Recruiting

Walk-BEST™

Sponsor:

McGill University Health Centre/Research Institute of the McGill University Health Centre

Code:

NCT07621679

Conditions

Osteoporosis

Eligibility Criteria

Sex: All

Age: 70+

Healthy Volunteers: Not accepted

Interventions

Device: Heel2Toe[TM] sensor

Technology-assisted therapeutic walking program

Study Details

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

Study ID

NCT07621679

Start date

May 7, 2026

Status verified date

May, 2026

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

28 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Walk-BEST Immediate

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

active comparator: Walk-BEST Delayed

Assigned to receive the Heel2Toe sensor and Walk BEST intervention after a delay of 3 months.

Interventions

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.

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Velizara Garkova, MSc

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

Locations

Research Institute of the McGill University Health Centre

Recruiting

Montreal, Quebec, Canada, H4A 3S5

Contacts

5149341934

Principal Investigator:

Suzanne Morin, MD

More Information

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Last update posted

Jun 2, 2026

Last verified

May, 2026

Keywords

  • Gait
  • Wearable
  • Walking
  • Falls
  • Fracture Risk

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2026-06-02.