Exercise Balance Program for Fall Prevention in Multiple Sclerosis

NCT ID: NCT07331350

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-10
• Study Completion Date: 2026-02-28

Brief 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.

Detailed Description

Falls are a common and clinically significant problem in individuals with Multiple Sclerosis (MS), primarily associated with impairments in balance, mobility, muscle strength, and neuromuscular coordination. Exercise-based interventions focusing on balance and functional mobility constitute a core component of fall-prevention strategies; however, the optimal structure and intensity of such programs for individuals with MS remain under investigation.

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. A total of 30 adults with a confirmed diagnosis of MS will be randomly allocated to either an intervention group or a control group using a parallel-group design.

Both groups will participate in a 5-week exercise program that includes home-based exercise performed three times per week. The control group will follow the Otago Exercise Program alone, a standardized and widely used balance and lower-limb strengthening program for fall prevention. The intervention group, in addition to performing the home-based Otago Exercise Program, will participate in one supervised exercise session per week. During these supervised sessions, the Otago-based program will be supplemented with additional balance and mobility tasks of progressively increasing difficulty, designed to challenge static and dynamic postural control, enhance neuromuscular coordination, and promote functional movement adaptability.

Outcome assessments will be conducted at baseline and immediately after completion of the intervention period. Balance will be assessed using the Four-Stage Balance Test (FICSIT-4), functional mobility will be evaluated with the Timed Up and Go test, fear of falling will be measured using the Falls Efficacy Scale-International (FES-I), and perceived walking limitations will be assessed using the 12-item Multiple Sclerosis Walking Scale (MSWS-12).

It is expected that participants in both groups will demonstrate improvements in balance and functional mobility following the intervention period, reflecting the effects of structured balance and strengthening exercises. It is further hypothesized that participants in the intervention group will exhibit greater improvements in balance performance and functional mobility compared with those in the control group, due to the addition of supervised balance and mobility tasks with increased task complexity. Reductions in fear of falling and perceived walking limitations are also anticipated, although these changes may be less pronounced than improvements observed in performance-based outcome measures.

The findings of this study are expected to contribute to a better understanding of exercise-based fall-prevention strategies for individuals with MS and to inform the design of targeted rehabilitation programs aimed at improving balance and mobility in this population.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Otago-Based Balance Program With Additional Balance and Mobility Tasks

Participants assigned to this arm will follow an Otago-based exercise program supplemented with additional balance and mobility tasks.

Group Type: EXPERIMENTAL

Otago-Based Balance Program With Additional Balance and Mobility Tasks

Intervention Type: OTHER

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

Otago Exercise Program

Participants assigned to this arm will follow the Otago Exercise Program alone

Group Type: ACTIVE_COMPARATOR

Otago Exercise Program only

Intervention Type: OTHER

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.

Interventions

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

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Confirmed diagnosis of Multiple Sclerosis.
• Ability to ambulate with or without an assistive device.
• Ability to understand and follow exercise instructions.
• Written informed consent prior to participation.

Exclusion Criteria

• Presence of other neurological, musculoskeletal, or medical conditions that could significantly affect balance or mobility.
• Acute relapse of Multiple Sclerosis at the time of enrollment.
• Participation in another structured balance or fall-prevention program during the study period.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

International Hellenic University

OTHER

Sponsor Role: lead

Responsible Party

Dimitrios Lytras

Assistant Professor of Physiotherapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dimitrios Lytras, PhD

Role: PRINCIPAL_INVESTIGATOR

International Hellenic University

Locations

International Hellenic University

Thessaloniki, , Greece

Countries

Greece

Other Identifiers

EC-17/2025

Identifier Type: -

Identifier Source: org_study_id