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Completed

NCT Number: NCT07331350

Exercise Balance Program for Fall Prevention in Multiple Sclerosis

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

International Hellenic University

Thessaloniki, Greece

About this study

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

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

Both groups received fall-prevention counselling and performed home-based Otago-related exercises three times per week. The active control group followed the home-based Otago-related exercise program supported by instructional video material, without supervised sessions or additional task-oriented balance-training activities. The intervention group, in addition to performing the same home-based Otago-related exercises, participated in one supervised physiotherapy session per week. During these supervised sessions, participants performed progressively challenging colored-circle and Twister-inspired task-oriented balance exercises designed to challenge static and dynamic postural control, enhance neuromuscular coordination, promote visuomotor integration, improve reaction speed, and support adaptability to changing motor demands.

Outcome assessments were conducted at baseline and immediately after completion of the 6-week intervention period. Static balance was assessed using the FICSIT-4, functional mobility was evaluated with the Timed Up and Go test, fear of falling was measured using the Falls Efficacy Scale-International (FES-I), and perceived walking ability was assessed using the 12-item Multiple Sclerosis Walking Scale (MSWS-12).

This study was designed to contribute to a better understanding of exercise-based fall-prevention strategies for individuals with MS and to inform the development of targeted rehabilitation programs aimed at improving balance and mobility in this population.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Balance Performance (FICSIT-4)

    Time frame: Baseline and immediately after completion of the 6-week intervention

    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.

Secondary outcomes

  1. Functional Mobility (Timed Up and Go Test)

    Time frame: Baseline and immediately after completion of the 6-week intervention

    Functional mobility was assessed using the Timed Up and Go (TUG) test. Participants were instructed to stand up from a standard chair, walk a distance of 3 meters, turn around, walk back to the chair, and sit down at a comfortable and safe pace. The time required to complete the task was recorded in seconds. Shorter completion times indicated better functional mobility.

  2. Fear of Falling (Falls Efficacy Scale-International)

    Time frame: Baseline and immediately after completion of the 6-week intervention

    Fear of falling was assessed using the Falls Efficacy Scale-International (FES-I), a validated self-reported questionnaire consisting of 16 items that assess concern about falling during a range of daily activities. Each item was scored on a 4-point Likert scale, with total scores ranging from 16 to 64. Higher scores indicated greater concern about falling.

  3. Walking Limitations (12-item Multiple Sclerosis Walking Scale)

    Time frame: Baseline and immediately after completion of the 6-week intervention

    Perceived walking limitations were assessed using the 12-item Multiple Sclerosis Walking Scale (MSWS-12), a disease-specific, self-reported questionnaire that evaluates the impact of multiple sclerosis on walking ability. Items were scored on a Likert scale and transformed to a total score ranging from 0 to 100, with higher scores indicating greater walking impairment.

Sponsors and collaborators

Lead sponsor

International Hellenic University

Other

Registry information

Official study title

Effects of an Otago-Based Exercise and Game-Inspired Balance Training Program on Balance, Mobility, and Fall-Related Outcomes in Individuals With Multiple Sclerosis: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 9, 2026
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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