Investigating effects of mental fatigue on cognitive-motor interference during walking in people with multiple sclerosis and healthy
Design
A randomized, controlled, double-blind, parallel-group study with a pretest–posttest design in 30 healthy and 30 individuals with MS. Computer-generated block randomization will be used.
Settings and conduct
This study will be conducted at the Rehabilitation Research Center located in the Faculty of Rehabilitation Sciences, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. After the healthy and MS participants were classified into two fatigue and control groups, walking performance will be assessed on a treadmill at a preferred speed in the single walking and walking with concurrent consecutive subtraction of 7 numbers from a randomly selected number. Gait assessment will be performed using Vicon.Gait assessment will be conducted before and after fatigue induction and watching the documentary film. This study is double-blind and participants and outcome assessor will not be aware of type of grouping (mental fatigue induction or control).
Participants/Inclusion and exclusion criteria
Inclusion criteria: MMSE score >24, EDSS score <6
Exclusion criteria: Recurrence of the disease in the past 1 month, Visual involvement
Intervention groups
Participants in healthy and MS group will be randomly assigned to two groups of mental fatigue and control.
Mental fatigue protocol: In this study, mental fatigue will be induced using a modified version of 100% incongruent visual Stroop task(color-word).
Control: In this condition, participants will choose their favorite film from 3 suggested documentaries.
Main outcome variables
Dual task cost of double support phase; step width; cadence; stride length; stride time; swing phase; dual task cost of the coefficient of variation for double support phase; step width; stride length; stride time; swing phase
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240111060675N2
Registration date:2026-10-18, 1405/07/26
Registration timing:prospective
Last update:2026-10-18, 1405/07/26
Update count:0
Registration date
2026-10-18, 1405/07/26
Registrant information
Name
Razieh Mofateh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3101
Email address
mofatehr@yahoo.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-10-19, 1405/07/27
Expected recruitment end date
2026-12-26, 1405/10/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effects of mental fatigue on cognitive-motor interference during walking in people with multiple sclerosis and healthy
Public title
Investigating the effects of mental fatigue on cognitive-motor interference during walking in people with multiple sclerosis and healthy
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmation of multiple sclerosis by a neurologist
Ability to read and write in Persian
Avoid alcohol, nicotine, and caffeinated beverages 24 hours before the study.
MMSE Score > 24
Expanded Disability Status Scale (EDSS) > 6
Ability to walk without resting using an assistive device for 3 minutes
No balance and gait disorders in healthy individuals
Exclusion criteria:
Recurrence of the disease in the past 1 month
Visual involvement
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible participants in each group of healthy and MS will be assigned 1:1 to either the mental fatigue or control groups using a computerized block randomization method. Randomization will be performed using alternating blocks of variable size to maintain balanced allocation. The randomization sequence will be performed by an independent investigator who is not involved in the current research project. The groups will then be concealed by opaque envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double-blind. As such, the participants and outcome assessors will not be aware of the type of grouping (mental fatigue group or control group) in people with MS and healthy
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan street, Department of Physiotherapy, School of Rehabilitation Sciences, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-33133
Approval date
2024-11-02, 1403/08/12
Ethics committee reference number
IR.AJUMS.REC.1403.423
Health conditions studied
1
Description of health condition studied
MS
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Dual task cost of gait variables
Timepoint
Before and after mental fatigue induction and watching a documentary film
Method of measurement
The dual task cost is the mean of the stance phase variables, stride width, cadence, stride length, stride time, and swing phase, and the dual task cost is the coefficient of variance of the stance phase variables, stride width, stride length, stride time, and swing phase. The dual task cost is calculated by subtracting the value of the variable in the dual task condition from its value in the single task condition, divided by its value in the single task condition, multiplied by 100.
Secondary outcomes
1
Description
Dual task cost of cognitive performance
Timepoint
Before and after inducing mental fatigue and watching a documentary film
Method of measurement
DDual task cost for cognitive task performance (percentage of correct responses) was calculated by subtracting the percentage of correct responses in the dual task condition from its value in the sitting condition divided by its value in the sitting condition multiplied by 100.
Intervention groups
1
Description
Intervention group: mental fatigue protocol: In this study, mental fatigue will be induced using a modified version of the 100% incongruent visual Stroop task (color-word).
Category
Rehabilitation
2
Description
Control group: In this group, participants will choose their favorite film from the 3 suggested documentaries.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Rehabilitation Research Center located in the Faculty of Rehabilitation Sciences, Ahvaz Jundishapur
Full name of responsible person
Razieh Mofateh
Street address
Department of Physiotherapy, School of Rehabilitation Sciences, Ahvaz Jundishapur University of Medical Sciences, Golestan Street, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-33133
Phone
+98 21 3374 3101
Email
mofatehr@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Abdullah Rafiei
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan street, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3373 8383
Email
rafiei-a@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Razieh Mofateh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Department of Physiotherapy, School of Rehabilitation Sciences, Ahvaz Jundishapur University of Medical Sciences, Golestan Street, Ahvaz, Iran.
City
Ahvaz
Province
Khouzestan
Postal code
61357-33133
Phone
0098 61 333743101
Email
mofatehr@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Razieh Mofateh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Department of Physiotherapy, School of Rehabilitation Sciences, Ahvaz Jundishapur University of Medical Sciences, Golestan Street, Ahvaz, Iran.
City
Ahvaz
Province
Khouzestan
Postal code
61357-33133
Phone
+98 61 3374 3101
Email
mofatehr@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Razieh Mofateh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Department of Physiotherapy, School of Rehabilitation Sciences, Ahvaz Jundishapur University of Medical Sciences, Golestan Street, Ahvaz, Iran.
City
Ahvaz
Province
Khouzestan
Postal code
61357-33133
Phone
0098 61 333743101
Email
mofatehr@yahoo.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
According to the research team's decision, there are no plans to publish it.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Most data is shareable.
When the data will become available and for how long
Access period begins after results are published.
To whom data/document is available
The data will be available to physiotherapist
Under which criteria data/document could be used
Researchers and physiotherapists
From where data/document is obtainable
Applications can contact the following email for more information: mofatehr@yahoo.com
What processes are involved for a request to access data/document
After authentication and if approved by the people participating in the study, the individual can receive the information.