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IRCT20140219016643N6 IRCT 2019-09-24 Iran University of Medical Sciences Comparison of the Effect of Computerized Custom Insole with Custom-fit Insole on the Function and Quality of Life in Elderly diabetic. Comparison of the Effect of Computerized Custom Insole with Custom-fit Insole on the Function and Quality of Life in Elderly diabetic. 2019-09-01 anticipated 28 Complete https://irct.ir/trial/41835 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. N/A Elderly with type 1 and type 2 diabetes. Intervention 1: 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. Intervention 2: Control group: All patients in the control group are made of custom-made insole. Yes - There is a plan to make this available What will be shared: Comparison of the Effect of Computerized Custom Insole with Custom-fit Insole on the Function and Quality of Life in Elderly diabetic. When: All study data are shareable after deleting the profile and contact number of the participants To whom: Accessibility for all people Conditions: Do not consider a particular item. Where to obtain: Contact by e-mail of corresponding author How to obtain: 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 Comments:
public Behshid Farahmand
Mather squre, Abkar Shahnazari Street, Madadkaran street, Faculty of Rehabilitation, Iran University of Medical Sciences
Tehran Iran (Islamic Republic of) 1545913487 +98 21 2222 0947 farahmand.b@iums.ac.ir Iran University of Medical Sciences scientific Behshid Farahmand
Mather Squre, Abkar Shahnazari Street, Madadkaran street, Faculty of Rehabilitation, Iran University of Medical Sciences
Tehran Iran (Islamic Republic of) 1545913487 +98 21 2222 0947 farahmand.b@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) 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 60 years 75 years Both Do not use medical insole during follow-up Failure to answer more than 10% of the questionnaire questions Unwillingness to continue follow-up E08.00 Diabetes mellitus due to underlying condition with hyperosmolarity without nonketotic hyperglycemic-hyperosmolar coma (NKHHC) Treatment - Devices Treatment - Devices 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. Control group: All patients in the control group are made of custom-made insole. 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. 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. Iran University of Medical Sciences Approved 2019-08-31 Iran University of Medical Sciences Mother Square, Abkar Shahnazari Street, Madadkaran Street, Faculty of Rehabilitation Sciences Tehran Tehran Iran (Islamic Republic of)