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People With Osteoporosis Can Walk-BEST to Reduce Fall and Fracture Risk (Walk-BEST)

2026年5月29日 更新者：Suzanne Morin、McGill University Health Centre/Research Institute of the McGill University Health Centre
The aim of the Walk BEST study is to provide evidence that it is feasible to implement the technology assisted gait- focused walking program Walk-BEST™ in older adults with osteoporosis, and that this program is acceptable to this population.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

The Walk-BEST™ technology assisted gait optimization program has demonstrated effectiveness in improving gait pattern and walking capacity without adverse events in people living with Parkinson's and Multiple Sclerosis. What is not known and the topic of this pilot and feasibility study is whether older people with osteoporosis will engage successfully with this program, since they do not have a diagnosis of a disabling condition affecting gait and may be unaware that their cautious method of walking exposes them to higher risk of falls and fractures rather than protecting them.

A randomized pilot and feasibility study (PAFS) will be conducted with groups randomized in a 1:1 ratio. Participants will be randomly assigned to either 1) immediate receipt of the Walk-BEST™ program; or 2) wait-list control and delayed receipt of Walk-BEST™ program 3 months post-randomization.

Participants will receive a copy of a proprietary workbook with instructions on simple exercises targeting strength, flexibility, and balance to facilitate a better walking pattern, as well as both 3-5 remote sessions with an exercise professional to practice walking well and to learn how to use the Heel2ToeTM sensor, and two technology phone calls with a research team member, over the first 4 weeks of the intervention. This personal gait training period will be followed by independent home practice over 2 months, during which participants will be instructed to practice walking with the sensor for a minimum period of 6 min, twice a day and to complete three exercises from their workbook at least twice a week.

There will be three on-site study visits at 3-month intervals: one for initial assessment, and two for reassessment.

研究类型

介入性

注册 (估计的)

28

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。

学习联系方式

学习地点

  • 加拿大
    • Quebec
      • Montreal、Quebec、加拿大、H4A 3S5
        • 招聘中
        • Research Institute of the McGill University Health Centre
        • 接触：
          • 电话号码：5149341934
        • 首席研究员：
          • Suzanne Morin, MD

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

  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • men and women 70 years and older
  • able to walk independently with or without a walking aid
  • experienced a prior fracture after the age of 40, OR two falls in the past 12 months, OR who have a bone mineral density test (done as part of routine clinical evaluation) with a T-score < -2.5, OR on a Health Canada-approved anti-osteoporosis medication (oral or intravenous bisphosphonate, denosumab, teriparatide, or romozosumab) to reduce fracture risk or on a bisphosphonate drug holiday (planned treatment interruption)

Exclusion Criteria:

  • fracture sustained in the past 12 months
  • unable to walk unsupervised because of active medical or neurocognitive reasons
  • unable to provide informed consent, or cannot communicate in English or French

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：治疗
  • 分配：随机化
  • 介入模型：交叉作业
  • 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：Walk-BEST Immediate
Assigned to receive the Heel2Toe sensor and Walk BEST intervention right away.
设备：Device: Heel2Toe[TM] sensor
Heel2Toe is a new generation of wearables that provides real-time auditory feedback when the person takes a good step, one in which the step is initiated with a strong heel strike.
行为的：Technology-assisted therapeutic walking program
Co-designed, evidence-based technology-assisted, therapeutic walking program developed by physiotherapy researchers, clinicians, and frail and non-frail seniors. It consists of training elements (derived through international consensus and endorsed by 600 older Canadians) for optimal gait pattern with the use of a biofeedback device, the Heel2Toe™ sensor, which is introduced to reinforce the gait optimizing training and encourage home practice.
其他名称：
  • Walk BEST
有源比较器：Walk-BEST Delayed
Assigned to receive the Heel2Toe sensor and Walk BEST intervention after a delay of 3 months.
设备：Device: Heel2Toe[TM] sensor
Heel2Toe is a new generation of wearables that provides real-time auditory feedback when the person takes a good step, one in which the step is initiated with a strong heel strike.
行为的：Technology-assisted therapeutic walking program
Co-designed, evidence-based technology-assisted, therapeutic walking program developed by physiotherapy researchers, clinicians, and frail and non-frail seniors. It consists of training elements (derived through international consensus and endorsed by 600 older Canadians) for optimal gait pattern with the use of a biofeedback device, the Heel2Toe™ sensor, which is introduced to reinforce the gait optimizing training and encourage home practice.
其他名称：
  • Walk BEST

