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临床试验/NCT04265664
NCT04265664已完成不适用

Telerehabilitation With Aims to Improve Lower Extremity Recovery Post-Stroke

University of British Columbia10 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2020年7月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
10
主要终点
Change from baseline Timed Up and Go (TUG) at 4 weeks

研究概览

简要总结

The purpose of this study is to examine the feasibility and effectiveness of a lower extremity telerehabilitation protocol with aims to improve lower extremity recovery among community-living stroke survivors across Canada.

详细描述

Eighty percent of stroke survivors experience some form of motor impairment, such as loss or limitation of function in muscle control or movement, or mobility limitation. Regaining walking ability is a priority for most and is achieved in approximately 80%. Unfortunately, the occurrence of falling while walking is as high as 73% of all people who recover the ability to walk post-stroke, with falls often occurring within the first few months of returning home from rehabilitation. This highlights the challenges with transitioning to the community for continued post-stroke rehabilitation. Unfortunately, due to increasing demand on our healthcare and rehabilitation systems and limited service capacity, stroke survivors receive minimal to no follow-up rehabilitation after returning to community-living. As a result, it is common for stroke survivors to report unmet lower extremity rehabilitation needs, and thus ongoing walking/mobility impairment, balance issues, high incidence of falls, and difficulties participating in desired social roles.

The rapid growth in the use of the Internet and personal mobile technologies, including computers, smartphones, and tablets has opened up an array of possibilities through which patients can remotely access specialized health services, such as telerehabilitation supports, while in their homes and communities. The use of technologies to facilitate optimal rehabilitation and recovery after stroke is under-utilized in Canada, despite being highly recommended in Canadian stroke guidelines, and positive beliefs about its potential among people with stroke.

Objectives:

  1. To examine the feasibility (e.g. safety, recruitment rate, retention rate, fidelity and adherence, burden) of a lower extremity telerehabilitation protocol among community-living stroke survivors
  2. To estimate the size of effect of TRAIL on clinical outcomes of functional mobility, lower extremity strength and motor impairment, functional balance, quality of life, balance self-efficacy, and goal attainment among community-living stroke survivors

Hypotheses:

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
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 19 year of age or older;
  • Within 18 months of the most recent stroke;
  • Hemiparesis of the lower extremity;
  • Able to walk 10m without physical assistance;
  • Able to tolerate 50 minutes of activity (including rest breaks, as needed);
  • Have cognitive-communicative ability to participate as per clinical judgement
  • Able to provide informed consent;

排除标准

  • Currently receiving in- or outpatient rehabilitation;
  • Living in long-term care;
  • Severe vision or hearing loss;
  • Other neurological conditions, e.g. Parkinson's disease;
  • Presence of significant comorbidities (e.g. severe osteoarthritis), pain or other symptoms that significantly impact lower extremity function;
  • Planned surgery that would preclude or affect participation in the protocol

结局指标

主要结局

Change from baseline Timed Up and Go (TUG) at 4 weeks

时间窗: Baseline, Post-Intervention (immediately following 4 weeks of intervention)

Performance walking test to assess functional mobility.

次要结局

  • Stroke Impact Scale (SIS)(Baseline, Post-Intervention (immediately following 4 weeks of intervention))
  • Activities-Specific Balance (ABC) Scale(Baseline, Post-Intervention (immediately following 4 weeks of intervention))
  • Functional Reach(Baseline, Post-Intervention (immediately following 4 weeks of intervention))
  • Goal Attainment Scale(Baseline, Post-Intervention (immediately following 4 weeks of intervention))
  • Tandem Stand(Baseline, Post-Intervention (immediately following 4 weeks of intervention))
  • modified virtual Fugl-Meyer Assessment(Baseline, Post-Intervention (immediately following 4 weeks of intervention))
  • 30 second Sit to Stand(Baseline, Post-Intervention (immediately following 4 weeks of intervention))

研究者

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

Brodie Sakakibara

Assistant Professor

University of British Columbia

研究点 (10)

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