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

ConditionOsteoporosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age70+
SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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 design

Design model

Crossover

Treatments tested in this trial

  • 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.

Treatment groups

28 Participants
are divided into 2 treatment groups
Group A: Walk-BEST ImmediateExperimental treatment 2 interventions
Group B: Walk-BEST DelayedActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Study recruitment rates (feasibility objective)

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

Time frame
3 months
2

Study retention rates (feasibility objective)

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

Time frame
9 months
3

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.

Time frame
9 months
4

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.

Time frame
9 months

Secondary outcomes

1

Functional walking capacity

Six Minute Walk Test (6MWT)

Time frame
Change from Baseline to 3 months, 6 months
2

Grip strength

Hand Dynamometer

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

Balance

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

Time frame
Change from Baseline to 3 months, 6 months
4

Functional leg muscle strength

30-second Chair stand test

Time frame
Change from Baseline to 3 months, 6 months

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

Degrees per second

Time frame
Change from Baseline to 3 months, 6 months
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

Degrees per second

Time frame
Change from Baseline to 3 months, 6 months

Sponsors and contacts

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