People With Osteoporosis Can Walk-BEST to Reduce Fall and Fracture Risk
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Device: Heel2Toe[TM] sensor, Technology-assisted therapeutic walking program.
- Who it may be relevant to
- Registry conditions: Osteoporosis. Basic parameters: from 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed description
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.
Interventions
- Device 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. - Behavioral 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.
Primary outcome measures
- Study recruitment rates (feasibility objective) [Time frame: 3 months]
- Study retention rates (feasibility objective) [Time frame: 9 months]
- Adherence to intervention (feasibility objective) [Time frame: 9 months]
- Perceived acceptability and usability of the Heel2Toe sensor (feasibility objective) [Time frame: 9 months]
Secondary outcome measures (9)
- Functional walking capacity [Time frame: Change from Baseline to 3 months, 6 months]
- Grip strength [Time frame: Change from Baseline to 3 months, 6 months]
- Balance [Time frame: Change from Baseline to 3 months, 6 months]
- Functional leg muscle strength [Time frame: Change from Baseline to 3 months, 6 months]
- Fear of falling [Time frame: Change from Baseline to 3 months, 6 months]
- Physical activity [Time frame: Change from Baseline to 3 months, 6 months]
- Lower limb function [Time frame: Change from Baseline to 3 months, 6 months]
- Quality of Life [Time frame: Change from Baseline to 3 months, 6 months]
- Falls [Time frame: Change from Baseline to 3 months, 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- Research Institute of the McGill University Health Centre — Montreal
Identifiers
NCT: NCT07621679 · 2026-12401