People With Osteoporosis Can Walk-BEST to Reduce Fall and Fracture Risk (Walk-BEST)
29. mai 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Antatt)
28
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Velizara Garkova, MSc
- Telefonnummer: 47071 514-934-1934
- E-post: velizara.garkova@rimuhc.ca
Studiesteder
-
-
Quebec
-
Montreal, Quebec, Canada, H4A 3S5
- Rekruttering
- Research Institute of the McGill University Health Centre
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Ta kontakt med:
- Telefonnummer: 5149341934
-
Hovedetterforsker:
- Suzanne Morin, MD
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Eldre voksen
Tar imot friske frivillige
Nei
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Walk-BEST Immediate
Assigned to receive the Heel2Toe sensor and Walk BEST intervention right away.
|
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.
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 navn:
|
|
Aktiv komparator: Walk-BEST Delayed
Assigned to receive the Heel2Toe sensor and Walk BEST intervention after a delay of 3 months.
|
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.
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 navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Study recruitment rates (feasibility objective)
Tidsramme: 3 months
|
The study will be considered feasible if the investigator can recruit 28 participants
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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
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9 months
|
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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 |
Tiltaksbeskrivelse |
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
|
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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
|
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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
|
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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
|
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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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Suzanne Morin, MD, RI-MUHC
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
7. mai 2026
Primær fullføring (Antatt)
1. mai 2027
Studiet fullført (Antatt)
1. mai 2027
Datoer for studieregistrering
Først innsendt
25. mai 2026
Først innsendt som oppfylte QC-kriteriene
29. mai 2026
Først lagt ut (Faktiske)
2. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
2. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
29. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2026-12401
Plan for individuelle deltakerdata (IPD)
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NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
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Nei
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