Exercise Balance Program for Fall Prevention in Multiple Sclerosis
NCT07331350 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2026-01-21
Summary
Falls are a major concern for individuals with Multiple Sclerosis (MS), negatively affecting balance, mobility, independence, and quality of life, while increasing the risk of injury. This randomized controlled trial aims to investigate the effects of a 5-week exercise-based balance program on fall-related outcomes in individuals with MS. Thirty participants with MS will be randomly allocated to either an intervention group or a control group. The intervention group will follow an Otago-based exercise program supplemented with additional balance and mobility tasks, while the control group will follow the Otago Exercise Program alone. Participants in both groups will perform home-based exercises three times per week. Outcomes will be assessed before and after the intervention period using the FICSIT-4 for balance, the Timed Up and Go test for mobility, the Falls Efficacy Scale-International (FES-I) for fear of falling, and the 12-item Multiple Sclerosis Walking Scale (MSWS-12) for walking limitations.
Conditions
Interventions
- OTHER
-
Otago-Based Balance Program With Additional Balance and Mobility Tasks
Participants assigned to the intervention group followed a 5-week exercise-based balance program consisting of one supervised session per week combined with home-based exercises performed three times per week. The program was based on the Otago Exercise Program and was supplemented during supervised sessions with progressively challenging balance, mobility, and visuomotor tasks incorporating cognitive demands. Exercises included multidirectional stepping, lateral weight shifting, sit-to-stand movements, sideways walking, and heel-to-toe standing, with progression achieved through increased task complexity, speed, and duration. Additional task-oriented activities required participants to respond to verbal cues using colored floor markers to perform specific foot placements and postural tasks, with weekly variation in task-color associations to enhance cognitive engagement. A final multidirectional stepping task emphasized rapid changes in direction and movement speed, aiming to improve
- OTHER
-
Otago Exercise Program only
Participants assigned to the control group followed the Otago Exercise Program alone for a total duration of 5 weeks. The program consisted of standardized balance and lower-limb strengthening exercises designed for fall prevention and was performed exclusively as a home-based program three times per week. Exercises included multidirectional stepping, lateral weight shifting, sit-to-stand movements, sideways walking, and heel-to-toe standing, with progression achieved through adjustments in repetitions and sets. No supervised exercise sessions or additional balance, mobility, or cognitive tasks were provided to the control group during the intervention period.
Sponsors & Collaborators
-
International Hellenic University
lead OTHER
Principal Investigators
-
Dimitrios Lytras, PhD · International Hellenic University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 64 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-01-10
- Primary Completion
- 2026-02-28
- Completion
- 2026-02-28
Countries
- Greece
Study Locations
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