A clinical trial with a control group, with parallel groups, A blind strai, randomized
Settings and conduct
Elderly study inclusion criteria to participate in the study as soon as they complete two questionnaires used in the study. After a mean period of 4-6 weeks, the questionnaire will again be available to patients by telephone or in person. After completing the questionnaires, in data analysis, pre-test and post-test will compare differences between foot and ankle and quality of life of each group, and also compare foot and ankle and quality of life of the two groups. accepted. Individuals will be unaware of the difference between the two groups.
Participants/Inclusion and exclusion criteria
Age between 60 and 75 years old; confirmation of diabetes and neuropathy by a specialist; physician approval to receive insole orthoses; absence of diabetic ulcer; ability to walk; minimum literacy for answering questionnaires.
Exclusion criteria: unwillingness to use orthoses during research; unwillingness to pursue research; failure to answer more than 10% of the questionnaire questions.
Intervention groups
The test group of computerized custom insole receives.
The control group custom-fit Insole receives
Main outcome variables
Quality of life, the foot and ankle pain, function, Alaymnt
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140219016643N6
Registration date:2019-09-24, 1398/07/02
Registration timing:registered_while_recruiting
Last update:2019-09-24, 1398/07/02
Update count:0
Registration date
2019-09-24, 1398/07/02
Registrant information
Name
Behshid Farahmand
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 0947
Email address
farahmand.b@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-01, 1398/06/10
Expected recruitment end date
2019-11-01, 1398/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Computerized Custom Insole with Custom-fit Insole on the Function and Quality of Life in Elderly diabetic.
Public title
Comparison of the Effect of Computerized Custom Insole with Custom-fit Insole on the Function and Quality of Life in Elderly diabetic.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 60 to 75 years
Diabetic patients with peripheral neuropathy
Physician approval to receive medical insole
Without diabetic foot ulcer
Ability to walk independently
Minimum literacy for answering questionnaires
Exclusion criteria:
Do not use medical insole during follow-up
Failure to answer more than 10% of the questionnaire questions
Unwillingness to continue follow-up
Age
From 60 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Randomized
Randomization description
Participants who refer to the Orthotics and Prosthetics Center are simple non-randomly divided in to Computerized Custom Insole and Custom-fit Insole groups. Insole type is written on paper and put in envelope. Each participant picks up one envelope. The envelope was opened by an expertorthotics and prosthetics and appropriate insole is made.
Blinding (investigator's opinion)
Single blinded
Blinding description
Only participants are kept blind in this study. Participants placed into the Computerized Custom Insole or Custom-fit Insole groups based on the envelops they have taken. Foot pressure was evaluated in all participants but these data is only used in the Computerized Custom Insole group. Also, the foot size of all patients is checked and these data is only used in the Custom-fit Insole group.The appearance, structure and material of the insoles are the same in the both groups.
Diabetes mellitus due to underlying condition with hyperosmolarity without nonketotic hyperglycemic-hyperosmolar coma (NKHHC)
Primary outcomes
1
Description
The Persian version of the Diabetes Quality of Life Questionnaire (DQOL) will be used to assess the quality of life in diabetic elderly.
Timepoint
Quality of life score is predicted before intervention 50 and after intervention 60.
Method of measurement
The Persian version of the Diabetes Quality of Life Questionnaire (DQOL) will be used to assess the quality of life in diabetic elderly.
2
Description
The Persian version of the American Foot and Ankle Assessment Questionnaire (AOFAS) will be used to evaluate the performance of the diabetic foot and ankle complex.
Timepoint
Foot and ankle performance score is predicted before intervention 50 and after intervention 75.
Method of measurement
The Persian version of the American Foot and Ankle Assessment Questionnaire (AOFAS) will be used to evaluate the performance of the diabetic foot and ankle complex.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: All patients in the test group are custom-made foam computer-manufactured insoles. To fabricate CAD-CAM insoles, these individuals were individually scanned with a Guy Capron device.
Category
Treatment - Devices
2
Description
Control group: All patients in the control group are made of custom-made insole.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Technical orthopedic mehr
Full name of responsible person
Mohammad Javad Hojati
Street address
Yazd city-Boulevard waiting for al-Qaem
City
Yazd
Province
Yazd
Postal code
8941776445
Phone
+98 35 3272 2945
Email
mohammad.javad7@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Kazem Malakoti
Street address
Hemat Highway, next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
research@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Behshid Farahmand
Position
Assistance Professor
Latest degree
Ph.D.
Other areas of specialty/work
Orthotics & Prosthetics
Street address
Mather squre, Abkar Shahnazari Street, Madadkaran street, Faculty of Rehabilitation, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 0947
Fax
+98 21 2222 0946
Email
farahmand.b@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Behshid Farahmand
Position
Assistance Professor
Latest degree
Ph.D.
Other areas of specialty/work
Orthotics & Prosthetics
Street address
Mather Squre, Abkar Shahnazari Street, Madadkaran street, Faculty of Rehabilitation, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 0947
Email
farahmand.b@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Behshid Farahmand
Position
Assistance professor
Latest degree
Ph.D.
Other areas of specialty/work
Orthotics & Prosthetics
Street address
Mather Squre, Abkar Shahnazari Street, Madadkaran Street, Faculty of Rehabilitation, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 0947
Email
arahmand.b@iums.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
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Comparison of the Effect of Computerized Custom Insole with Custom-fit Insole on the Function and Quality of Life in Elderly diabetic.
When the data will become available and for how long
All study data are shareable after deleting the profile and contact number of the participants
To whom data/document is available
Accessibility for all people
Under which criteria data/document could be used
Do not consider a particular item.
From where data/document is obtainable
Contact by e-mail of corresponding author
What processes are involved for a request to access data/document
If there is no precautionary statement from the journal which the article is printed, with contact by e-mail of corresponding author, information will be sent to the requesting person within less than one month