AgingDigiWalkNCT07741994
Changes in Spatiotemporal Gait Parameters During a Digitally Assisted Self-rehabilitation Program for Elderly Fallers ( DigiWalk )
A study testing PFPP Group in people with Aging and Fall, run by University Hospital, Angers.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Aging, Fall, Fall Accident
- What is being tested?
- PFPP Group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 5 Dec 2026to 22 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
DRCI Promotion Interne contact
About this study
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.
Read the detailed description
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
- Conditions
- Aging, Fall, Fall Accident
- Being tested
- PFPP Group, Control Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PFPP GroupOther
Digitally assisted self-rehabilitation program in addition to standard care using Personalized Fall Prevention Program (PFPP) through the Stand'hop app.
Control GroupOther
Standard rehabilitation care
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Sham comparator | Not described Receives: Other: Control Group |
| Intervention Group | Active comparator | Not described Receives: Other: PFPP Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking speed (km/h).
Walking speed (km/h). Spatiotemporal gait parameters as measured using GAITRite®
Measured: 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®
Measured: 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®
Measured: 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®
Measured: this outcome is assessed at baseline and 7 weeks (8 weeks maximum)
Secondary outcomes (16)
Number of falls
Measured: baseline, 3 weeks and 7 weeks (8 maximum)
Gait stability measured by a smartwatch paired with an iPhone (in percentage)
Apple Healthkiit / appleWalkingSteadiness : Samples that match the Walking Steadiness identifier use percentage units (described in HKUnit)
Measured: 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.
Measured: 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.
Measured: 1 week and 7 weeks (8 weeks max)
Time spent standing (minutes), measured by a smartwatch paired with an iPhone.
Measured: 1 week and 7 weeks (8 weeks max)
Maximal oxygen consumption (VO₂max), measured by a smartwatch paired with an iPhone.
Measured: 1 week and 7 weeks (8 weeks max)
Number of daily steps, measured by a smartwatch paired with an iPhone.
Measured: 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.
Measured: 1 week and 7 weeks (8 maximum)
Number of hospitalizations since the V1 visit
Measured: 3 weeks and 7 weeks (8 maximum)
Change of residence since the V1 visit (Yes or No)
Measured: 3 weeks and 7 weeks (8 maximum)
Changes in functional abilities measured by "Activities of Daily Living" (ADL) score (6 items)
_ /6 ; 0 being the worse and 6 the better
Measured: baseline and 7 weeks (8 weeks maximum)
Death (Yes or No)
Measured: 3 weeks and 7 weeks (8 maximum)
Program adherence is measured by the number of completed self-rehabilitation sessions for Intervention Group
Measured: 7 weeks (8 weeks maximum)
Changes in SPPB score, at V1 and V3 Short Physical Performance Battery (SPPB) score
_/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.
Measured: baseline and 7 weeks (8 weeks maximum)
Number of falls showing signs of severity
If at least one fall met the criteria for severity, how many falls show signs of severity ?
Measured: baseline, 3 weeks and 7 weeks (8 maximum)
Changes in functional abilities measured by Instrumental Activity of Daily Living (IADL) score (4 items)
_ /4; 0 being the worse and 4 the better
Measured: baseline and 7 weeks (8 weeks maximum)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start5 Dec 2026 (estimated)
- Primary completion22 Jun 2028 (estimated)
- Study completion22 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Cédric ANNWEILER, Pr., Principal investigator, Angers Universitary Hospital (CHU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07741994
- Sponsor's protocol ID
- 49RC26_0272
- Other IDs
- 2026-A01541-50
- Acronym
- DigiWalk
- Status last verified
- Aug 2026
- First submitted
- 17 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Spatiotemporal Gait Parameters During a Digitally Assisted Self-rehabilitation Program for Elderly Fallers ( DigiWalk )
- ClinicalTrials.gov ID
- NCT07741994
- Acronym / sponsor ID
- DigiWalk / 49RC26_0272
- Conditions
- Aging, Fall, Fall Accident
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 5 Dec 2026 (estimated)
- Primary completion
- 22 Jun 2028 (estimated)
- Study completion
- 22 Jun 2028 (estimated)
- First posted
- 3 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Sham comparator | Other: Control Group |
| Intervention Group | Active comparator | Other: PFPP Group |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PFPP GroupDigitally assisted self-rehabilitation program in addition to standard care using Personalized Fall Prevention Program (PFPP) through the Stand'hop app. | Other | Intervention Group |
| Control GroupStandard rehabilitation care | Other | Control Group |
Primary outcome
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®
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)
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)
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)
16 secondary outcomes
Number of falls
Time frame: baseline, 3 weeks and 7 weeks (8 maximum)
Gait stability measured by a smartwatch paired with an iPhone (in percentage)
Time frame: 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.
Time frame: 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.
Time frame: 1 week and 7 weeks (8 weeks max)
Time spent standing (minutes), measured by a smartwatch paired with an iPhone.
Time frame: 1 week and 7 weeks (8 weeks max)
Maximal oxygen consumption (VO₂max), measured by a smartwatch paired with an iPhone.
Time frame: 1 week and 7 weeks (8 weeks max)
Number of daily steps, measured by a smartwatch paired with an iPhone.
Time frame: 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.
Time frame: 1 week and 7 weeks (8 maximum)
Number of hospitalizations since the V1 visit
Time frame: 3 weeks and 7 weeks (8 maximum)
Change of residence since the V1 visit (Yes or No)
Time frame: 3 weeks and 7 weeks (8 maximum)
Changes in functional abilities measured by "Activities of Daily Living" (ADL) score (6 items)
Time frame: baseline and 7 weeks (8 weeks maximum)
Death (Yes or No)
Time frame: 3 weeks and 7 weeks (8 maximum)
Program adherence is measured by the number of completed self-rehabilitation sessions for Intervention Group
Time frame: 7 weeks (8 weeks maximum)
Changes in SPPB score, at V1 and V3 Short Physical Performance Battery (SPPB) score
Time frame: baseline and 7 weeks (8 weeks maximum)
Number of falls showing signs of severity
Time frame: baseline, 3 weeks and 7 weeks (8 maximum)
Changes in functional abilities measured by Instrumental Activity of Daily Living (IADL) score (4 items)
Time frame: baseline and 7 weeks (8 weeks maximum)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
DRCI Promotion Interne contact
Cédric ANNWEILER, Pr. principal investigator
Angers Universitary Hospital (CHU)
Questions about this trial
What is this clinical trial studying?
A study testing PFPP Group in people with Aging and Fall, run by University Hospital, Angers.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Issam BILAL, MS (02.41.35.68.28 ext. +33, Issam.Bilal@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking speed (km/h). (time frame: this outcome is assessed at baseline and 7 weeks (8 weeks maximum)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026; AzTrials last refreshed its copy on 29 Oct 2026.