]>
IRCT20240213060998N3 IRCT 2026-01-02 Tabriz University of Medical Sciences The impact of remote dynamic neuromuscular stabilization exercises on fatigue in individuals with progressive multiple sclerosis The impact of remote dynamic neuromuscular stabilization exercises on fatigue in individuals with progressive multiple sclerosis 2026-01-21 anticipated 28 Complete https://irct.ir/trial/88249 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Health service research. N/A MS, Multiple Sclerosis. 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.. Yes - There is a plan to make this available What will be shared: 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: Access to data begins three months after publication of study results To whom: The study protocol and final study results will be available to the public after publication. Access to other data is done upon request. Conditions: In order to design other research projects in this field, data will be sent. Where to obtain: 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 How to obtain: 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. Comments:
public Laleh Abadi Marand
Daneshjoo Boulevard, Koodakyar
Tehran Iran (Islamic Republic of) ۱۹۸۵۷۱۳۸۳۴ +98 21 7173 2895 laleh.abadipt@gmail.com University of social welfare and rehabilitation sciences scientific Mahboubollah Gholami
Phase 11 - Arazon Bypass - Kozopars Complex - Block B52
Tehran Iran (Islamic Republic of) 1659356765 +98 77 3422 2349 mahboobgh1380x@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) 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. 30 years 50 years Both 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. G35 Multiple sclerosis Rehabilitation 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. 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 . 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. 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). 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. 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. Tabriz University of Medical Sciences Approved 2025-12-01 Ethics committee of Tabriz University of Medical Sciences 29 Bahman Blvd. Tabriz East Azarbaijan Iran (Islamic Republic of)