OsteoporosisWalk-BESTNCT07621679
People With Osteoporosis Can Walk-BEST to Reduce Fall and Fracture Risk
A study testing Device: Heel2Toe[TM] sensor and Technology-assisted therapeutic walking program in people with Osteoporosis, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Device: Heel2Toe[TM] sensor and Technology-assisted therapeutic walking program
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteCanada
- Study dates
- 7 May 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Research Institute of the McGill University Health Centre
Montreal, Quebec, H4A 3S5
5149341934
Suzanne Morin, MD
About this study
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.
Read the 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.
- Conditions
- Osteoporosis
- Being tested
- Device: Heel2Toe[TM] sensor, Technology-assisted therapeutic walking program
- Keywords
- Gait, Wearable, Walking, Falls, Fracture Risk
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device: Heel2Toe[TM] sensorDevice
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.
Technology-assisted therapeutic walking programBehavioural
Also called Walk BEST
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.
| Study group | Role | What they receive |
|---|---|---|
| Walk-BEST Immediate | Experimental | Assigned to receive the Heel2Toe sensor and Walk BEST intervention right away. Receives: Device: Device: Heel2Toe[TM] sensor; Behavioral: Technology-assisted therapeutic walking program |
| Walk-BEST Delayed | Active comparator | Assigned to receive the Heel2Toe sensor and Walk BEST intervention after a delay of 3 months. Receives: Device: Device: Heel2Toe[TM] sensor; Behavioral: Technology-assisted therapeutic walking program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study recruitment rates (feasibility objective)
The study will be considered feasible if the investigator can recruit 28 participants
Measured: 3 months
Study retention rates (feasibility objective)
The study will be considered feasible if ≥ 75 % of the sample completes the final assessment
Measured: 9 months
Adherence to intervention (feasibility objective)
The intervention will be considered feasible if participants complete ≥ 65% of the prescribed number of walking sessions at the 6-month follow-up.
Measured: 9 months
Perceived acceptability and usability of the Heel2Toe sensor (feasibility objective)
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.
Measured: 9 months
Secondary outcomes (9)
Functional walking capacity
Six Minute Walk Test (6MWT)
Measured: Change from Baseline to 3 months, 6 months
Grip strength
Hand Dynamometer
Measured: Change from Baseline to 3 months, 6 months
Balance
Mini-Best Test (0-28; higher is better)
Measured: Change from Baseline to 3 months, 6 months
Functional leg muscle strength
30-second Chair stand test
Measured: Change from Baseline to 3 months, 6 months
Fear of falling
6-Item Revised Fear of Falling Questionnaire (6-24, lower is better)
Measured: Change from Baseline to 3 months, 6 months
Physical activity
Physical Activity Scale for the elderly (0-400+; higher is better)
Measured: Change from Baseline to 3 months, 6 months
Lower limb function
Lower Extremity Functional Scale (0-80; higher is better)
Measured: Change from Baseline to 3 months, 6 months
Quality of Life
Older Persons Active Living Related Quality of Life (8-32, higher is better)
Measured: Change from Baseline to 3 months, 6 months
Falls
Number of falls reported in the falls calendar
Measured: Change from Baseline to 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start7 May 2026
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Waist-List Control
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suzanne Morin, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Suzanne Morin, MD, Principal investigator, RI-MUHC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07621679
- Sponsor's protocol ID
- 2026-12401
- Acronym
- Walk-BEST
- Status last verified
- May 2026
- First submitted
- 25 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- People With Osteoporosis Can Walk-BEST to Reduce Fall and Fracture Risk
- ClinicalTrials.gov ID
- NCT07621679
- Acronym / sponsor ID
- Walk-BEST / 2026-12401
- Conditions
- Osteoporosis
- Keywords
- Gait, Wearable, Walking, Falls, Fracture Risk
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 7 May 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Waist-List Control
| Arm | Type | Receives |
|---|---|---|
| Walk-BEST Immediate | Experimental | Device: Device: Heel2Toe[TM] sensor, Behavioral: Technology-assisted therapeutic walking programAssigned to receive the Heel2Toe sensor and Walk BEST intervention right away. |
| Walk-BEST Delayed | Active comparator | Device: Device: Heel2Toe[TM] sensor, Behavioral: Technology-assisted therapeutic walking programAssigned to receive the Heel2Toe sensor and Walk BEST intervention after a delay of 3 months. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Device: Heel2Toe[TM] sensorHeel2Toe 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. | Device | Walk-BEST Delayed, Walk-BEST Immediate |
| Technology-assisted therapeutic walking programAlso: Walk BESTCo-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. | Behavioural | Walk-BEST Delayed, Walk-BEST Immediate |
Primary outcome
Study recruitment rates (feasibility objective)
Time frame: 3 months
The study will be considered feasible if the investigator can recruit 28 participants
Study retention rates (feasibility objective)
Time frame: 9 months
The study will be considered feasible if ≥ 75 % of the sample completes the final assessment
Adherence to intervention (feasibility objective)
Time frame: 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.
Perceived acceptability and usability of the Heel2Toe sensor (feasibility objective)
Time frame: 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 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Suzanne Morin, MD principal investigator
RI-MUHC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device: Heel2Toe[TM] sensor and Technology-assisted therapeutic walking program in people with Osteoporosis, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Velizara Garkova, MSc (514-934-1934 ext. 47071, velizara.garkova@rimuhc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study recruitment rates (feasibility objective) (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.