多发性硬化症防跌倒运动平衡计划
运动平衡项目对多发性硬化症患者跌倒预防的效果:一项随机临床试验
研究概览
地位
条件
详细说明
跌倒是多发性硬化症(MS)患者常见且具有临床意义的问题,主要与平衡、活动能力、肌肉力量和神经肌肉协调性受损相关。 基于锻炼的干预措施,侧重于平衡和功能性活动能力,构成了跌倒预防策略的核心组成部分;然而,针对多发性硬化症患者此类项目的最佳结构和强度仍在研究中。
这项随机对照试验旨在研究为期5周的基于锻炼的平衡项目对多发性硬化症患者跌倒相关结果的影响。 共有30名确诊为多发性硬化症的成年人将通过平行组设计被随机分配到干预组或对照组。
两组都将参加为期5周的锻炼项目,包括每周三次的家庭锻炼。 对照组将仅遵循奥塔戈锻炼项目,这是一种标准化且广泛使用的预防跌倒的平衡和下肢强化项目。 干预组除了执行家庭奥塔戈锻炼项目外,每周还将参加一次有监督的锻炼课程。 在这些有监督的课程中,奥塔戈项目将补充额外的平衡和活动能力任务,难度逐渐增加,旨在挑战静态和动态姿势控制、增强神经肌肉协调性并促进功能性运动的适应性。
结果评估将在基线和干预期结束后立即进行。 平衡将使用四阶段平衡测试(FICSIT-4)评估,功能性活动能力将通过计时起立行走测试评估,对跌倒的恐惧将使用国际跌倒效能量表(FES-I)测量,感知行走限制将使用12项多发性硬化症行走量表(MSWS-12)评估。
预计两组参与者在干预期后均会在平衡和功能性活动能力方面表现出改善,反映了结构化平衡和强化锻炼的效果。 进一步假设,由于增加了任务复杂性更高的有监督平衡和活动能力任务,干预组参与者将在平衡表现和功能性活动能力方面比对照组参与者表现出更大的改善。 对跌倒的恐惧和感知行走限制的减少也有望实现,尽管这些变化可能不如基于表现的结果指标中观察到的改善明显。
本研究的结果预计将有助于更好地理解针对多发性硬化症患者的基于锻炼的跌倒预防策略,并为旨在改善该人群平衡和活动能力的针对性康复项目设计提供参考。
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Thessaloniki、希腊
- International Hellenic University
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
纳入标准:
- 确诊为多发性硬化症。
- 能够借助或不借助辅助设备行走。
- 能够理解并遵循锻炼指导。
- 参与前签署书面知情同意书。
排除标准:
- 存在其他可能显著影响平衡或活动能力的神经、肌肉骨骼或内科疾病。
- 入组时多发性硬化症处于急性复发期。
- 研究期间参与其他结构化平衡或防跌倒项目。
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Combined Otago-Based and Game-Inspired Balance Training
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.
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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.
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有源比较器:Home-Based Otago-Related Exercises and Fall-Prevention Counselling
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.
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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.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Balance Performance (FICSIT-4)
大体时间:Baseline and immediately after completion of the 6-week intervention
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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.
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Baseline and immediately after completion of the 6-week intervention
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Functional Mobility (Timed Up and Go Test)
大体时间:Baseline and immediately after completion of the 6-week intervention
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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.
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Baseline and immediately after completion of the 6-week intervention
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Fear of Falling (Falls Efficacy Scale-International)
大体时间:Baseline and immediately after completion of the 6-week intervention
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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.
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Baseline and immediately after completion of the 6-week intervention
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Walking Limitations (12-item Multiple Sclerosis Walking Scale)
大体时间:Baseline and immediately after completion of the 6-week intervention
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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.
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Baseline and immediately after completion of the 6-week intervention
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合作者和调查者
调查人员
- 首席研究员:Dimitrios Lytras, PhD、International Hellenic University
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- EC-1/2026
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
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