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Effects of backward walking on balance, gait, functional and muscle activity in women with multiple sclerosis

Protocol summary

Study aim
Investigating the effects of backward walking on balance, gait, function, and muscle activity in women with multiple sclerosis
Design
The current research is semi-experimental and practical and has pre-test and post-test. It has an intervention group and a control group, with parallel and unblinded groups. The statistical population will include women with MS in Arak city. Using G*power software, 30 people were selected in a purposeful and accessible manner, and then they will be randomly divided into two experimental groups (15 people) and control (15 people).
Settings and conduct
After completing the consent form, the pre-test including timed up and go test, dynamic gait index test, 25-foot walk test, Berg test, electromyography test is performed in the laboratory of Arak University. After 8 weeks of training, the post-test will be repeated with the same assessments. Trainings are held in the gymnasium of Arak University.
Participants/Inclusion and exclusion criteria
Participants: Women with multiple sclerosis in Arak Inclusion: Age 25-45, EDSS score 3-6, no cardiovascular, neurological, or orthopedic conditions Exclusion: Withdrawal from study, injury during research
Intervention groups
Experimental Group: Backward walking training for 8 weeks, 3 sessions per week, including moderate-intensity backward walking with rest intervals. Control Group: Forward walking training with the same frequency, intensity, and duration, without backward walking exercises
Main outcome variables
Balance; Gait speed; Motor performance; Muscle activity

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250206064672N1
Registration date: 2025-03-24, 1404/01/04
Registration timing: prospective

Last update: 2025-03-24, 1404/01/04
Update count: 0
Registration date
2025-03-24, 1404/01/04
Registrant information
Name
Faezeh Moradi
Name of organization / entity
Arak University
Country
Iran (Islamic Republic of)
Phone
+98 38 3426 3814
Email address
f.moradi.02@msc.araku.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-04-14, 1404/01/25
Expected recruitment end date
2025-07-11, 1404/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of backward walking on balance, gait, functional and muscle activity in women with multiple sclerosis
Public title
Effects of backward walking on balance, gait, functional and muscle activity in women with multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with multiple sclerosis between the ages of 25-45 Expanded Disability Status Scale (EDSS) score between -3 and 6 Absence of any cardiovascular, neurological, orthopedic diseases, ear problems, etc.
Exclusion criteria:
If for any reason they are not willing to continue participating in the research and suffer an injury during the research that prevents them from continuing.
Age
From 25 years old to 50 years old
Gender
Female
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Arak University Ethics Committee
Street address
Arak University, Karbala Blvd, Basij Sq, Arak, Iran
City
Arak
Province
Markazi
Postal code
۳۸۴۸۱۷۷۵۸۴
Approval date
2025-01-08, 1403/10/19
Ethics committee reference number
IR.ARAKU.REC.1403.060

Health conditions studied

1

Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
G35

Primary outcomes

1

Description
Balance: The patient’s balance score is assessed using the Berg Balance Scale. This scale consists of 14 items that evaluate the patient’s ability to maintain balance in different positions.
Timepoint
At the beginning of the study and after 8 weeks of training
Method of measurement
Berg Balance Scale

2

Description
Gait
Timepoint
At the beginning of the study and after 8 weeks of training
Method of measurement
25-foot walk test

3

Description
Functional Activity
Timepoint
At the beginning of the study and after 8 weeks of training
Method of measurement
Dynamic Gait Index (DGI)

4

Description
Electromyography - EMG
Timepoint
At the beginning of the study and after 8 weeks of training
Method of measurement
Recording electrical signals from calf and thigh muscles during walking using EMG

Secondary outcomes

empty

Intervention groups

1

Description
"Intervention group:" Participants in this group will perform forward and backward walking exercises for 8 weeks, 3 sessions per week. Each session will consist of normal walking, followed by 10 minutes of rest, and then moderate-intensity backward walking exercises (14-15 on the Borg scale). The number of repetitions will vary from 3 to 10 times, with 1 to 2 minutes of rest between repetitions. The exercises will be performed under the supervision of researchers in the gymnasium of Arak University.
Category
Rehabilitation

2

Description
Control group: The participants of this group perform forward walking exercise for 8 weeks, 3 sessions per week. Each session consists of normal walking of moderate intensity (14-15 according to the Borg scale). The number of repetitions varies from 3 to 10 times and 1 to 2 minutes rest is considered between repetitions. Exercises are carried out under the supervision of researchers in the sports hall of Arak University.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Multiple Sclerosis Society
Full name of responsible person
Abbas Amiri
Street address
MS Patients Complex, Next to Yadegar-e-Imam Stadium, Farabi Street, Gerdo Town, Arak, Markazi Province, Iran
City
Arak
Province
Markazi
Postal code
53536-38191
Phone
+98 86 3279 0084
Fax
Email
info@markazi-ms.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University
Full name of responsible person
Mohammad Ali Badaghifard
Street address
Arak University, Karbala Boulevard, Basij Square, Arak, Markazi Province, Iran
City
Arak
Province
Markazi
Postal code
۳۸۴۸۱۷۷۵۸۴
Phone
+98 86 3262 2000
Email
e-dabir@araku.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University
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
Arak University
Full name of responsible person
Faezeh Moradi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Pathology and corrective movements
Street address
Karbala Boulevard, Basij Square
City
Arak
Province
Markazi
Postal code
۳۸۴۸۱۷۷۵۸۴
Phone
+98 86 3262 1042
Email
f.moradi.02@msc.araku.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak Univercity
Full name of responsible person
Faezeh Moradi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Pathology and corrective movements
Street address
Shahid Rajaee Street
City
Broujen
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8875133731
Phone
+98 38 3426 3814
Email
f.moradi02@msc.araku.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Arak Univercity
Full name of responsible person
Faezeh Moradi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Pathology and corrective movements
Street address
Shahid Rajaee Street
City
broujen
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8875133731
Phone
+98 38 3426 3814
Email
f.moradi.02@msc.araku.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
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