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临床试验/NCT03230903
NCT03230903已完成不适用

Physical Telerehabilitation in Patients With Multiple Sclerosis With Significant Mobility Impairment

Columbia University1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2016年10月最近更新:
适应症

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

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joel Stein, MD

Simon Baruch Professor of Physical Medicine & Rehabilitation

Columbia University

研究点 (1)

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