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NCT Number: NCT07741994

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

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.

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Key information

Conditions

Aging Fall Fall Accident

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

PFPP Group

Other

Digitally assisted self-rehabilitation program in addition to standard care using Personalized Fall Prevention Program (PFPP) through the Stand'hop app.

Control Group

Other

Standard rehabilitation care

Primary outcomes

  1. Walking speed (km/h).

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

    Walking speed (km/h). Spatiotemporal gait parameters as measured using GAITRite®

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

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

  3. Changes in the spatiotemporal gait parameters between V1 and V3 : Percentage of double support time Spatiotemporal gait parameters as measured using GAITRite®

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

  4. Changes in the spatiotemporal gait parameters between V1 and V3 : Coefficient of variation of stride time Spatiotemporal gait parameters as measured using GAITRite®

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

Secondary outcomes

  1. Number of falls

    Time frame: baseline, 3 weeks and 7 weeks (8 maximum)

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

    Time frame: 1 week and 7 weeks (8 weeks max)

    Apple Healthkiit / appleWalkingSteadiness : Samples that match the Walking Steadiness identifier use percentage units (described in HKUnit)

  3. Time spent performing activities involving whole-body movements (minutes), measured by a smartwatch paired with an iPhone.

    Time frame: 1 week and 7 weeks (8 weeks max)

  4. 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.

    Time frame: 1 week and 7 weeks (8 weeks max)

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

    Time frame: 1 week and 7 weeks (8 weeks max)

  6. Maximal oxygen consumption (VO₂max), measured by a smartwatch paired with an iPhone.

    Time frame: 1 week and 7 weeks (8 weeks max)

  7. Number of daily steps, measured by a smartwatch paired with an iPhone.

    Time frame: 1 week and 7 weeks (8 weeks max)

  8. Changes in the number of calories burned per day Calories burned per day, are measured by a smartwatch paired with an iPhone.

    Time frame: 1 week and 7 weeks (8 maximum)

  9. Number of hospitalizations since the V1 visit

    Time frame: 3 weeks and 7 weeks (8 maximum)

  10. Change of residence since the V1 visit (Yes or No)

    Time frame: 3 weeks and 7 weeks (8 maximum)

  11. Changes in functional abilities measured by "Activities of Daily Living" (ADL) score (6 items)

    Time frame: baseline and 7 weeks (8 weeks maximum)

    _ /6 ; 0 being the worse and 6 the better

  12. Death (Yes or No)

    Time frame: 3 weeks and 7 weeks (8 maximum)

  13. Program adherence is measured by the number of completed self-rehabilitation sessions for Intervention Group

    Time frame: 7 weeks (8 weeks maximum)

  14. Changes in SPPB score, at V1 and V3 Short Physical Performance Battery (SPPB) score

    Time frame: 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.

  15. Number of falls showing signs of severity

    Time frame: 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 ?

  16. Changes in functional abilities measured by Instrumental Activity of Daily Living (IADL) score (4 items)

    Time frame: baseline and 7 weeks (8 weeks maximum)

    _ /4; 0 being the worse and 4 the better

Study contacts

Contact information is provided by the study sponsor or research team.

DRCI Promotion Interne

CONTACT

[email protected]

Issam BILAL, MS

CONTACT

[email protected]

02.41.35.68.28 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Acronym: DigiWalk

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 3, 2026
Registry last updated
Aug 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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