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The impact of remote dynamic neuromuscular stabilization exercises on fatigue in individuals with progressive multiple sclerosis

Protocol summary

Study aim
To investigate the effect of a dynamic neuromuscular stabilization exercise program supervised via telerehabilitation on the quality of life, fatigue, mobility level, and spasticity in patients with multiple sclerosis.
Design
This study will be a single-arm with a pre-test and post-test. Due to the nature of the exercise-based telerehabilitation intervention, blinding of participants and therapist is not feasible. however, outcome assessment will be conduct by an independent assessor who is blinded to the intervention details to minimize assessment bias. All participants will undergo the same exercise intervention supervised via remote rehabilitation. Due to the absence of a control group, randomization will not be necessary.
Settings and conduct
All participants will undergo the same exercise intervention supervised via remote rehabilitation. Due to the absence of a control group, randomization will not be necessary.
Participants/Inclusion and exclusion criteria
Men and women with Multiple Sclerosis and moderate disability, diagnosed within the specified time frame, will be selected for this study. All participants will undergo a comprehensive neurological examination by a specialist to determine their level of disability, disease course, medical history, and current medications.
Intervention groups
Men and women with Multiple Sclerosis and moderate disability, diagnosed within the specified time frame, will be selected for this study. All participants will undergo a comprehensive neurological examination by a specialist to determine their level of disability, disease course, medical history, and current medications.
Main outcome variables
Fatigue

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240213060998N3
Registration date: 2026-01-02, 1404/10/12
Registration timing: prospective

Last update: 2026-01-02, 1404/10/12
Update count: 0
Registration date
2026-01-02, 1404/10/12
Registrant information
Name
Zahra Salahzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3327 1531
Email address
zsalahzadeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-01-21, 1404/11/01
Expected recruitment end date
2026-05-21, 1405/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of remote dynamic neuromuscular stabilization exercises on fatigue in individuals with progressive multiple sclerosis
Public title
The impact of remote dynamic neuromuscular stabilization exercises on fatigue in individuals with progressive multiple sclerosis
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 30 and 50 years Moderate disability with an EDSS score between 4 and 7 A minimum score of 21 on the Mini-Mental State Examination (MMSE) Willingness to participate and signing of the informed consent form Minimum education level of high school diploma Absence of other neurological disorder diagnoses No MS relapse in the past month Absence of apraxia Absence of ataxia caused by motor coordination disorder No history of surgery on the lower limbs Absence of severe postural abnormalities in the spine or lower limbs Absence of cardiovascular diseases Absence of uncontrolled diabetes Patients who have received regular physiotherapy or occupational therapy in the past 3 months will be excluded from the study to allow for an independent evaluation of the current intervention's effect. Individuals who occasionally use rehabilitation services (e.g., less than one session per month) are permitted to participate if they adhere to the study protocol. Presence of spasticity of grade 1 or higher based on the Modified Ashworth Scale.
Exclusion criteria:
Desire to withdraw from the study Failure to complete the intervention or occurrence of an incident affecting balance Pregnancy Starting any new physiotherapy or occupational therapy program during the intervention period Change in the dosage of anti-spasticity medications (as per the neurologist's opinion) during the study.
Age
From 30 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 28
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
29 Bahman Blvd.
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Approval date
2025-12-01, 1404/09/10
Ethics committee reference number
IR.TBZMED.REC.1404.665

Health conditions studied

1

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

Primary outcomes

1

Description
Fatigue based on MFIS questionnaire
Timepoint
Pre-intervention (Pre-test): One day before starting the exercise program.- Post-intervention (Post-test): One day after the end of the tenth week.- Follow-up: 3 months after the end of the intervention (to assess the sustainability of effects).
Method of measurement
this outcome will be assessed using the Modified Fatigue Impact Scale (MFIS).This 21-item questionnaire evaluates fatigue in three domains: cognitive, physical, and psychosocial. Its validity and reliability have been confirmed in numerous studies (Cronbach's alpha 0.8). Patients will complete the questionnaire online (via Google Forms or a filled-out PDF) or during video sessions (Google Meet) under the assessor's supervision. Physical presence is not required, and the location of implementation will be the patients' homes with internet access .

Secondary outcomes

1

Description
Health-Related Quality of Life
Timepoint
The initial assessment will be conducted one day before starting the treatment, and the final assessment will be conducted one day after receiving the last treatment session. Due to the lack of in-person access for participants, all questionnaires will be provided in a single PDF file and will be filled out under the supervision of an assessor. To evaluate the sustainability of the treatment effects, another assessment will be conducted three months after the second assessment
Method of measurement
Since MS is a chronic disease, improving quality of life is a primary goal of rehabilitation interventions. To measure this variable, the Multiple Sclerosis Quality of Life-54 (MSQoL-54) questionnaire will be used. This questionnaire consists of 54 items across two sections: physical health and mental health. Its content and construct validity have been confirmed in MS patients (Cronbach's alpha 0.89-0.95). It will be administered electronically via PDF, and the location will be the patients' homes

2

Description
Mobility
Timepoint
The initial assessment will be conducted one day before starting the treatment, and the final assessment will be conducted one day after receiving the last treatment session. Due to the lack of in-person access for participants, all questionnaires will be provided in a single PDF file and will be filled out under the supervision of an assessor. To evaluate the sustainability of the treatment effects, another assessment will be conducted three months after the second assessment
Method of measurement
Gait and mobility impairments are common problems in MS patients. The Multiple Sclerosis Walking Scale-12 (MSWS-12) has been selected as a valid tool to assess this outcome. This 12-item questionnaire focuses on walking limitations. Its reliability has been reported with a Cronbach's alpha of 0.94. Patients will record their responses during video calls or by filling out the online form. For objective assessment, patients may be asked to video record their walking. The location will be a safe space in the patient's home (such as a hallway or empty room)

