People With Osteoporosis Can Walk-BEST to Reduce Fall and Fracture Risk (Walk-BEST)
29 de mayo de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
28
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Velizara Garkova, MSc
- Número de teléfono: 47071 514-934-1934
- Correo electrónico: velizara.garkova@rimuhc.ca
Ubicaciones de estudio
-
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Quebec
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Montreal, Quebec, Canadá, H4A 3S5
- Reclutamiento
- Research Institute of the McGill University Health Centre
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Contacto:
- Número de teléfono: 5149341934
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Investigador principal:
- Suzanne Morin, MD
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
Otros nombres:
|
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Comparador activo: 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.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Study recruitment rates (feasibility objective)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
|
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Perceived acceptability and usability of the Heel2Toe sensor (feasibility objective)
Periodo de tiempo: 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.
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9 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Functional walking capacity
Periodo de tiempo: 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
Periodo de tiempo: Change from Baseline to 3 months, 6 months
|
Hand Dynamometer
|
Change from Baseline to 3 months, 6 months
|
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Balance
Periodo de tiempo: 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
Periodo de tiempo: 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
|
|
Fear of falling
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Change from Baseline to 3 months, 6 months
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Number of falls reported in the falls calendar
|
Change from Baseline to 3 months, 6 months
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Angular velocity of ankle during three phases of gait cycle, heel-strike, push-off, swing averaged over a walk of at least 50 steps
Periodo de tiempo: 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
Periodo de tiempo: Change from Baseline to 3 months, 6 months
|
Degrees per second
|
Change from Baseline to 3 months, 6 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Suzanne Morin, MD, RI-MUHC
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
7 de mayo de 2026
Finalización primaria (Estimado)
1 de mayo de 2027
Finalización del estudio (Estimado)
1 de mayo de 2027
Fechas de registro del estudio
Enviado por primera vez
25 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
29 de mayo de 2026
Publicado por primera vez (Actual)
2 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
2 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
29 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026-12401
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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