People With Osteoporosis Can Walk-BEST to Reduce Fall and Fracture Risk (Walk-BEST)
29 de maio de 2026 atualizado 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.
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Inscrição (Estimado)
28
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Velizara Garkova, MSc
- Número de telefone: 47071 514-934-1934
- E-mail: velizara.garkova@rimuhc.ca
Locais de estudo
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Quebec
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Montreal, Quebec, Canadá, H4A 3S5
- Recrutamento
- Research Institute of the McGill University Health Centre
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Contato:
- Número de telefone: 5149341934
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Investigador principal:
- Suzanne Morin, MD
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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.
Outros nomes:
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Comparador Ativo: 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.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Study recruitment rates (feasibility objective)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Functional walking capacity
Prazo: Change from Baseline to 3 months, 6 months
|
Six Minute Walk Test (6MWT)
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Change from Baseline to 3 months, 6 months
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Grip strength
Prazo: Change from Baseline to 3 months, 6 months
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Hand Dynamometer
|
Change from Baseline to 3 months, 6 months
|
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Balance
Prazo: 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
Prazo: 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
Prazo: Change from Baseline to 3 months, 6 months
|
6-Item Revised Fear of Falling Questionnaire (6-24, lower is better)
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Change from Baseline to 3 months, 6 months
|
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Physical activity
Prazo: 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
Prazo: 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
Prazo: 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
|
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Falls
Prazo: Change from Baseline to 3 months, 6 months
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Number of falls reported in the falls calendar
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Change from Baseline to 3 months, 6 months
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Angular velocity of ankle during three phases of gait cycle, heel-strike, push-off, swing averaged over a walk of at least 50 steps
Prazo: Change from Baseline to 3 months, 6 months
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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
Prazo: Change from Baseline to 3 months, 6 months
|
Degrees per second
|
Change from Baseline to 3 months, 6 months
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Suzanne Morin, MD, RI-MUHC
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
7 de maio de 2026
Conclusão Primária (Estimado)
1 de maio de 2027
Conclusão do estudo (Estimado)
1 de maio de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
25 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
29 de maio de 2026
Primeira postagem (Real)
2 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
2 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
29 de maio de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2026-12401
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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