Exercise Balance Program for Fall Prevention in Multiple Sclerosis

NCT07331350 | Completed

• 1 other identifier: EC-1/2026
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Falls and balance impairments are common in individuals with multiple sclerosis (MS) and may negatively affect mobility, independence, confidence in daily activities, and quality of life, while increasing the risk of injury. This randomized controlled trial investigated the effects of a 6-week combined Otago-based and game-inspired balance-training program on static balance, functional mobility, fear of falling, and perceived walking ability in individuals with MS. Thirty participants with MS were randomly allocated to either an intervention group or an active control group. Both groups received fall-prevention counselling and performed home-based Otago-related exercises three times per week. The intervention group additionally received one supervised balance-training session per week using colored-circle and Twister-inspired task-oriented exercises. Outcomes were assessed at baseline and immediately after the intervention period using the FICSIT-4 for static balance, the Timed Up and Go test for functional mobility, the Falls Efficacy Scale-International (FES-I) for fear of falling, and the 12-item Multiple Sclerosis Walking Scale (MSWS-12) for perceived walking limitations.

Conditions

Multiple Sclerosis

Keywords

Accidental Falls; Balance Impairment; Physiotherapy

Outcome Measures

Primary Outcomes (1)

• Balance Performance (FICSIT-4)

  Static balance was assessed using the FICSIT-4. Participants attempted to maintain progressively challenging standing positions, including feet together, semi-tandem stance, tandem stance, and single-leg stance, for up to 10 seconds each. The outcome was recorded as a total score, with higher values indicating better static balance.

  Baseline and immediately after completion of the 6-week intervention

Secondary Outcomes (3)

• Functional Mobility (Timed Up and Go Test)

  Baseline and immediately after completion of the 6-week intervention

• Fear of Falling (Falls Efficacy Scale-International)

  Baseline and immediately after completion of the 6-week intervention

• Walking Limitations (12-item Multiple Sclerosis Walking Scale)

  Baseline and immediately after completion of the 6-week intervention

Study Arms (2)

Combined Otago-Based and Game-Inspired Balance Training

EXPERIMENTAL

Participants in the intervention group received fall-prevention counselling and performed home-based Otago-related exercises three times per week for 6 weeks. In addition, they attended one supervised physiotherapy session per week, during which they performed colored-circle and Twister-inspired task-oriented balance exercises.

Other: Combined Otago-Based and Game-Inspired Balance Training

Home-Based Otago-Related Exercises and Fall-Prevention Counselling

ACTIVE COMPARATOR

This intervention consisted of selected Otago-related balance and lower-limb strengthening exercises performed at home three times per week for 6 weeks. Participants also received fall-prevention counselling and instructional material for home practice. No supervised colored-marker or Twister-inspired balance tasks were included.

Other: Otago Exercise Program only

Interventions

Otago Exercise Program only OTHER

This intervention consisted of selected Otago-related balance and lower-limb strengthening exercises performed at home three times per week for 6 weeks. Participants also received fall-prevention counselling and instructional material for home practice. No supervised colored-marker or Twister-inspired balance tasks were included.

Home-Based Otago-Related Exercises and Fall-Prevention Counselling

Combined Otago-Based and Game-Inspired Balance Training OTHER

This intervention combined home-based Otago-related exercises with supervised task-oriented balance training. The home-based component included selected balance and lower-limb strengthening exercises performed three times per week. The supervised component was delivered once weekly and included exercises with colored floor markers, postural tasks linked to color cues, and Twister-inspired stepping activities. These tasks were used to challenge postural control, coordination, visuomotor responses, and movement adaptability.

Combined Otago-Based and Game-Inspired Balance Training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of multiple sclerosis according to the 2010 McDonald criteria.
• Age between 18 and 65 years.
• Ability to ambulate independently with or without an assistive device.
• Ability to understand and follow exercise instructions.
• Written informed consent prior to participation.

You may not qualify if:

• 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.

Sponsors & Collaborators

• International Hellenic University: lead

Study Sites (1)

International Hellenic University

Thessaloniki, Greece

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Dimitrios Lytras, PhD

  International Hellenic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessments were performed by an independent assessor who was blinded to group allocation. Participants were randomly assigned to either an intervention group or an active control group and followed their respective exercise programs in parallel over the 6-week intervention period.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Physiotherapy

Study Record Dates

• First Submitted: December 28, 2025
• First Posted: January 9, 2026
• Study Start: February 1, 2026
• Primary Completion: May 10, 2026
• Study Completion: May 10, 2026
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)