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NCT Number: NCT07621679

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

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.

Recruiting

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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Research Institute of the McGill University Health Centre

Montreal, Quebec, H4A 3S5, Canada

Location status: Recruiting

Location contact

Suzanne Morin, MD

PRINCIPAL_INVESTIGATOR

CONTACT

5149341934

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Other names: Walk BEST

Primary outcomes

  1. Study recruitment rates (feasibility objective)

    Time frame: 3 months

    The study will be considered feasible if the investigator can recruit 28 participants

  2. Study retention rates (feasibility objective)

    Time frame: 9 months

    The study will be considered feasible if ≥ 75 % of the sample completes the final assessment

  3. 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.

  4. 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.

Secondary outcomes

  1. Functional walking capacity

    Time frame: Change from Baseline to 3 months, 6 months

    Six Minute Walk Test (6MWT)

  2. Grip strength

    Time frame: Change from Baseline to 3 months, 6 months

    Hand Dynamometer

  3. Balance

    Time frame: Change from Baseline to 3 months, 6 months

    Mini-Best Test (0-28; higher is better)

  4. Functional leg muscle strength

    Time frame: Change from Baseline to 3 months, 6 months

    30-second Chair stand test

  5. Fear of falling

    Time frame: Change from Baseline to 3 months, 6 months

    6-Item Revised Fear of Falling Questionnaire (6-24, lower is better)

  6. Physical activity

    Time frame: Change from Baseline to 3 months, 6 months

    Physical Activity Scale for the elderly (0-400+; higher is better)

  7. Lower limb function

    Time frame: Change from Baseline to 3 months, 6 months

    Lower Extremity Functional Scale (0-80; higher is better)

  8. Quality of Life

    Time frame: Change from Baseline to 3 months, 6 months

    Older Persons Active Living Related Quality of Life (8-32, higher is better)

  9. Falls

    Time frame: Change from Baseline to 3 months, 6 months

    Number of falls reported in the falls calendar

Other outcomes

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

    Time frame: Change from Baseline to 3 months, 6 months

    Degrees per second

  2. 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

    Time frame: Change from Baseline to 3 months, 6 months

    Degrees per second

Study contacts

Contact information is provided by the study sponsor or research team.

Velizara Garkova, MSc

CONTACT

[email protected]

514-934-1934 ext. 47071

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Acronym: Walk-BEST

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 2, 2026
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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