MS, Multiple Sclerosis. Multiple sclerosis
Conditions
Interventions
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 th
Sponsors
Tabriz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
30 Years to 50 Years
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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, | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactLaleh Abadi Marand
University of social welfare and rehabilitation sciences
Outcome results
None listed