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

NCT07741994 | Not Yet Recruiting

• 2 other identifiers: 49RC26_02722026-A01541-50
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Aging; Fall; Fall Accident

Outcome Measures

Primary Outcomes (4)

• Changes in the spatiotemporal gait parameters between V1 and V3 : walking speed Spatiotemporal gait parameters as measured using GAITRite®

  this outcome is assessed at baseline and 7 weeks (8 weeks maximum)

• Changes in the spatiotemporal gait parameters between V1 and V3 : stride length Spatiotemporal gait parameters as measured using GAITRite®

  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®

  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®

  this outcome is assessed at baseline and 7 weeks (8 weeks maximum)

Secondary Outcomes (16)

• Number of falls

  baseline, 3 weeks and 7 weeks (8 maximum)

• Gait stability measured by a smartwatch paired with an iPhone (in percentage)

  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.

  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.

  1 week and 7 weeks (8 weeks max)

• Time spent standing (minutes), measured by a smartwatch paired with an iPhone.

  1 week and 7 weeks (8 weeks max)

Study Arms (2)

Control Group

SHAM COMPARATOR

Other: Control Group

Intervention Group

ACTIVE COMPARATOR

Other: PFPP Group (Personalized Fall Prevention Program through the Stand'hop app)

Interventions

PFPP Group (Personalized Fall Prevention Program through the Stand'hop app) OTHER

Digitally assisted self-rehabilitation program in addition to standard care

Intervention Group

Control Group OTHER

Standard rehabilitation care

Control Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Angers: lead

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Cédric ANNWEILER, Pr.

  Angers Universitary Hospital (CHU)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Issam BILAL, MS

CONTACT

02.41.35.68.28; Issam.Bilal@chu-angers.fr

DRCI Promotion Interne

CONTACT

DRCI-Promotion-Interne@chu-angers.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2026
• First Posted: August 3, 2026
• Study Start (Estimated): December 5, 2026
• Primary Completion (Estimated): June 22, 2028
• Study Completion (Estimated): June 22, 2028
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share