Risk of Falling in the ElderlyPARACHUTENCT06535477
Fall Risk Assessment With an Innovative Device for Quantifying Gait and Static Balance in Geriatric Consultation
A study testing Fall risk assessment in people with Risk of Falling in the Elderly, run by Gérond'if at 1 site in France.
Trial summary
The main objective of this monocentric, non-randomized, prospective study was to evaluate the predictive capacity of a balance score based on spatio-temporal parameters of postural balance. Read more about this study
- Who is it for?
- Ages 65 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Risk of Falling in the Elderly
- What is being tested?
- Fall risk assessment
- Type of treatment
- Medical device
- How many people
- 169 participants
- Where
- 1 siteFrance
- Study dates
- 26 Jul 2024to 26 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 95 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Subject with a "Autonomie, Gérontologie, Groupes IsoRessources" (GIR) score ≥ 4 at the time of consultation
- Subject presenting an The mini mental status exam (MMSE) score ≥ 18 at the time of consultation
- Subject agreeing in writing (consent), after having been informed and given a reasonable period of reflection, to participate in the study
- Subject affiliated to a social security scheme.
Who cannot join
- Subjects with a major or systemic pathology likely to significantly impair motor skills (inability to perform a 10m walking test without assistance, inability to perform a balance test on a scale without assistance (30 seconds eyes open / 30 seconds eyes closed),
- Subject with an advanced neurodegenerative pathology (Alzheimer, Parkinson, etc.) deemed incompatible with the objectives of the study by the investigator,
- Subjects with a history of disabling cerebrovascular accident,
- Subject with an active disabling cancer,
- Subjects with severe psychiatric disorders affecting their ability to perform walking and balance tests and/or answer study questionnaires,
- Subjects benefiting from a technical aid for walking and balance such as a cane, walker, etc. (only orthopedic insoles and shoes are accepted); subjects with a total hip or knee prosthesis are included,
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- Subject having been hospitalized for a fall in the last 3 months prior to inclusion,
- Subject unable to understand the purpose of the research, answer questions and give his/her decision to participate in the study,
- Subject already included in another research study involving the human body,
- Subject not affiliated to a social security scheme or not benefiting from such a scheme.
- Person deprived of liberty by judicial or administrative decision
- Person of full age subject to a legal protection measure (guardianship, curatorship, safeguard of justice) or unable to express consent.
Trial locations and contacts
1 site in 1 country.
France1 site
Ambulatory Care Department, Charles Foix Hospital
Ivry-sur-Seine, IIe-de-France, 94200
About this study
The main objective of this monocentric, non-randomized, prospective study was to evaluate the predictive capacity of a balance score based on spatio-temporal parameters of postural balance.
Read the detailed description
Patient recruitment will take place at one center. The inclusion period is 6 months and the participation period for each subject will be 12 months with 3 visits: initial visit, telephone visit at 6 months, M12 consultation visit, and the end-of-study visit.
Consent will be obtained prior to participation, and the following data will be collected during the visits: Demographic data (age, gender), weight, height, geriatric assessment. Current treatment (molecules, date of introduction, dosage). Biological data: Albumin, Pre-Albumin, Creatinine, Hemoglobin, Vitamin D.
Static balance parameters via AbilyCare (static balance test, inspired by the Romberg test, on a balance platform, 30 seconds eyes open then 30 seconds eyes closed).
The total duration of the research is 18 months.
- Conditions
- Risk of Falling in the Elderly
- Being tested
- Fall risk assessment
- Keywords
- Falls, static balance, Spatio temporal parameters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fall risk assessmentDevice
Assessing frailty in elderly patients using Fried Frailty and "Short Emergency Geriatric Assessment" scales combined with measurement - via the AbilyCare device - of the two markers of balance and gait
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance score
The balance score, based on a learning model incorporating spatio-temporal parameters of pressure center displacement. These parameters include amplitude along the anterior-posterior and medio-lateral axes, surface area covered, and displacement speed. The overall score is calculated on the basis of model-building data from profiles of people with and without previous falls. This score, evaluated from 0 to 100, indicates the level of balance, with a score of 99 representing optimal balance. The lower the score, the more precarious the balance, thus approximating a potential faller profile.
Measured: 12 months
Secondary outcomes (1)
Evaluation of the association between each static balance indicator and fall occurrence
The following indicators will be analyzed:
- Oscillation area in mm² : Area covered by the displacement of the center of pressure, calculated by tracing the trajectory of the center of pressure and determining the minimum area that encompasses all these trajectories (contained within an ellipse of 90% confidence).
- Sway density in seconds : Duration (travel time) during the entire sequence (30s) when the center of pressure remains in the vicinity (radius less than 5 mm) of each calculated point of the center of pressure's position.
- Lateral variance in mm² : Extent of variability in the position of the center of pressure around an average position on the medial-lateral axis.
