To investigate the effects of textured insoles on the balance of older people with callus formation under the foot
Design
Clinical trial, parallel group design, with 30 participants
Settings and conduct
Participants were recruited form outpatient clinic in Alzahra hospital, Isfahan, Iran through a convenience sampling method.
Participants/Inclusion and exclusion criteria
Inclusion criteria were age over 60 years; Body mass index between 20 to 30; People with foot callus (grade 2 and 3); and the history of a fall in the last six months. Exclusion criteria included neurological and musculoskeletal conditions which affect the balance, vestibular dysfunction, and diabetes melitus.
Intervention groups
Interventions included textured and placebo insoles. The Placebo was a flat insole coverd with a printed film only illustrated the textured pattern. A flat insole without any texture was used as the control condition. This insole has 3mm thickness the same as international insoles to occupy the same room in the shoes.
Main outcome variables
The primary outcome measures were the upright postural stability, ankle joint position sense, and timed-up and go test.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150210021034N3
Registration date:2019-12-30, 1398/10/09
Registration timing:retrospective
Last update:2019-12-30, 1398/10/09
Update count:0
Registration date
2019-12-30, 1398/10/09
Registrant information
Name
Ebrahim Sadeghi-Demneh
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 5235
Email address
sadeghi@rehab.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-08-11, 1396/05/20
Expected recruitment end date
2018-01-10, 1396/10/20
Actual recruitment start date
2017-10-07, 1396/07/15
Actual recruitment end date
2018-05-31, 1397/03/10
Trial completion date
2018-05-31, 1397/03/10
Scientific title
The effects of textured insoles on the balance of older people with callus formation under the foot: a controlled study
Public title
Shoe inserts for elders with callus under the foot
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
People with neurological conditions (e.g. Parkinson's disease and multiple sclerosis)
Musculoskeletal conditions affect the balance
People with vestibular dysfunction
Having diabetes melitus
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ُthical committee of Isfahan University of Medical Sciences, Isfahan, Iran
Street address
Hezar Jerib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2017-07-23, 1396/05/01
Ethics committee reference number
IR.MUI.REC.1396.3.252
Health conditions studied
1
Description of health condition studied
Aging
ICD-10 code
L84
ICD-10 code description
Corns and callosities
Primary outcomes
1
Description
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.
2
Description
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.
3
Description
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.
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Rehabilitation
2
Description
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.
Category
Placebo
3
Description
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.