The effects of foot orthoses on balance, postural control and dynamic plantar pressure distribution in older adults with pronated foot-A randomized clinical control trial
Determination of the effect of foot orthoses on balance, postural control and dynamic plantar pressure distribution in older adults with pronated foot
Design
Present study is designed as a prospective, randomized-controlled parallel-group clinical trial.
Settings and conduct
En The research is conducted in the Shahrood city and participants are selected from the health centers of this city. Blinding is not done.
Participants/Inclusion and exclusion criteria
Inclusion criteria; Age over 65 years old; Confirmation of falling risk by falling screening algorithm; Pronated foot confirmation by foot posture index; Independent living in the community; Ability to walk without any help; and Medical certificate to participate in the study.
Exclusion criteria; Institutional older adults; A history of depression, anxiety, or other mental disorders confirmed by GDS-15; Presence of neurological or musculoskeletal problems; Lower extremity prosthetics; Peripheral neropathy or diabetes; Dementia confirmed by MMSE; Vision problem despite the glasses correction; and Previous use of foot orthosis
Intervention groups
Four types of commercial insoles are considered in this study; A) the soft insole (Shore A below 20) made of polyester and polyurethane sponge. B) Textured insoles, C) standard insoles (Shore A 25-30), and D) hard insoles (Shore A40-50), all made of polyester and ethylene vinyl acetate (EVA). The textured insole has convex circular beads with a center-to-center distance of approximately 10 mm. All insoles have heel cup with a height of approximately 15 mm, 25 mm arch support, and posting (the highest difference between the height of the inner and outer edges) is 15 mm. These insoles are designed and manufactured by Papaya Company.
Main outcome variables
Fear of falling ; Dynamic balance ; Static balance; Postural control; and Dynamic foot pressure distribution patterns.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170114031942N6
Registration date:2018-04-22, 1397/02/02
Registration timing:prospective
Last update:2018-04-22, 1397/02/02
Update count:0
Registration date
2018-04-22, 1397/02/02
Registrant information
Name
Aynollah Naderi
Name of organization / entity
Shahrood University of Technology
Country
Iran (Islamic Republic of)
Phone
+98 917 721 7462
Email address
ay.naderi@shahroodut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-11-22, 1397/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of foot orthoses on balance, postural control and dynamic plantar pressure distribution in older adults with pronated foot-A randomized clinical control trial
Public title
Effect of foot orthoses for older adults with pronated foot
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 65 years old
Confirmation of falling risk by falling screening algorithm
Pronated foot confirmation by foot posture index
Independent living in the community
Ability to walk without any help (for example, without a cane or walker)
Medical certificate to participate in the study
Exclusion criteria:
Institutional older adults (nursing home and hospitalized)
A history of depression, anxiety, or other mental disorders confirmed by GDS-15
Presence of neurological or musculoskeletal problems (such as a history of cardiovascular disease, Parkinson's disease, lower extremity surgery, significant orthopedic disorders or acute illness)
Lower extremity prosthetics
Peripheral neuropathy or diabetes
Dementia confirmed by MMSE
Vision problem despite the glasses correction
Previous use of foot orthosis
Age
From 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
Participants are firstly enrolled by one of the research colleagues. An independent assessor, blinded person who has no further involvement in the study creates a random allocation sequence using a computer Software prior to the initiation of the study that use to randomize participants with 1:1 allocation ratio. A block randomization design (block size of 8) are applied to ensure an equal number of participants in each group. Group allocation are concealed in sequentially numbered, opaque, sealed envelopes, and corresponding envelopes are opened after enrolled participants complete all baseline assessments.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of shahroud university of medical sciences
Street address
Seventh Tir Square, Shahroud
City
shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Approval date
2018-03-07, 1396/12/16
Ethics committee reference number
IR.shmu.REC.1396.194
Health conditions studied
1
Description of health condition studied
Older adult health
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Fear of falling
Timepoint
The fear of falling is measured before, immediately and 16 weeks after intervention.
Method of measurement
Fall Efficacy Scale International
2
Description
Dynamic balance
Timepoint
Dynamic balance is measured before, immediately and 16 weeks after intervention.
Method of measurement
Dynamic gait index
3
Description
Static balance
Timepoint
Static balance is measured before, immediately and 16 weeks after intervention.
Method of measurement
Frailty and Injuries: Cooperative Studies of Intervention Techniques–4
4
Description
Postural control
Timepoint
Posture control is measured before, immediately and 16 weeks after intervention.
Method of measurement
Footscan pressure plat
5
Description
Dynamic foot pressure distribution patterns
Timepoint
Dynamic foot pressure distribution patterns is measured before, immediately and 16 weeks after intervention.
Method of measurement
Footscan pressure plat
Secondary outcomes
1
Description
Comfort of the orthoses
Timepoint
The comfort of the orthoses is measured immediately after the intervention and 1 week after the intervention.
Method of measurement
Comfort Index of Orthotic
Intervention groups
1
Description
Soft insole group: This group receives a soft insole with Shore A below 20 made of polyester and polyurethane sponge.
Category
Prevention
2
Description
Textured insole group: This group receives textured insole with Shore A25-30 made polyester and ethylene vinyl acetate (EVA).
Category
Prevention
3
Description
Standard insole group: This group receives standard insole with Shore A25-30 made polyester and ethylene vinyl acetate (EVA).
Category
Prevention
4
Description
Hard insole group: This group receives hard insole with Shore A25-30 made polyester and ethylene vinyl acetate (EVA).
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahrood city
Full name of responsible person
Aynollah Naderi
Street address
Shahrood University of Technology, Tehran Road
City
shahroud
Province
Semnan
Postal code
3619995161
Phone
+98 23 3239 2204
Email
Ay.naderi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Technology
Full name of responsible person
Aynollah Naderi
Street address
Tehran avenue, Shahroud, Semnan province
City
Shahroud
Province
Semnan
Postal code
3619995161
Phone
+98 23 3239 2204
Email
ay.naderi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud University of Technology
Proportion provided by this source
50
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
2
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Hosein Ebrahimi
Street address
Shahrood, Seventh Tir Square, Shahrood University of Medical Sciences
City
Shahrood
Province
Semnan
Postal code
2322323333
Email
h_ebrahimi43@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud University of Medical Sciences
Proportion provided by this source
50
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
Shahrood University of Technology
Full name of responsible person
Aynollah Naderi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physical Education and Sports Science
Street address
Tehran avenue, Shahroud, Semnan Province
City
Shahroud
Province
Semnan
Postal code
3619995161
Phone
+98 23 3239 2204
Fax
Email
ay.naderi@shahroodut.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrood University of Technology
Full name of responsible person
Aynollah Naderi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physical Education and Sports Science
Street address
Tehran Avenue, Shahroud, Semnan Province
City
shahroud
Province
Semnan
Postal code
3619995161
Phone
+98 23 3239 2204
Email
Ay.naderi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahrood University of Technology
Full name of responsible person
Aynollah Naderi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Tehran avenue, Shahroud, Semnan Province
City
Shahroud
Province
Semnan
Postal code
3619995161
Phone
+98 23 3239 2204
Fax
Email
ay.naderi@shahroodut.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD