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

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.

Study Overview

• Status: Recruiting
• Conditions: Osteoporosis
• Intervention / Treatment: Device: Device: Heel2Toe[TM] sensor; Behavioral: Technology-assisted therapeutic walking program

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 Type: Interventional
• Enrollment (Estimated): 28
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Velizara Garkova, MSc; Phone Number: 47071 514-934-1934; Email: velizara.garkova@rimuhc.ca

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H4A 3S5
      • Recruiting
      • Research Institute of the McGill University Health Centre
      • Contact: Phone Number: 5149341934
      • Principal Investigator: Suzanne Morin, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Walk-BEST Immediate; Assigned to receive the Heel2Toe sensor and Walk BEST intervention right away.	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.; Other Names: Walk BEST
Active Comparator: Walk-BEST Delayed; Assigned to receive the Heel2Toe sensor and Walk BEST intervention after a delay of 3 months.	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.; Other Names: Walk BEST

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study recruitment rates (feasibility objective)	The study will be considered feasible if the investigator can recruit 28 participants	3 months
Study retention rates (feasibility objective)	The study will be considered feasible if ≥ 75 % of the sample completes the final assessment	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.	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.	9 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Angular velocity of ankle during three phases of gait cycle, heel-strike, push-off, swing averaged over a walk of at least 50 steps	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	Degrees per second	Change from Baseline to 3 months, 6 months

Collaborators and Investigators

• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Investigators: Principal Investigator: Suzanne Morin, MD, RI-MUHC

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: May 25, 2026
• First Submitted That Met QC Criteria: May 29, 2026
• First Posted (Actual): June 2, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Gait; Walking; Falls; Wearable; Fracture Risk
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Bone Diseases, Metabolic; Nutritional and Metabolic Diseases; Osteoporosis
• Other Study ID Numbers: 2026-12401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No