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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07331350 on ClinicalTrials.gov