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

29 mei 2026 bijgewerkt door: Suzanne Morin, McGill University Health Centre/Research Institute of the McGill University Health Centre
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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

28

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H4A 3S5
        • Werving
        • Research Institute of the McGill University Health Centre
        • Contact:
          • Telefoonnummer: 5149341934
        • Hoofdonderzoeker:
          • Suzanne Morin, MD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Walk-BEST Immediate
Assigned to receive the Heel2Toe sensor and Walk BEST intervention right away.
Apparaat: 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.
Gedragsmatig: 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.
Andere namen:
  • Walk BEST
Actieve vergelijker: Walk-BEST Delayed
Assigned to receive the Heel2Toe sensor and Walk BEST intervention after a delay of 3 months.
Apparaat: 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.
Gedragsmatig: 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.
Andere namen:
  • Walk BEST

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Study recruitment rates (feasibility objective)
Tijdsspanne: 3 months
The study will be considered feasible if the investigator can recruit 28 participants
3 months
Study retention rates (feasibility objective)
Tijdsspanne: 9 months
The study will be considered feasible if ≥ 75 % of the sample completes the final assessment
9 months
Adherence to intervention (feasibility objective)
Tijdsspanne: 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.
9 months
Perceived acceptability and usability of the Heel2Toe sensor (feasibility objective)
Tijdsspanne: 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.
9 months

Secundaire uitkomstmaten

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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Angular velocity of ankle during three phases of gait cycle, heel-strike, push-off, swing averaged over a walk of at least 50 steps
Tijdsspanne: Change from Baseline to 3 months, 6 months
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
Tijdsspanne: Change from Baseline to 3 months, 6 months
Degrees per second
Change from Baseline to 3 months, 6 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

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

Onderzoekers

  • Hoofdonderzoeker: Suzanne Morin, MD, RI-MUHC

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

7 mei 2026

Primaire voltooiing (Geschat)

1 mei 2027

Studie voltooiing (Geschat)

1 mei 2027

Studieregistratiedata

Eerst ingediend

25 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

29 mei 2026

Eerst geplaatst (Werkelijk)

2 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

2 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

29 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2026-12401

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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