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The effect of minimal footwear on postural control during gait initiation in blind and sighted adolescents, with and without cognitive load

Protocol summary

Study aim
The effect of minimal footwear on postural control during gait initiation in blind and sighted adolescents, with and without cognitive load
Design
A quasi-experimental clinical trial, a control group, non-random allocation, and 20 patients.
Settings and conduct
This study, conducted at the IUMS School of Rehabilitation Science, will employ force plate data collection during dual-task and single-task conditions. In the single-task phase, to document the gait initiation for participants in both the blind and sighted groups, participants will first stand barefoot on the force plate. Standing will be in a free-standing, bipedal position with a stable posture. A verbal instruction will then be given to initiate movement (under three foot-covering conditions: barefoot, wearing conventional footwear, and wearing minimalist footwear) The dual-task phase will be created by combining the single-task with the second task, which involves reverse counting.
Participants/Inclusion and exclusion criteria
Eligibility The blind group must have a visual acuity (400/20), and blindness may be congenital or acquired, with a duration of at least three years. Participants aged 13 to 17 years and in good general health, with no motor or balance problems in either group. Exclusion - Musculoskeletal abnormalities (impair independent movement or balance, or limit ROM) - Presence of cognitive disorders. - Participant’s refusal.
Intervention groups
The shift of the COP in blind adolescents in the test group and in sighted adolescents in the control group will be examined under three foot-covering conditions (barefoot, wearing conventional footwear, and wearing minimalist footwear). Both groups will be assessed on gait initiation with and without reverse counting, considered as the second task, using a force plate.
Main outcome variables
Spatio-temporal parameters of the center of pressure movement Impulse

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250830067050N1
Registration date: 2025-11-03, 1404/08/12
Registration timing: prospective

Last update: 2025-11-03, 1404/08/12
Update count: 0
Registration date
2025-11-03, 1404/08/12
Registrant information
Name
Zahra Rahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3308 9985
Email address
zahra.rahimi670@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-11-11, 1404/08/20
Expected recruitment end date
2026-03-01, 1404/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of minimal footwear on postural control during gait initiation in blind and sighted adolescents, with and without cognitive load
Public title
Investigation of the Effect of Footwear on Balance
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
For the blind group: Visual acuity less than 400/20 (56) For the blind group: Blindness congenital or acquired by age 3 years For the blind group: Age between 13 and 17 years For the blind group: General health and absence of motor or balance disorders For the sighted (control) group: Normal vision with no history of visual impairment For the sighted (control) group: Age between 13 and 17 years For the sighted (control) group: General health and absence of motor or balance disorders
Exclusion criteria:
Musculoskeletal or neuromuscular abnormalities that would impair independent movement Any neuromuscular disease such as Parkinson’s disease, cerebellar or vestibular disorders Neurological diseases associated with balance impairment- Use of medications that disrupt walking or balance Presence of cognitive disorders as determined by the Neo personality questionnaire Limitation in the range of motion required for the hip, knee, and ankle joints for normal gait Lack of willingness to continue participation in the study
Age
From 13 years old to 17 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
In this study, blind adolescents will be assigned to the test group and sighted adolescents to the control group, and both groups will be assessed under identical conditions and with identical interventions. The objective of this study is to examine the impact of removing vision.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
research.ethics.iums
Approval date
2025-08-16, 1404/05/25
Ethics committee reference number
IR.IUMS.REC.1404.518

Health conditions studied

1

Description of health condition studied
Blindness
ICD-10 code
H54.0
ICD-10 code description
Blindness, both eyes

Primary outcomes

1

Description
Spatio-temporal parameters of the center of pressure during gait initiation
Timepoint
Immediate effect
Method of measurement
Force plate

2

Description
Impulse
Timepoint
Immediate effect
Method of measurement
Force plate and calculation

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Blind adolescents aged 13 to 17 years will be assessed under three foot conditions—barefoot, minimalist footwear, and conventional footwear—with and without a cognitive load (dual-task). The assessment will include measures of the center of pressure displacement and impulse at the initiation of the walking cycle.
Category
Rehabilitation

2

Description
Control group: Sighted adolescents aged 13 to 17 years will be assessed under three foot conditions—barefoot, minimalist footwear, and conventional footwear—with and without a cognitive load (dual-task). The assessment will include measures of the center of pressure displacement and impulse at the initiation of the walking cycle.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Iran University of Medical Sciences ,School of Rehabilitation Science
Full name of responsible person
Zahra Rahimi
Street address
Reza Faraji Alley, Shahabadi St., Piroozi
City
Tehran
Province
Tehran
Postal code
1764685783
Phone
+98 21 3308 9985
Email
Zahra.rahimi670@gmail.com

2

Recruitment center
Name of recruitment center
Sport Sciences Research
Full name of responsible person
Zahra Rahimi
Street address
Reza Faraji Alley, Shahabadi St., Piroozi
City
Tehran
Province
Tehran
Postal code
1764685783
Phone
+98 21 3308 9985
Email
Zahra.rahimi670@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Majid Safa
Street address
5th Floor, Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8862 2703
Email
safa.m@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
Zahra Rahimi
Position
Student
Latest degree
Master
Other areas of specialty/work
Orthosis and Prosthesis
Street address
No. 19, 4th Floor, Reza Faraji Alley, Shahabadi Street, Piroozi Street, Tehran, Tehran Province, Iran
City
Tehran
Province
Tehran
Postal code
1764685783
Phone
+98 21 3308 9985
Fax
Email
zahra.rahimi670@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sanjari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biomechanics
Street address
School of Rehabilitation Science, Madakaran Alley, Shah Nazari Street, Mirdamad
City
Tehran
Province
Tehran
Postal code
۱۳۴۸۷ ۱۵۴۵۹
Phone
009822222095
Email
sanjarima@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Zahra Rahimi
Position
Student
Latest degree
Master
Other areas of specialty/work
Orthosis and Prosthesis
Street address
No. 19, 4th Floor, Reza Faraji Alley, Shahabadi Street, Piroozi Street, Tehran, Tehran Province, Iran
City
Tehran
Province
Tehran
Postal code
1764685783
Phone
+98 21 3308 9985
Fax
Email
zahra.rahimi670@gmail.com

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
We do not have ethical approval for this purpose.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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