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

NCT07621679 | Recruiting

• 1 other identifier: 2026-12401
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoporosis

Keywords

Gait; Wearable; Walking; Falls; Fracture Risk

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (9)

• Functional walking capacity

  Change from Baseline to 3 months, 6 months

• Grip strength

  Change from Baseline to 3 months, 6 months

• Balance

  Change from Baseline to 3 months, 6 months

• Functional leg muscle strength

  Change from Baseline to 3 months, 6 months

• Fear of falling

  Change from Baseline to 3 months, 6 months

Other Outcomes (2)

• Angular velocity of ankle during three phases of gait cycle, heel-strike, push-off, swing averaged over a walk of at least 50 steps

  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

  Change from Baseline to 3 months, 6 months

Study Arms (2)

Walk-BEST Immediate

EXPERIMENTAL

Assigned to receive the Heel2Toe sensor and Walk BEST intervention right away.

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.

Device: Device: Heel2Toe[TM] sensor; Behavioral: Technology-assisted therapeutic walking program

Interventions

Device: Heel2Toe[TM] sensor DEVICE

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.

Walk-BEST Delayed; Walk-BEST Immediate

Technology-assisted therapeutic walking program BEHAVIORAL

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.

Also known as: Walk BEST

Walk-BEST Delayed; Walk-BEST Immediate

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

Research Institute of the McGill University Health Centre

Montreal, Quebec, H4A 3S5, Canada

RECRUITING

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Suzanne Morin, MD

  RI-MUHC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Velizara Garkova, MSc

CONTACT

514-934-1934; velizara.garkova@rimuhc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: All participants eventually receive the intervention. The primary outcomes are feasibility outcomes. Gait quality is measured directly from the sensor and is not affected by observers.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Waist-List Control

Study Record Dates

• First Submitted: May 25, 2026
• First Posted: June 2, 2026
• Study Start: May 7, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)