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

29. maj 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

28

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H4A 3S5
        • Rekruttering
        • Research Institute of the McGill University Health Centre
        • Kontakt:
          • Telefonnummer: 5149341934
        • Ledende efterforsker:
          • Suzanne Morin, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Walk-BEST Immediate
Assigned to receive the Heel2Toe sensor and Walk BEST intervention right away.
Enhed: 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.
Adfærdsmæssigt: 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.
Andre navne:
  • Walk BEST
Aktiv komparator: Walk-BEST Delayed
Assigned to receive the Heel2Toe sensor and Walk BEST intervention after a delay of 3 months.
Enhed: 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.
Adfærdsmæssigt: 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.
Andre navne:
  • Walk BEST

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Study recruitment rates (feasibility objective)
Tidsramme: 3 months
The study will be considered feasible if the investigator can recruit 28 participants
3 months
Study retention rates (feasibility objective)
Tidsramme: 9 months
The study will be considered feasible if ≥ 75 % of the sample completes the final assessment
9 months
Adherence to intervention (feasibility objective)
Tidsramme: 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)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Functional walking capacity
Tidsramme: Change from Baseline to 3 months, 6 months
Six Minute Walk Test (6MWT)
Change from Baseline to 3 months, 6 months
Grip strength
Tidsramme: Change from Baseline to 3 months, 6 months
Hand Dynamometer
Change from Baseline to 3 months, 6 months
Balance
Tidsramme: 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
Tidsramme: Change from Baseline to 3 months, 6 months
30-second Chair stand test
Change from Baseline to 3 months, 6 months
Fear of falling
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Change from Baseline to 3 months, 6 months
Number of falls reported in the falls calendar
Change from Baseline to 3 months, 6 months

Andre resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

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

Efterforskere

  • Ledende efterforsker: Suzanne Morin, MD, RI-MUHC

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

7. maj 2026

Primær færdiggørelse (Anslået)

1. maj 2027

Studieafslutning (Anslået)

1. maj 2027

Datoer for studieregistrering

Først indsendt

25. maj 2026

Først indsendt, der opfyldte QC-kriterier

29. maj 2026

Først opslået (Faktiske)

2. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2026-12401

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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