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Changes in Spatiotemporal Gait Parameters During a Digitally Assisted Self-rehabilitation Program for Elderly Fallers ( DigiWalk ) (DigiWalk)

3 augustus 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Studietype

Ingrijpend

Inschrijving (Geschat)

200

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Sham-vergelijker: Controlegroep
Ander: Control Group
Standard rehabilitation care
Actieve vergelijker: Interventie Groep
Ander: PFPP Group
Digitally assisted self-rehabilitation program in addition to standard care using Personalized Fall Prevention Program (PFPP) through the Stand'hop app.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Changes in the spatiotemporal gait parameters between V1 and V3 : stride length Spatiotemporal gait parameters as measured using GAITRite®
Tijdsspanne: 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®
Tijdsspanne: 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®
Tijdsspanne: 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).
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of falls
Tijdsspanne: 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)
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 1 week and 7 weeks (8 maximum)
1 week and 7 weeks (8 maximum)
Number of hospitalizations since the V1 visit
Tijdsspanne: 3 weeks and 7 weeks (8 maximum)
3 weeks and 7 weeks (8 maximum)
Change of residence since the V1 visit (Yes or No)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 7 weeks (8 weeks maximum)
7 weeks (8 weeks maximum)
Changes in SPPB score, at V1 and V3 Short Physical Performance Battery (SPPB) score
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: baseline and 7 weeks (8 weeks maximum)
_ /4; 0 being the worse and 4 the better
baseline and 7 weeks (8 weeks maximum)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University Hospital, Angers

Onderzoekers

  • Hoofdonderzoeker: Cédric ANNWEILER, Pr., Angers Universitary Hospital (CHU)

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

5 december 2026

Primaire voltooiing (Geschat)

22 juni 2028

Studie voltooiing (Geschat)

22 juni 2028

Studieregistratiedata

Eerst ingediend

17 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

28 juli 2026

Eerst geplaatst (Werkelijk)

3 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

5 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

3 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 49RC26_0272
  • 2026-A01541-50 (Register-ID: ID-RCB)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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