Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

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

3. August 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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

Studientyp

Interventionell

Einschreibung (Geschätzt)

200

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Schein-Komparator: Kontrollgruppe
Sonstiges: Control Group
Standard rehabilitation care
Aktiver Komparator: Interventionsgruppe
Sonstiges: PFPP Group
Digitally assisted self-rehabilitation program in addition to standard care using Personalized Fall Prevention Program (PFPP) through the Stand'hop app.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Changes in the spatiotemporal gait parameters between V1 and V3 : stride length Spatiotemporal gait parameters as measured using GAITRite®
Zeitfenster: 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®
Zeitfenster: 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®
Zeitfenster: 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).
Zeitfenster: 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)

Sekundäre Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University Hospital, Angers

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

5. Dezember 2026

Primärer Abschluss (Geschätzt)

22. Juni 2028

Studienabschluss (Geschätzt)

22. Juni 2028

Studienanmeldedaten

Zuerst eingereicht

17. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

28. Juli 2026

Zuerst gepostet (Tatsächlich)

3. August 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

5. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

3. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

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

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Abonnieren