Changes in Spatiotemporal Gait Parameters During a Digitally Assisted Self-rehabilitation Program for Elderly Fallers ( DigiWalk ) (DigiWalk)
Falls are a health issue that is both common among older adults (affecting 1 in 2 people each year after age 80) and serious due to their traumatic, psychological, and functionally disabling complications. The international literature shows that it is possible to prevent recurrent falls by addressing the risk factors for falls, particularly by combating a sedentary lifestyle and deconditioning through regular standing and mobility exercises as part of a rehabilitation program. As part of France's major national plan to prevent falls among older adults, and at a time when medicine is becoming increasingly personalized, prescribing a digitally assisted self-rehabilitation program for people over 65 following a fall could enable as many people as possible to benefit from rehabilitation that boosts their motivation and reduces the time spent by healthcare professionals, while ensuring high-quality follow-up care.
LNA Santé, in collaboration with the Angers and Nantes University Hospitals, has developed a personalized, digitally assisted fall prevention program (the Stand'hop app) comprising three types of activities: tailored physical exercises, structured lifestyle advice, and an objective measurement of the patient's physical activity. Before moving forward with a larger-scale clinical trial to evaluate the effectiveness of this personalized, digitally assisted fall prevention program, the present study DigiWalk aims to describe changes in walking performance over 7 weeks among older adults who have experienced falls, when the program is used as an adjunct to standard care, compared to changes observed in older adults who have experienced falls and receive only standard care.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
The main objective is to compare changes in spatiotemporal gait parameters, after 7 weeks of intervention, in :
- Elderly fallers with a digitally assisted self-rehabilitation program in addition to standard care
- Elderly fallers with standard rehabilitation care
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: DRCI Promotion Interne
- E-mail: DRCI-Promotion-Interne@chu-angers.fr
Estude backup de contato
- Nome: Issam BILAL, MS
- Número de telefone: +33 02.41.35.68.28
- E-mail: Issam.Bilal@chu-angers.fr
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Patients aged 65 and older Fall at least once in the previous 3 months , requiring rehabilitation care from a physical therapist
- Signed informed consent or consent from a third party (trusted individual, family member, or close relative)
- Individuals physically capable of following a rehabilitation program (standard care, with or without digital assistance) and of wearing a watch
- Individuals capable of following a self-rehabilitation program as well as the study procedures independently or with the assistance of a caregiver if needed
- Patients enrolled in or covered by a social security program
Exclusion Criteria:
- A person deprived of liberty by an administrative or judicial decision, a person undergoing involuntary psychiatric treatment, or an adult subject to a legal protective measure
- Contraindications to rehabilitation programs offered following a fall (standard care, with or without digital assistance)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Falso: Grupo de controle
|
Standard rehabilitation care
|
|
Comparador Ativo: Grupo de Intervenção
|
Digitally assisted self-rehabilitation program in addition to standard care using Personalized Fall Prevention Program (PFPP) through the Stand'hop app.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Changes in the spatiotemporal gait parameters between V1 and V3 : stride length Spatiotemporal gait parameters as measured using GAITRite®
Prazo: this outcome is assessed at baseline and 7 weeks (8 weeks maximum)
|
this outcome is assessed at baseline and 7 weeks (8 weeks maximum)
|
|
|
Changes in the spatiotemporal gait parameters between V1 and V3 : Percentage of double support time Spatiotemporal gait parameters as measured using GAITRite®
Prazo: this outcome is assessed at baseline and 7 weeks (8 weeks maximum)
|
this outcome is assessed at baseline and 7 weeks (8 weeks maximum)
|
|
|
Changes in the spatiotemporal gait parameters between V1 and V3 : Coefficient of variation of stride time Spatiotemporal gait parameters as measured using GAITRite®
Prazo: this outcome is assessed at baseline and 7 weeks (8 weeks maximum)
|
this outcome is assessed at baseline and 7 weeks (8 weeks maximum)
|
|
|
Walking speed (km/h).
Prazo: this outcome is assessed at baseline and 7 weeks (8 weeks maximum)
|
Walking speed (km/h).
