People With Osteoporosis Can Walk-BEST to Reduce Fall and Fracture Risk (Walk-BEST)
29. Mai 2026 aktualisiert von: 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.
Studienübersicht
Status
Rekrutierung
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Geschätzt)
28
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Velizara Garkova, MSc
- Telefonnummer: 47071 514-934-1934
- E-Mail: velizara.garkova@rimuhc.ca
Studienorte
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Quebec
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Montreal, Quebec, Kanada, H4A 3S5
- Rekrutierung
- Research Institute of the McGill University Health Centre
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Kontakt:
- Telefonnummer: 5149341934
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Hauptermittler:
- Suzanne Morin, MD
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Walk-BEST Immediate
Assigned to receive the Heel2Toe sensor and Walk BEST intervention right away.
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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.
Andere Namen:
|
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Aktiver 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.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Study recruitment rates (feasibility objective)
Zeitfenster: 3 months
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The study will be considered feasible if the investigator can recruit 28 participants
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3 months
|
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Study retention rates (feasibility objective)
Zeitfenster: 9 months
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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)
Zeitfenster: 9 months
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The intervention will be considered feasible if participants complete ≥ 65% of the prescribed number of walking sessions at the 6-month follow-up.
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9 months
|
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Perceived acceptability and usability of the Heel2Toe sensor (feasibility objective)
Zeitfenster: 9 months
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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.
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9 months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Functional walking capacity
Zeitfenster: Change from Baseline to 3 months, 6 months
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Six Minute Walk Test (6MWT)
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Change from Baseline to 3 months, 6 months
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Grip strength
Zeitfenster: Change from Baseline to 3 months, 6 months
|
Hand Dynamometer
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Change from Baseline to 3 months, 6 months
|
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Balance
Zeitfenster: 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
Zeitfenster: Change from Baseline to 3 months, 6 months
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30-second Chair stand test
|
Change from Baseline to 3 months, 6 months
|
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Fear of falling
Zeitfenster: 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
|
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Physical activity
Zeitfenster: 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
|
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Lower limb function
Zeitfenster: Change from Baseline to 3 months, 6 months
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Lower Extremity Functional Scale (0-80; higher is better)
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Change from Baseline to 3 months, 6 months
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Quality of Life
Zeitfenster: Change from Baseline to 3 months, 6 months
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Older Persons Active Living Related Quality of Life (8-32, higher is better)
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Change from Baseline to 3 months, 6 months
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Falls
Zeitfenster: Change from Baseline to 3 months, 6 months
|
Number of falls reported in the falls calendar
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Change from Baseline to 3 months, 6 months
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Angular velocity of ankle during three phases of gait cycle, heel-strike, push-off, swing averaged over a walk of at least 50 steps
Zeitfenster: Change from Baseline to 3 months, 6 months
|
Degrees per second
|
Change from Baseline to 3 months, 6 months
|
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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
Zeitfenster: Change from Baseline to 3 months, 6 months
|
Degrees per second
|
Change from Baseline to 3 months, 6 months
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Hauptermittler: Suzanne Morin, MD, RI-MUHC
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
7. Mai 2026
Primärer Abschluss (Geschätzt)
1. Mai 2027
Studienabschluss (Geschätzt)
1. Mai 2027
Studienanmeldedaten
Zuerst eingereicht
25. Mai 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
29. Mai 2026
Zuerst gepostet (Tatsächlich)
2. Juni 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
2. Juni 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
29. Mai 2026
Zuletzt verifiziert
1. Mai 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2026-12401
Plan für individuelle Teilnehmerdaten (IPD)
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NEIN
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Device: Heel2Toe[TM] sensor
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Nancy MayoMitacs; MedTeq; Healthy Brains for Healthy Lives; PhysioBiometrics Inc.Anmeldung auf EinladungParkinson KrankheitKanada