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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.
• Поведенческое 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.

Первичные конечные точки

• Study recruitment rates (feasibility objective) [Срок оценки: 3 months]
• Study retention rates (feasibility objective) [Срок оценки: 9 months]
• Adherence to intervention (feasibility objective) [Срок оценки: 9 months]
• Perceived acceptability and usability of the Heel2Toe sensor (feasibility objective) [Срок оценки: 9 months]

Вторичные конечные точки (9)

• Functional walking capacity [Срок оценки: Change from Baseline to 3 months, 6 months]
• Grip strength [Срок оценки: Change from Baseline to 3 months, 6 months]
• Balance [Срок оценки: Change from Baseline to 3 months, 6 months]
• Functional leg muscle strength [Срок оценки: Change from Baseline to 3 months, 6 months]
• Fear of falling [Срок оценки: Change from Baseline to 3 months, 6 months]
• Physical activity [Срок оценки: Change from Baseline to 3 months, 6 months]
• Lower limb function [Срок оценки: Change from Baseline to 3 months, 6 months]
• Quality of Life [Срок оценки: Change from Baseline to 3 months, 6 months]
• Falls [Срок оценки: Change from Baseline to 3 months, 6 months]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Research Institute of the McGill University Health Centre — Montreal

Идентификаторы

NCT: NCT07621679 · 2026-12401

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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