- Average oscillation speed in mm/s : Average speed of displacement of the center of pressure in all directions.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start26 Jul 2024
- Primary completion26 Feb 2026
- Study completion26 Feb 2026
Why it stopped: Liquidation judiciaire de la société partenaire AbilyCare ayant développé le dispositif médical utilisé dans le cadre de cette étude.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk of Falling in the ElderlyStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Assessing frailty in elderly patients using Fried Frailty and "Short Emergency Geriatric Assessment" scales combined with measurement - via the AbilyCare device - of the two markers of balance and gait
- Masking
- None (open label)
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gérond'if
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvie Pariel, MD, Study chair, Ambulatory Care Department, Charles Foix HospitalLina MICHELET, MD, Study director, Abilycare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06535477
- Sponsor's protocol ID
- 2024-A00055-42
- Acronym
- PARACHUTE
- Status last verified
- Apr 2026
- First submitted
- 24 Jun 2024
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fall Risk Assessment With an Innovative Device for Quantifying Gait and Static Balance in Geriatric Consultation
- ClinicalTrials.gov ID
- NCT06535477
- Acronym / sponsor ID
- PARACHUTE / 2024-A00055-42
- Conditions
- Risk of Falling in the Elderly
- Keywords
- Falls, static balance, Spatio temporal parameters
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Liquidation judiciaire de la société partenaire AbilyCare ayant développé le dispositif médical utilisé dans le cadre de cette étude.
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Gérond'ifUniversity, hospital or other
- Study start
- 26 Jul 2024 (actual)
- Primary completion
- 26 Feb 2026 (actual)
- Study completion
- 26 Feb 2026 (actual)
- First posted
- 2 Aug 2024 (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.
The main objective of this monocentric, non-randomized, prospective study was to evaluate the predictive capacity of a balance score based on spatio-temporal parameters of postural balance.
Detailed description
Patient recruitment will take place at one center. The inclusion period is 6 months and the participation period for each subject will be 12 months with 3 visits: initial visit, telephone visit at 6 months, M12 consultation visit, and the end-of-study visit.
Consent will be obtained prior to participation, and the following data will be collected during the visits: Demographic data (age, gender), weight, height, geriatric assessment. Current treatment (molecules, date of introduction, dosage). Biological data: Albumin, Pre-Albumin, Creatinine, Hemoglobin, Vitamin D.
Static balance parameters via AbilyCare (static balance test, inspired by the Romberg test, on a balance platform, 30 seconds eyes open then 30 seconds eyes closed).
The total duration of the research is 18 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- Assessing frailty in elderly patients using Fried Frailty and "Short Emergency Geriatric Assessment" scales combined with measurement - via the AbilyCare device - of the two markers of balance and gait
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Subject with a "Autonomie, Gérontologie, Groupes IsoRessources" (GIR) score ≥ 4 at the time of consultation
- Subject presenting an The mini mental status exam (MMSE) score ≥ 18 at the time of consultation
- Subject agreeing in writing (consent), after having been informed and given a reasonable period of reflection, to participate in the study
- Subject affiliated to a social security scheme.
Key exclusion criteria (12 listed)
- Subjects with a major or systemic pathology likely to significantly impair motor skills (inability to perform a 10m walking test without assistance, inability to perform a balance test on a scale without assistance (30 seconds eyes open / 30 seconds eyes closed),
- Subject with an advanced neurodegenerative pathology (Alzheimer, Parkinson, etc.) deemed incompatible with the objectives of the study by the investigator,
- Subjects with a history of disabling cerebrovascular accident,
- Subject with an active disabling cancer,
- Subjects with severe psychiatric disorders affecting their ability to perform walking and balance tests and/or answer study questionnaires,
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 |
|---|---|---|
| Fall risk assessmentAssessing frailty in elderly patients using Fried Frailty and "Short Emergency Geriatric Assessment" scales combined with measurement - via the AbilyCare device - of the two markers of balance and gait | Device | – |
Primary outcome
Balance score
Time frame: 12 months
The balance score, based on a learning model incorporating spatio-temporal parameters of pressure center displacement. These parameters include amplitude along the anterior-posterior and medio-lateral axes, surface area covered, and displacement speed. The overall score is calculated on the basis of model-building data from profiles of people with and without previous falls. This score, evaluated from 0 to 100, indicates the level of balance, with a score of 99 representing optimal balance. The lower the score, the more precarious the balance, thus approximating a potential faller profile.
1 secondary outcome
Evaluation of the association between each static balance indicator and fall occurrence
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Liquidation judiciaire de la société partenaire AbilyCare ayant développé le dispositif médical utilisé dans le cadre de cette étude.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 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. This study is not recruiting at the moment.
Sylvie Pariel, MD study chair
Ambulatory Care Department, Charles Foix Hospital
Lina MICHELET, MD study director
Abilycare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fall risk assessment in people with Risk of Falling in the Elderly, run by Gérond'if at 1 site in France.
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 4 inclusion and 12 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: stopped early, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study was stopped early (reason given: Liquidation judiciaire de la société partenaire AbilyCare ayant développé le dispositif médical utilisé dans le cadre de cette étude.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance score (time frame: 12 months). 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 29 Apr 2026.