Unravelling The Optimisation And Consolidation Of Motor Skills In People With Multiple Sclerosis With Severe Gait Impairment Via High Intensity Task Oriented Circuit Training: A Feasibility Study
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 Static Balance
研究概览
简要总结
Multiple sclerosis (MS) is a progressive neurological disorder that often leads to severe gait impairment, limiting mobility and reducing the patient's quality of life. Motor rehabilitation has shown positive effects in people with MS (PwMS), but its efficacy tends to decrease as disability severity increases. High-intensity, task-oriented circuit training based on the principles of motor learning has been proposed as a potential strategy to improve motor function in severely impaired individuals.
This approach combines the benefits of high-intensity training to the motor learning principles to enhance motor skills improvement and retention.
The main questions it aims to answer are:
- Can high-intensity, task oriented training in PwMS with severe gait impairment be feasible, safe and effective in enhancing motor function?
- Can telerehabilitation maintain the benefits in gait and balance gained via circuit training for a six month period?
Participants will:
- Complete 12 session ( three 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, sit to stand, wheelchair, standing and bed mobillity.
- Engage in 3 months of asynchronous telerehabilitation (without physiotherapist supervision), including monthly televisits.
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 ≥ 6.5.
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
High Intensity Task Oriented Circuit Training + Telerehabilitation
Participants will receive 12 sessions of high-intensity, task-focused circuit training, three times a week for four weeks. Each 180-minute session includes 108 minutes of active training, with three rounds of exercises at different stations. Activities will focus on motor skills like standing, walking, transfers, and wheelchair use. If walking isn't possible, upper limb training will be included instead.
After hospital treatment, participants will continue with 36 asynchronous telerehabilitation sessions over 12 weeks, including monthly televisits, using low-cost, commercially available technology.
干预措施: High intensity task oriented circuit training + Telerehabilitation (Behavioral)
结局指标
主要结局
Change in Static 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 static balance will be assessed using the Berg Balance Scale
次要结局
- 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 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 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 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))
- Changes 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 cardiovascular fitness(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 functional performance of the upper extremity(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 self perceived manual 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