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
Study recruitment rates (feasibility objective)
大体时间：3 months
The study will be considered feasible if the investigator can recruit 28 participants
3 months
Study retention rates (feasibility objective)
大体时间：9 months
The study will be considered feasible if ≥ 75 % of the sample completes the final assessment
9 months
Adherence to intervention (feasibility objective)
大体时间：9 months
The intervention will be considered feasible if participants complete ≥ 65% of the prescribed number of walking sessions at the 6-month follow-up.
9 months
Perceived acceptability and usability of the Heel2Toe sensor (feasibility objective)
大体时间：9 months
The acceptability outcomes will be based on an exit debriefing questionnaire. Usability of the Heel2Toe sensor will be quantified with items from the Digital Health Devices Usability Indicators.
9 months

次要结果测量

结果测量
措施说明
大体时间
Functional walking capacity
大体时间：Change from Baseline to 3 months, 6 months
Six Minute Walk Test (6MWT)
Change from Baseline to 3 months, 6 months
Grip strength
大体时间：Change from Baseline to 3 months, 6 months
Hand Dynamometer
Change from Baseline to 3 months, 6 months
Balance
大体时间：Change from Baseline to 3 months, 6 months
Mini-Best Test (0-28; higher is better)
Change from Baseline to 3 months, 6 months
Functional leg muscle strength
大体时间：Change from Baseline to 3 months, 6 months
30-second Chair stand test
Change from Baseline to 3 months, 6 months
Fear of falling
大体时间：Change from Baseline to 3 months, 6 months
6-Item Revised Fear of Falling Questionnaire (6-24, lower is better)
Change from Baseline to 3 months, 6 months
Physical activity
大体时间：Change from Baseline to 3 months, 6 months
Physical Activity Scale for the elderly (0-400+; higher is better)
Change from Baseline to 3 months, 6 months
Lower limb function
大体时间：Change from Baseline to 3 months, 6 months
Lower Extremity Functional Scale (0-80; higher is better)
Change from Baseline to 3 months, 6 months
Quality of Life
大体时间：Change from Baseline to 3 months, 6 months
Older Persons Active Living Related Quality of Life (8-32, higher is better)
Change from Baseline to 3 months, 6 months
Falls
大体时间：Change from Baseline to 3 months, 6 months
Number of falls reported in the falls calendar
Change from Baseline to 3 months, 6 months

其他结果措施

结果测量
措施说明
大体时间
Angular velocity of ankle during three phases of gait cycle, heel-strike, push-off, swing averaged over a walk of at least 50 steps
大体时间：Change from Baseline to 3 months, 6 months
Degrees per second
Change from Baseline to 3 months, 6 months
Co-efficient of variation of angular velocity of ankle during three phases of gait cycle, heel-strike, push-off, swing averaged over a walk of at least 50 steps
大体时间：Change from Baseline to 3 months, 6 months
Degrees per second
Change from Baseline to 3 months, 6 months

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。

赞助

McGill University Health Centre/Research Institute of the McGill University Health Centre

调查人员

  • 首席研究员：Suzanne Morin, MD、RI-MUHC

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)

2026年5月7日

初级完成 (估计的)

2027年5月1日

研究完成 (估计的)

2027年5月1日

研究注册日期

首次提交

2026年5月25日

首先提交符合 QC 标准的

2026年5月29日

首次发布 (实际的)

2026年6月2日

研究记录更新

最后更新发布 (实际的)

2026年6月2日

上次提交的符合 QC 标准的更新

2026年5月29日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 2026-12401

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

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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