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临床试验/NCT02925039
NCT02925039Unknown不适用

The "Feedback Integrated Rehabilitation for Sit-to-stand Training": a Pilot Randomised Controlled Trial Testing Clinical Acceptability and Effectiveness

University of Strathclyde2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年4月18日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
2
主要终点
sit to stand ability

研究概览

简要总结

The sit-to-stand (STS) movement is a key functional movement critical to independent living. This movement is physically demanding to conduct, especially in older adults, and in the presence of physical impairments associated with a range of conditions, such as stroke, osteoarthritis, Parkinson disease and hip arthroplasty. A limited capacity to perform this movement increases the risk of falls, dependency and increased support for personal care and rehabilitation. Restoring independence in this movement is, therefore, considered a priority for physical rehabilitation.

Sit-to-stand capacity can be regained through participating in rehabilitation exercises. Providing feedback on performance of this movement could enhance the training. Thus, it is an essential aspect of physical therapy. Healthcare providers are required to meet the needs of an increasingly frail population as well as meeting national, evidence-based, guidelines for improving outcomes in conditions such as stroke which includes an increase in the practice repetition of functional movements. Reliance on rehabilitation staff to provide practice, however, places a limit on practice volume, potentially restricting outcomes. Using technology to enhance safe, repetitive practice of this movement with minimal supervision from skilled professionals would be beneficial to patients and rehabilitation services.

The primary aim of this study is to test the acceptability and feasibility of a STS training system that enhances movement feedback to patients undergoing rehabilitation. A secondary aim is to gather data on the effectiveness of the system compared to conventional rehabilitation. This information will inform a statistically powered phase 2 trial.

详细描述

Research Design:

This is a pilot randomised controlled study to test the acceptability and feasibility of a sit-to-stand (STS) training system and gather preliminary data on its effectiveness. Participants will be randomly allocated to an experimental group where participants will receive sit to stand training enhanced by the feedback system or a control group where participants will receive the usual sit to stand training as provided by the treating therapist.

Participants and recruitment:

Patients with physical impairments that affect their capacity to perform the STS movement and who are about to start active rehabilitation will be identified by the clinical team on the ward. If individuals identified in this way indicate to the clinical team that they are willing to talk to the researcher about the study a mutually convenient time will be arranged for the researcher to speak individually to the patient about the study. An information sheet will be left with the patient and they will be encouraged to read this and speak to family and friends about their possible participation. No less than 48 hours after the information sheet is provided, the researcher will make contact with the patient to discuss their participation and take written consent if agreed. This recruitment process and their participation in the study will not interfere with discharge planning during the study.

Group allocation:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients admitted to the geriatric rehabilitation ward at Gartnavel General (Greater Glasgow and Clyde Health Board).
  • Patients with physical impairments that affect their ability to stand up from sitting (sit to stand).
  • Patients that are medically stable.
  • Patients able to give informed consent.
  • Patients able to complete a STS movement with/without the help of a mobility aid or assistance of one other person.
  • Patients able to follow a three-word instruction in English.
  • Patients unable to read feedback on a computer screen with or without the use of visual aids.
  • Patients known to be epileptic/photosensitive or experience blackouts when exposed to certain light patterns or flashing images.
  • Patients with coexisting physical impairments which prevent the practice of sit-to-stand e.g. bilateral amputee or an acute exacerbation of rheumatoid arthritis.
  • Patients not expected to survive during the period of the study
  • Patients with active dermatological problems that may preclude the use of double sided sticky tape.
  • Patients with active medical conditions that may limit prescribed mobility exercise e.g. unstable angina.

排除标准

  • 未提供

结局指标

主要结局

sit to stand ability

时间窗: 6 weeks

Five times sit to stand test

次要结局

  • Acceptability(6 weeks)

研究者

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

Andrew Kerr

Lecturer

University of Strathclyde

研究点 (2)

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