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

3 augusti 2026 uppdaterad av: 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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

Studietyp

Interventionell

Inskrivning (Beräknad)

200

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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)

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Sham Comparator: Kontrollgrupp
Övrig: Control Group
Standard rehabilitation care
Aktiv komparator: Interventionsgrupp
Övrig: PFPP Group
Digitally assisted self-rehabilitation program in addition to standard care using Personalized Fall Prevention Program (PFPP) through the Stand'hop app.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Changes in the spatiotemporal gait parameters between V1 and V3 : stride length Spatiotemporal gait parameters as measured using GAITRite®
Tidsram: 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®
Tidsram: 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®
Tidsram: 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).
Tidsram: 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)

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University Hospital, Angers

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

5 december 2026

Primärt slutförande (Beräknad)

22 juni 2028

Avslutad studie (Beräknad)

22 juni 2028

Studieregistreringsdatum

Först inskickad

17 juli 2026

Först inskickad som uppfyllde QC-kriterierna

28 juli 2026

Första postat (Faktisk)

3 augusti 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

5 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Plan för individuella deltagardata (IPD)

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NEJ

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