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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Balance Performance (FICSIT-4)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Balance Performance (FICSIT-4)
时间窗: Baseline and immediately after completion of the 5-week intervention
Static balance will be assessed using the FICSIT-4 (Four-Stage Balance Test). Participants will attempt to maintain four progressively challenging standing positions (feet together, semi-tandem, tandem, and single-leg stance) for up to 10 seconds each, with eyes open and without an assistive device. The outcome will be recorded as the highest stage successfully held for 10 seconds (range: 0-4), with higher values indicating better balance performance.
Functional Mobility (Timed Up and Go Test)
时间窗: Baseline and immediately after completion of the 5-week intervention
Functional mobility will be assessed using the Timed Up and Go (TUG) test. Participants will be 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 will be recorded in seconds. Shorter completion times indicate better functional mobility.
Fear of Falling (Falls Efficacy Scale-International)
时间窗: Baseline and immediately after completion of the 5-week intervention
Fear of falling will be 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 is scored on a 4-point Likert scale, with total scores ranging from 16 to 64. Higher scores indicate greater concern about falling.
Walking Limitations (12-item Multiple Sclerosis Walking Scale)
时间窗: Baseline and immediately after completion of the 5-week intervention
Perceived walking limitations will be 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 are scored on a Likert scale and transformed to a total score ranging from 0 to 100, with higher scores indicating greater walking impairment.
次要结局
未报告次要终点
研究者
Dimitrios Lytras
Assistant Professor of Physiotherapy
International Hellenic University