Spatiotemporal gait parameters as measured using GAITRite®
|
this outcome is assessed at baseline and 7 weeks (8 weeks maximum)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of falls
Prazo: baseline, 3 weeks and 7 weeks (8 maximum)
|
baseline, 3 weeks and 7 weeks (8 maximum)
|
|
|
Gait stability measured by a smartwatch paired with an iPhone (in percentage)
Prazo: 1 week and 7 weeks (8 weeks max)
|
Apple Healthkiit / appleWalkingSteadiness : Samples that match the Walking Steadiness identifier use percentage units (described in HKUnit)
|
1 week and 7 weeks (8 weeks max)
|
|
Time spent performing activities involving whole-body movements (minutes), measured by a smartwatch paired with an iPhone.
Prazo: 1 week and 7 weeks (8 weeks max)
|
1 week and 7 weeks (8 weeks max)
|
|
|
Number of hours per day during which the participant stood and moved for at least one minute per hour. Measured by a smartwatch paired with an iPhone.
Prazo: 1 week and 7 weeks (8 weeks max)
|
1 week and 7 weeks (8 weeks max)
|
|
|
Time spent standing (minutes), measured by a smartwatch paired with an iPhone.
Prazo: 1 week and 7 weeks (8 weeks max)
|
1 week and 7 weeks (8 weeks max)
|
|
|
Maximal oxygen consumption (VO₂max), measured by a smartwatch paired with an iPhone.
Prazo: 1 week and 7 weeks (8 weeks max)
|
1 week and 7 weeks (8 weeks max)
|
|
|
Number of daily steps, measured by a smartwatch paired with an iPhone.
Prazo: 1 week and 7 weeks (8 weeks max)
|
1 week and 7 weeks (8 weeks max)
|
|
|
Changes in the number of calories burned per day Calories burned per day, are measured by a smartwatch paired with an iPhone.
Prazo: 1 week and 7 weeks (8 maximum)
|
1 week and 7 weeks (8 maximum)
|
|
|
Number of hospitalizations since the V1 visit
Prazo: 3 weeks and 7 weeks (8 maximum)
|
3 weeks and 7 weeks (8 maximum)
|
|
|
Change of residence since the V1 visit (Yes or No)
Prazo: 3 weeks and 7 weeks (8 maximum)
|
3 weeks and 7 weeks (8 maximum)
|
|
|
Changes in functional abilities measured by "Activities of Daily Living" (ADL) score (6 items)
Prazo: baseline and 7 weeks (8 weeks maximum)
|
_ /6 ; 0 being the worse and 6 the better
|
baseline and 7 weeks (8 weeks maximum)
|
|
Death (Yes or No)
Prazo: 3 weeks and 7 weeks (8 maximum)
|
3 weeks and 7 weeks (8 maximum)
|
|
|
Program adherence is measured by the number of completed self-rehabilitation sessions for Intervention Group
Prazo: 7 weeks (8 weeks maximum)
|
7 weeks (8 weeks maximum)
|
|
|
Changes in SPPB score, at V1 and V3 Short Physical Performance Battery (SPPB) score
Prazo: baseline and 7 weeks (8 weeks maximum)
|
_/12; Adding up the scores from all the tests yields an overall performance score out of 12.
A score below 8 indicates a risk of sarcopenia.
|
baseline and 7 weeks (8 weeks maximum)
|
|
Number of falls showing signs of severity
Prazo: baseline, 3 weeks and 7 weeks (8 maximum)
|
If at least one fall met the criteria for severity, how many falls show signs of severity ?
|
baseline, 3 weeks and 7 weeks (8 maximum)
|
|
Changes in functional abilities measured by Instrumental Activity of Daily Living (IADL) score (4 items)
Prazo: baseline and 7 weeks (8 weeks maximum)
|
_ /4; 0 being the worse and 4 the better
|
baseline and 7 weeks (8 weeks maximum)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Cédric ANNWEILER, Pr., Angers Universitary Hospital (CHU)
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 49RC26_0272
- 2026-A01541-50 (Identificador de registro: ID-RCB)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .