NCT07058870招募中不适用
Unravelling The Optimisation And Consolidation Of Motor Skills In People With Multiple Sclerosis With Mild to Moderate Gait Impairment Via High Intensity Task Oriented Circuit Training: A Feasibility Study
University Hospital of Ferrara1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2024年10月15日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Change in Balance
研究概览
简要总结
The goal of this feasibility study is to test the safety and effectiveness of an high-intensity task oriented circuit training program, followed by three months of telerehabilitation in people with mild to moderate Multiple Sclerosis (MS). The main questions it aims to answer are:
- Can high-intensity task oriented circuit training improve gait and balance functional capacity?
- Can telerehabilitation mantain the benefits in gait and balance gained via circuit training for a six month period?
Participants will:
- Complete 10 session ( one hour each, three times a week) of high-intensity task oriented circuit training administered in a hospital setting. The training will target key motor skills such as walking, stepping, supine to stand transitions and general mobility.
- Engage in 3 months of asynchronous telerehabilitation (without physiotherapist supervision)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of primary or secondary progressive multiple sclerosis according to the McDonald criteria.
- •Mini-Mental State Examination (MMSE) score >
- •Expanded Disability Status Scale (EDSS) score ≤ 6.
排除标准
- •Presence of other psychiatric or neurological disorders.
- •Cardiopulmonary, renal, or liver diseases.
- •Pregnancy.
- •Modifications in drug treatment within the last 3 months.
研究组 & 干预措施
Experimental: High Intensity Task Oriented Circuit Training + Telerehabilitation
Experimental
Participants will receive 10 sessions (one hour each, three times a week) including structured exercise stations targeting key motor skills such as walking, walking adaptability, stepping and supine to stand transition.
Afterwards, participants will engage in 36 sessions (30 minutes each, three times a week) of asynchronous telerehabilitation targeting supine to stand transition, stepping and walking.
干预措施: High Intensity Task Oriented Circuit Training + Telerehabilitation (Behavioral)
结局指标
主要结局
Change in Balance
时间窗: Baseline testing (T0), score changes after the 4 weeks in-hospital treatment (T1), score changes after the 3-months asynchronous telerehabilitation intervention (T1) and score changes at follow up, 3 months after telerehabilitation intervetion (T3)
The change in balance will be assessed using the Fullerton Advanced Balance Scale
次要结局
- Change in quantitative mobility and leg function performance(Baseline testing (T0), score changes after the 4 weeks in-hospital treatment (T1), score changes after the 3-months asynchronous telerehabilitation intervention (T1) and score changes at follow up, 3 months after telerehabilitation intervetion (T3))
- Change in Walking Speed(Baseline testing (T0), score changes after the 4 weeks in-hospital treatment (T1), score changes after the 3-months asynchronous telerehabilitation intervention (T1) and score changes at follow up, 3 months after telerehabilitation intervetion (T3))
- Change in mobility, balance, walking ability, and fall risk(Baseline testing (T0), score changes after the 4 weeks in-hospital treatment (T1), score changes after the 3-months asynchronous telerehabilitation intervention (T1) and score changes at follow up, 3 months after telerehabilitation intervetion (T3))
- Change in Dual task Cost(Baseline testing (T0), score changes after the 4 weeks in-hospital treatment (T1), score changes after the 3-months asynchronous telerehabilitation intervention (T1) and score changes at follow up, 3 months after telerehabilitation intervetion (T3))
- Change in auditory information processing speed and flexibility(Baseline testing (T0), score changes after the 4 weeks in-hospital treatment (T1), score changes after the 3-months asynchronous telerehabilitation intervention (T1) and score changes at follow up, 3 months after telerehabilitation intervetion (T3))
- Change in ability to modify balance while walking in the presence of external demands(Baseline testing (T0), score changes after the 4 weeks in-hospital treatment (T1), score changes after the 3-months asynchronous telerehabilitation intervention (T1) and score changes at follow up, 3 months after telerehabilitation intervetion (T3))
- Change in dynamic balance during an activity requiring weight-shift and movement while in single-leg stance(Baseline testing (T0), score changes after the 4 weeks in-hospital treatment (T1), score changes after the 3-months asynchronous telerehabilitation intervention (T1) and score changes at follow up, 3 months after telerehabilitation intervetion (T3))
- Change in ability to transition from a supine positon to a standing position.(Baseline testing (T0), score changes after the 4 weeks in-hospital treatment (T1), score changes after the 3-months asynchronous telerehabilitation intervention (T1) and score changes at follow up, 3 months after telerehabilitation intervetion (T3))
- Change in functional lower extremity strength(Baseline testing (T0), score changes after the 4 weeks in-hospital treatment (T1), score changes after the 3-months asynchronous telerehabilitation intervention (T1) and score changes at follow up, 3 months after telerehabilitation intervetion (T3))
- Change in Walking capacity(Baseline testing (T0), score changes after the 4 weeks in-hospital treatment (T1), score changes after the 3-months asynchronous telerehabilitation intervention (T1) and score changes at follow up, 3 months after telerehabilitation intervetion (T3))
- Change in Subjective Trait Fatigue(Baseline testing (T0), score changes after the 4 weeks in-hospital treatment (T1), score changes after the 3-months asynchronous telerehabilitation intervention (T1) and score changes at follow up, 3 months after telerehabilitation intervetion (T3))
- Change in impacts of multiple sclerosis in people' lifes(Baseline testing (T0), score changes after the 4 weeks in-hospital treatment (T1), score changes after the 3-months asynchronous telerehabilitation intervention (T1) and score changes at follow up, 3 months after telerehabilitation intervetion (T3))
- Change in balance confidence(Baseline testing (T0), score changes after the 4 weeks in-hospital treatment (T1), score changes after the 3-months asynchronous telerehabilitation intervention (T1) and score changes at follow up, 3 months after telerehabilitation intervetion (T3))
- Change in perceieved impact of MS on the individual's walking ability.(Baseline testing (T0), score changes after the 4 weeks in-hospital treatment (T1), score changes after the 3-months asynchronous telerehabilitation intervention (T1) and score changes at follow up, 3 months after telerehabilitation intervetion (T3))
- Change in Walking Fatigability(Baseline testing (T0), score changes after the 4 weeks in-hospital treatment (T1), score changes after the 3-months asynchronous telerehabilitation intervention (T1) and score changes at follow up, 3 months after telerehabilitation intervetion (T3))
研究者
Sofia Straudi
MD, PhD
University Hospital of Ferrara
研究点 (1)
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