Task-oriented Circuit Class Training in Multiple Sclerosis Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Feasibility of task-oriented circuit class therapy
研究概览
简要总结
Aims of the study:
This is a single blind randomized-controlled trial to test the feasibility and the effects of a task oriented training on locomotor function, mobility and balance in multiple sclerosis subjects with moderate gait impairments (EDSS 4 - 5,5). The control group will not be treated with a specific physical therapy (usual care).
Subjects and methods:
60 multiple sclerosis patients will be recruited in an outpatient rehabilitation clinic (Azienda Ospedaliero-Universitaria di Ferrara).
Informed consent will be obtained. Participants will be randomized to (TOCT) task-oriented training (experimental group) or usual care (control group) through a randomization stratification approach, according to a block randomization of 6.
The experimental group will receive 10 task-oriented training sessions over 2 weeks (5 sessions/week=intensive training). Three subjects with a supervisor physiotherapist will take part at the TOCT.
Feasibility outcome will be measured with a specific questionnaire. Treatment efficacy outcome measures will be clinical test for gait speed (10m walking test), walking endurance (six minute walking test), balance (Dynamic Gait Index) and mobility (Time Up and Go Test); a structured interview for the performance(Lower Extremity Mal); self-assessment questionnaire for motor fatigue (Fatigue Severity Scale FSS), multiple sclerosis physical and psychological impact (multiple sclerosis impact scale MSIS-29), walking ability (multiple sclerosis walking scale MSWS-12).
Outcome measures will be assessed the week before the treatment (T0), after the treatment (T1) and at 3 months follow-up (T2) to evaluate treatments retention, by a clinician blinded to the treatment.
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)
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
- •males and females,
- •community dwelling,
- •age 18 or older
- •diagnosis of multiple sclerosis in a stable phase, with relapses > 3 months prior to study enrollment
- •moderate gait impairments referred to Expanded Disability Status Scale (EDSS) between 4 and 5,5
排除标准
- •neurologic conditions in addition to multiple sclerosis that may affect motor function
- •medical conditions likely to interfere with the ability to safely complete the study
- •impaired cognitive functioning: Mini Mental Status Examination < 24
研究组 & 干预措施
Task-oriented circuit class training
Functional Circuit include 6 different work-stations in which patients exercise for 5 minutes in each one : 3 minutes exercises and 2 minutes rest. Total training takes about 30 minutes (2 laps/session over 60 minutes).
Walking endurance is trained by 30 minutes walking on the treadmill including rests if necessary.
It is a progressive circuit and subjects, while exercising, receives feedback (visual and auditory) by the physiotherapist. Rests are used to discuss about difficulties and to provide further feedbacks. One task oriented session may include up to 3 patients and lasts 120 minutes. At the end of the 2 weeks an exercises brochure will be given to patients so that they can independently train for 3 month. Independent home training takes about 90 minutes.
干预措施: Task-oriented circuit class training (Behavioral)
Usual Care
The control group will not receive any specific rehabilitation treatment for gait performance and mobility improvement (usual care). At any case, the control group will be authorized, at will, to exercise in non-rehabilitative contexts (i.e. swimming, walking, yoga) or do physical rehabilitation in rehabilitative gyms not directly addressed to gait, mobility or balance training such as stretching exercises, active and passive mobilization and Bobath neurorehabilitation or similar.
干预措施: usual care (Behavioral)
结局指标
主要结局
Feasibility of task-oriented circuit class therapy
时间窗: 12 months
It will be performed through the administration of a specific questionnaire
次要结局
- mobility(12 months)
- Balance(12 months)
- gait speed(12 months)
- walking endurance(12 months)
- Physical and psychological impact(12 months)
- fatigue(12 months)
- Impact on mobility and walking(12 months)
研究者
Sofia Straudi, MD
Physical Medicine and Rehabilitation doctor
University Hospital of Ferrara