3

Description
Balance
Timepoint
The initial assessment will be conducted one day before starting the treatment, and the final assessment will be conducted one day after receiving the last treatment session. Due to the lack of in-person access for participants, all questionnaires will be provided in a single PDF file and will be filled out under the supervision of an assessor. To evaluate the sustainability of the treatment effects, another assessment will be conducted three months after the second assessment
Method of measurement
To assess this outcome, the Activities-specific Balance Confidence Scale (ABC) will be used. This is a 16-item questionnaire with high reliability (Cronbach's alpha 0.96) and good validity for MS patients. It will be conducted online or during video sessions with the assessor's guidance, in the patient's home

4

Description
Spasticity
Timepoint
The initial assessment will be conducted one day before starting the treatment, and the final assessment will be conducted one day after receiving the last treatment session. Due to the lack of in-person access for participants, all questionnaires will be provided in a single PDF file and will be filled out under the supervision of an assessor. To evaluate the sustainability of the treatment effects, another assessment will be conducted three months after the second assessment
Method of measurement
this outcome will be assessed using the Multiple Sclerosis Spasticity Scale-88 (MSSS-88). Patients without spasticity will score low in this section, which helps in data differentiation. This 88-item questionnaire has confirmed validity and reliability (Cronbach's alpha 0.92-0.95). It will be conducted online or during video sessions with the assessor's guidance, in the patient's home

Intervention groups

1

Description
Intervention group: At the beginning of the study, participants and their caregivers will receive comprehensive education about the importance of physical therapy exercises for the participants and the necessity of maintaining long-term adherence. This educational session will be held via Google Meet to ensure greater accessibility and interaction. Additionally, participants or their caregivers will be taught how to modify their home environment to reduce the risk of falls.Participants will carry out a 10-week home-based physical therapy exercise program, consisting of two sessions per week. The duration of each session will be determined and recorded based on the severity of the participants' symptoms and individual abilities. The intensity of the exercises and rest periods will be adjusted to each participant's condition to ensure optimal safety and effectiveness. All sessions will be held in the morning, and participants will be advised to empty their bladder before starting each session.All exercises will be performed on a mat or chair. To ensure a suitable environment for exercise, participants will be encouraged to choose a cool, quiet, and distraction-free space in their homes. Rest periods at pre-determined intervals based on individual needs will be included to prevent excessive fatigue. The program will follow a progressive structure.A physiotherapist with five years of experience in neurological rehabilitation will remotely supervise the physical therapy exercise program. Supervision and guidance will be conducted via Google Meet video calls, allowing for direct monitoring, feedback, and progress assessment. The physiotherapist will adjust the intensity and duration of the exercises based on each participant's physical capacity and will carefully monitor their physical and emotional state.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
MS TAVANMAND Charity
Full name of responsible person
Laleh abadi
Street address
Second Floor, Unit 37, 8th Alley (North), Mofateh Street (North), Shahid Beheshti Street
City
Tehran
Province
Tehran
Postal code
۱۵۸۷۸۱۵۱۳۳
Phone
+98 21 8873 8024
Fax
+98 21 8873 8026
Email
info@ms-tavan.ir
Web page address
https://ms-tavan.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Khosro Adibkia
Street address
Faculty of Rehabilitation Sciences, University of Medical Sciences, 29 Bahman Blvd, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3337 2072
Email
rehab.fac@tbzedmed.ac.ir
Web page address
https://rehabilitation.tbzmed.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
University of social welfare and rehabilitation sciences
Full name of responsible person
Laleh Abadi Marand
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Daneshjoo Boulevard, Koodakyar
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۳۸۳۴
Phone
+98 21 7173 2895
Email
laleh.abadipt@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mahboubollah Gholami
Position
Doctor of Physiotherapy student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Phase 11 - Arazon Bypass - Kozopars Complex - Block B52
City
Tehran
Province
Tehran
Postal code
1659356765
Phone
+98 77 3422 2349
Email
mahboobgh1380x@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Zahra Salahzadeh
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of rehabilitation sciences, Tabriz University of medical sciences, 29 Bahman Str, Tabriz Univerisity
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3327 1531
Email
zsalahzadeh@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
1. The data file of the participants will be designed and collected without mentioning the name and with ID definition. 2. The study protocol will be published in the form of an article after the start of data collection. 3. The statistical analysis map will be prepared in SPSS file format after data collection. 4. The informed consent form of this study was designed and will be available to the participants. 5. The clinical study report will be prepared and published in the form of six-month reports and the final report.
When the data will become available and for how long
Access to data begins three months after publication of study results
To whom data/document is available
The study protocol and final study results will be available to the public after publication. Access to other data is done upon request.
Under which criteria data/document could be used
In order to design other research projects in this field, data will be sent.
From where data/document is obtainable
To receive the data and documents of this study, the scientific officer of this project can be contacted via e-mail. email address: mahboobgh1380@gmail.com
What processes are involved for a request to access data/document
After sending and reviewing the request for access to the data, in accordance with the principle of confidentiality of the personal information of the study participants, the data will be sent within a few days to a few weeks.
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