Physical Telerehabilitation in Patients With Multiple Sclerosis With Significant Mobility Impairment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Cardiorespiratory fitness
研究概览
简要总结
The study aims to evaluate the efficacy of the MS HAT (Multiple Sclerosis Home Automated Telemanagement) System as an adjunct to the current standard of medical care for patients with MS (PwMS). The individual patient with MS will be the unit of analysis. For each participant, the investigators will assess the effect of Home Automated Telemanagement (HAT) on functional outcomes, levels of disablement including impairment, activity and participation, socio-behavioral parameters, and satisfaction with medical care as described below.
详细描述
People with multiple sclerosis may develop severe disability over the time. Physical therapy including regular exercise helps patients with severe disability to maintain muscle strength, reduce disease symptoms and improve quality of life. However physical therapy programs at clinical settings require constant travel which may limit access of patients with mobility disability to these services on continuous basis.Technology can allow patients with mobility disability exercise at home under supervision of their rehabilitation team. Currently it is unclear how effective this approach is. The study aims to demonstrate that the patients who were helped by the new technology to exercise at home will have better fitness, less symptoms and better quality of life. If so, other patients with significant mobility disability will be able to take advantage of this technology. This approach can be extended to people with different diseases causing mobility impairment and it can be used not only for physical but also for cognitive and occupational rehabilitation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of Multiple Sclerosis based on McDonald criteria
- •EDSS range 5.0-8.0
- •Mini-Mental State Examination (MMSE) > 22 or presence of a caregiver to assist in daily exercise regimen
排除标准
- •Coronary artery disease
- •Congestive Heart Failure
- •Uncontrolled hypertension
- •Pacemaker or implanted defibrillator
- •Unstable fractures or other musculoskeletal diagnoses
研究组 & 干预措施
Home Telerehabilitation
The physical telerehabilitation group will receive an exercise plan, exercise equipment, a computer, and access to a daily individualized exercise plan. Participants in this group will follow the exercise plan that is sent to their computer via the telerehabilitation software. Participants will have interactions with a physical therapist and an exercise physiologist throughout training intervention.
干预措施: Home telerehabilitation (Other)
Usual Care
The usual care group will receive an individualized exercise program at baseline however participants will not receive the home telerehabilitation system or exercise equipment. Participants assigned to the usual care group will also not have access to the study physical therapist or exercise physiologist during the intervention.
干预措施: Usual Care (Other)
结局指标
主要结局
Cardiorespiratory fitness
时间窗: Baseline up to 6 months
Cardiorespiratory fitness will be measured by oxygen consumption
次要结局
- Exercise adherence(Baseline up to 6 months)
- MS Self-efficacy scale(Baseline up to 6 months)
- Center for Epidemiologic Studies Depression Scale (CES-D)(Baseline up to 6 months)
- Berg Balance Scale (BBS)(Baseline up to 6 months)
- 2-Minute Walk Test (2MWT)(Baseline up to 6 months)
研究者
Joel Stein, MD
Simon Baruch Professor of Physical Medicine & Rehabilitation
Columbia University