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Frequent Fallers' Experiences of an Adapted Walking Frame, Designed to Reduce the Walking Aid's Associated Falls Risk (Walker)

2018年1月26日 更新者:Birmingham Community Healthcare NHS

A Pilot Investigation Into Frequent Fallers' Experiences of an Adapted Walking Frame, Designed to Reduce the Walking Aid's Associated Falls Risk

For some patients with mobility issues, a walking frame (commonly known as a zimmer frame - trademark of Zimmer Holdings), is provided to keep them on their feet and help them remain more independent in their home and when out and about. When patients are given the walking frame, they are given information on how to use it safely to protect them from hurting themselves. For a small group of patients, using the walking frame is difficult, and they will have a fall because they are unable to use the frame safely. For these patients, a fear of falling can then develop and they can then have more falls. It is thought that these falls with the walking frame happen because the patient steps too far into the frame, making them unstable. We have made an attachment for a standard walking frame, which we are calling the Step Right Buddy, that we think will help improve the stability of patients who step too far into the frame. We have attached a detachable elasticated band across the back legs of the frame to make patients aware that they have stepped far enough into the frame, to stop them stepping any further. In order to develop this further, we need to understand how people feel using this adapted frame and whether there are any new risks to the user.

The investigators propose to ask patients who are considered to be at risk of falling because of the way they use their walking frame if they would like to use the adapted walking frame in their home, instead of their standard frame, for a week. At the end of this week, investigators will spend up to an hour with this patient, talking with them about their experience of the adapted walking frame, in order to understand things such as how they felt using the frame, were they more or less fearful of using it than their usual frame, did they think they were going to fall over more or less often, do they think they fall more or less often. In addition to this, patients will keep a written record of when they thought they nearly fell, or when they had an injury whilst using the adapted walking frame. This information will be used to explore whether or not the adaption to the frame introduces new risks to patients.

研究概览

地位

完全的

条件

详细说明

Title: A pilot investigation into frequent fallers' experiences of an adapted walking frame, designed to reduce the walking aid's associated falls risk.

Short title: The Walker Study

Chief Investigator: Dr Sarahjane Jones

Objectives:

To qualitatively explore the user's experience of the Step Right Buddy after a one week pilot trial and to assess the introduction of new risks to the patient as a result of the adaptation.

Trial configuration:

Qualitatively assessed clinical trial of a novel product.

Setting: Community care - patient homes.

Sample size: 20

Description of intervention: Application of the Step Right Buddy to the standard walking frame for patients to use as normal at home for one week.

Study duration:

Project length: March 2017 - July 2017

Length of participation - 1 week from consent

Randomisation and blinding: Single arm, open trial

Outcome measures: Participants' experiences of using the Step Right Buddy and adverse event data.

Analysis techniques: Framework analysis of textual data regarding the participants experiences and, where appropriate, root cause analysis of adverse events.

研究类型

介入性

注册 (实际的)

17

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • West Midlands
      • Birmingham、West Midlands、英国、B7 4BN
        • Clive Thursfield

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Purposively sampled as those identified as 'fallers' as a result of their use of the walking frame or at risk of falling currently on the case load of the rehabilitation team within Birmingham Community Healthcare NHS Trust
  • Routinely use walking frame to manoeuvre around the house and/or outside
  • 18 years old or greater (no upper age limit)
  • Have no visual impairments
  • Must have mental capacity to consent for themselves
  • Must speak, read and comprehend English to participate in the interview

Exclusion Criteria:

  • This are not perceived to be at risk of falling as a result of their use of the walking frame
  • Are younger than 18 years of age
  • Are visually impaired
  • Do not have mental capacity to consent for themselves
  • Cannot comprehend written and spoken English sufficiently to give informed consent
  • Are unable to follow the safety instructions for using the Step Right Buddy

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:设备可行性
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Step Right Buddy arm
To use modified walking frame using the Step Right Buddy
The Step Right Buddy, which is under investigation in this clinical study, is an elasticated band that attached by Velcro to the back legs of a standard walking frame. The purpose of the Step Right Buddy is to provide sensory feedback to standard walking frame users of how far to step in to the frame and to encourage them to move the frame forward.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
User experience
大体时间:1 week
User experience will be assessed by asking the patient to trial the attachment for one week, completing a risk form during this week and providing verbal feedback at the end of this week.
1 week

次要结果测量

结果测量
措施说明
大体时间
Adverse events
大体时间:1 week
To assess the introduction of new risks to the patient as a result of the adaptation
1 week

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Sarahjane Jones, PhD、Honorary contract - Birmingham Commnity Healthcare NHS Foundation Trust (substantive post with Birmingham City University)

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年5月18日

初级完成 (实际的)

2017年6月30日

研究完成 (实际的)

2017年6月30日

研究注册日期

首次提交

2017年2月20日

首先提交符合 QC 标准的

2018年1月26日

首次发布 (实际的)

2018年2月5日

研究记录更新

最后更新发布 (实际的)

2018年2月5日

上次提交的符合 QC 标准的更新

2018年1月26日

最后验证

2018年1月1日

更多信息

与本研究相关的术语

其他研究编号

  • 216488

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

NA we are not making IPD available to other researchers.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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