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IRCT20150210021034N3 IRCT 2019-12-30 Esfahan University of Medical Sciences Shoe inserts for elders with callus under the foot The effects of textured insoles on the balance of older people with callus formation under the foot: a controlled study 2017-08-11 anticipated 30 Complete https://irct.ir/trial/42794 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive. N/A Aging. Intervention 1: Intervention group: Using textured insole made with PVC that was in direct touch with the skin of the sole. This insole had 5mm diameter, 3mm height, and 10mm peak-to-peak distance circular projections. Intervention 2: Intervention group: Placebo insole. The pattern of the projections on the textured insole was scanned and printed on a PVC (banner) film. This printed film was attached on a plain/flat insole with 3mm thickness then used in the study. Intervention 3: Control group: A flat insole without any texture. This insole has 3mm thickness the same as international insoles to occupy the same room in the shoes. Yes - There is a plan to make this available What will be shared: The study data (excluding the personal details) can be shred with other researchers or systematic reviewers. When: No time limit is set. To whom: No specific limitation is considered. Conditions: No terms and conditions is considered for sharing the data. Where to obtain: People can sent their request to the correspondence and obtain the data. How to obtain: Request can be sent through an email. Comments:
public Ebrahim Sadeghi-Demneh
Hezar Jerib
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 5053 sadeghi@rehab.mui.ac.ir Esfahan University of Medical Sciences scientific Ebrahim Sadeghi-Demneh
Hezar Jerib St.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 5235 sadeghi@rehab.mui.ac.ir Esfarayen University of Medical Sciences Iran (Islamic Republic of) Age over 60 years Body mass index between 20 to 30 People with foot callus (grade 2 and 3) People with the history of two falls in the last six months 60 years no limit Both People with neurological conditions (e.g. Parkinson's disease and multiple sclerosis) Musculoskeletal conditions affect the balance People with vestibular dysfunction Having diabetes melitus L84 Corns and callosities Rehabilitation Placebo Treatment - Devices Intervention group: Using textured insole made with PVC that was in direct touch with the skin of the sole. This insole had 5mm diameter, 3mm height, and 10mm peak-to-peak distance circular projections. Intervention group: Placebo insole. The pattern of the projections on the textured insole was scanned and printed on a PVC (banner) film. This printed film was attached on a plain/flat insole with 3mm thickness then used in the study. Control group: A flat insole without any texture. This insole has 3mm thickness the same as international insoles to occupy the same room in the shoes. Ankle Joint Position sense (proprioception). Timepoint: All intervention was allocated in a straight forward session and outcomes were measured. Method of measurement: Ankle proprioception was measured using perception of the inclination whilst participants stood over an adjustable slope box with closed eyes. The mean velocity of center of pressure. Timepoint: All intervention was allocated in a straight forward session and outcomes were measured. Method of measurement: Participant's Postural stability on the platform were be measured with mean velocity of CoP excursion in open and closed eye conditions. The duration of each test was 60 seconds. Each tests repeated 3 times and average reported. Timed up and go test. Timepoint: All intervention was allocated in a straight forward session and outcomes were measured. Method of measurement: The time required to get up from a chair, walking 3 meters, turning back, and sitting on the chair was recorded. Esfahan University of Medical Sciences Approved 2017-07-23 ُthical committee of Isfahan University of Medical Sciences, Isfahan, Iran Hezar Jerib St. Isfahan Isfehan Iran (Islamic Republic of)