Changes in Spatiotemporal Gait Parameters During a Digitally Assisted Self-rehabilitation Program for Elderly Fallers ( DigiWalk ) (DigiWalk)
3 de agosto de 2026 actualizado por: University Hospital, Angers
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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Intervencionista
Inscripción (Estimado)
200
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: DRCI Promotion Interne
- Correo electrónico: DRCI-Promotion-Interne@chu-angers.fr
Copia de seguridad de contactos de estudio
- Nombre: Issam BILAL, MS
- Número de teléfono: +33 02.41.35.68.28
- Correo electrónico: Issam.Bilal@chu-angers.fr
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:
- 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)
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: Cuidados de apoyo
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador falso: Grupo de control
|
Standard rehabilitation care
|
|
Comparador activo: Grupo de Intervención
|
Digitally assisted self-rehabilitation program in addition to standard care using Personalized Fall Prevention Program (PFPP) through the Stand'hop app.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Changes in the spatiotemporal gait parameters between V1 and V3 : stride length Spatiotemporal gait parameters as measured using GAITRite®
Periodo de tiempo: 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®
Periodo de tiempo: 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®
Periodo de tiempo: 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).
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of falls
Periodo de tiempo: 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)
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 1 week and 7 weeks (8 maximum)
|
1 week and 7 weeks (8 maximum)
|
|
|
Number of hospitalizations since the V1 visit
Periodo de tiempo: 3 weeks and 7 weeks (8 maximum)
|
3 weeks and 7 weeks (8 maximum)
|
|
|
Change of residence since the V1 visit (Yes or No)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 7 weeks (8 weeks maximum)
|
7 weeks (8 weeks maximum)
|
|
|
Changes in SPPB score, at V1 and V3 Short Physical Performance Battery (SPPB) score
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Cédric ANNWEILER, Pr., Angers Universitary Hospital (CHU)
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 (Estimado)
5 de diciembre de 2026
Finalización primaria (Estimado)
22 de junio de 2028
Finalización del estudio (Estimado)
22 de junio de 2028
Fechas de registro del estudio
Enviado por primera vez
17 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
28 de julio de 2026
Publicado por primera vez (Actual)
3 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
5 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
3 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 49RC26_0272
- 2026-A01541-50 (Identificador de registro: ID-RCB)
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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