FallPOSTADYCHUTENCT05171036
Study of Static and Dynamic Posturographic Elements Predictive of Falls in the Institutionalized Elderly
A study testing Adapted Physical Activity in people with Fall and Aging, run by Centre Borelli UMR 9010.
Trial summary
A fall in the elderly is defined by the WHO as "an event in which a person [over 65 years of age] inadvertently falls to a lower level on the ground or other surface than they were previously at". Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fall, Aging, Gait, Unsteady
- What is being tested?
- Adapted Physical Activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 348 participants
- Where
- No sites listed yet
- Study dates
- 17 Jan 2022to 1 Dec 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Adult subjects of both sexes, aged 65 and over, with social insurance;
- Residing in an ORPEA Group retirement home;
- Do not have a neurological, inner ear or visual disorder that is incompatible with climbing on the force platform or walking 10 metres round trip without human assistance;
- Can safely climb onto the platform by force (as estimated by the investigating practitioner) and can maintain an erect position for more than 1 minute, with eyes open or closed;
- Had an MMSE score of more than 18 on the nursing home entrance examination;
- Having a life expectancy of more than 6 months, as estimated by the coordinating doctor;
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- Having signed the informed consent.
- Non-inclusion Criteria:
- Non-mobile resident: any person with a musculoskeletal or neurosensory disorder that does not allow them to stand for more than 1 minute on the power platform;
- History of limb amputation;
- Blindness, assessed using an Amsler grid;
- Refusal of the resident.
Who cannot join
- Exit from the trial by resident's choice ;
- Inability of the resident to continue with static and dynamic assessments (e.g. due to a serious adverse event following a fall) The study is an intention-to-treat study and data from participants who do not complete the protocol will be used until the date of their exclusion from the trial or their death.
Trial locations and contacts
No sites are listed yet.
Francois Bertin-Hugault, MD contact
About this study
Official title: Etude Des éléments Posturographiques Statiques et Dynamiques prédictifs de la Chute de la Personne âgée institutionnalisée
A fall in the elderly is defined by the WHO as "an event in which a person [over 65 years of age] inadvertently falls to a lower level on the ground or other surface than they were previously at". The severity of the consequences of falls is correlated with the age of the person who suffers them, making people over 65 at risk. Since 2000, the number of falls among the elderly has not decreased, including in institutions. Today, the direct and indirect costs of falls are estimated at 1.7 billion euros in France.
The French National Authority for Health (HAS) stresses that the lack of success of prevention policies is due in particular to the lack of evaluation and prevention resources. In nursing homes, this lack of resources is sometimes used to justify passive restraint to ensure the safety of participants. However, this method poses the problem of the free movement of residents within the institution. The fall detection technologies already on the market do not allow for the assessment of the risk of falling and therefore for early action.
Based on the latest scientific data in static posturography, researchers at the Borelli Centre have developed posturographic markers whose non-linear analysis makes it possible to establish an objective and clinically relevant score based on the study of the displacement of the centre of pressure. In contrast to the techniques commonly used in the laboratory to study balance (which are not usable in health care institutions because of their cost, lack of transportability and the expertise required to explore the recorded data), this method of measurement allows health care professionals to quickly and easily measure the balance of participants in routine consultations. Thus, special attention and targeted rehabilitation can then be implemented to prevent falls and their consequences.
Read the detailed description
Since 2000, the number of falls among the elderly has not decreased, even in institutions. The HAS stresses that the lack of success of prevention policies is due in particular to the lack of means of evaluation and prevention. Based on the latest scientific data in static posturography, researchers at the UMRD Cognac-G have developed posturographic markers whose non-linear analysis makes it possible to establish an objective and clinically relevant score for analysing the risk of falls in EHPAD residents. This measurement method, patented [FR1660846; FR1660850; FR1557582; FR1770031] and published [Oudre, 2015; Audiffren, 2016; Barrois, 2017; Bargiotas, 2018], allows health professionals to quickly assess the balance of participants in routine consultations.
According to the WHO, falls are the consequence of many multidimensional factors. Adapted physical activity can have a beneficial effect on these factors, particularly in terms of reducing risk behaviours, modifying the environment and improving physiological capacities. If the results of the study prove to be relevant, in the long term, measurements based on the Borelli Centre's method of measuring balance in EHPAD could be recommended. It could thus help doctors in the early management of balance disorders in institutionalized elderly people.
The main objective of this Postadychute-AG study is to quantify and monitor the risk of falls in the elderly on a monthly basis by validating the relevance of the patented indicators and their analysis, which are obtained from a statokinesigram recorded on a force platform and data from inertial units measuring the movements of body segments, predicting the risk of falling. This will be done by comparing the predicted risk of falling with the number of falls actually recorded each month of follow-up of institutionalized seniors undergoing adapted physical activity (APA). Our secondary objectives are also to :
- To study the sensitivity of our model to the natural evolution of nursing home residents during a 3-month observation period without APA and to the improvement of their condition with APA sessions in addition to routine care
- To assess the acceptability of the measurement method and the use of the fall score through the scale developed for this purpose among nursing home staff.
- If the results of the study prove to be relevant, the ultimate aim is to recommend that measurements be taken using the measurement method used in this study. It will thus be able to help doctors in their diagnosis and early management of balance disorders by teams of rehabilitation specialists.
- Conditions
- Fall, Aging, Gait, Unsteady, Motor Activity
- Being tested
- Adapted Physical Activity
- Medical subject headings
- Gait Disorders, Neurologic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted Physical ActivityOther
- Group 1 Maintenance of autonomy: "Patients in group 1 have no cardiovascular disorders, possibly some cognitive deficits but do not reside in a protected unit.
- Group 2 Prevention of the risk of falls: "Patients in group 2 have no cardiovascular problems, possibly some cognitive problems, but can finally follow the indications of the cognitive assessment in the form developped for the study.
- Group 3 Prevention of the risk of falls and monitoring of cardiovascular disorders in the absence of cognitive impairment: "Patients in group 3 have had a recent, and currently stabilised, cardiovascular event that may justify exercise reconditioning.
- Group 4 Prevention of the risk of falls and disorientation in a context of cognitive deficit: "Patients in group 4 have moderate to severe cognitive disorders, or have Alzheimer's disease or a related disease at a stage of the disease requiring special attention.
| Study group | Role | What they receive |
|---|---|---|
| Institutionalized elderly people undergoing adapted physical activity | Experimental | 2h/week for 3 months (i.e. 24 sessions), after 3 months of no-APA for gait and balance baseline recordings, with the rehabilitation team in place in the establishments, around the 4 specific programmes Receives: Other: Adapted Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive value of indicators measured monthly over the 6 months of follow-up
Predictive value of indicators measured monthly over the 6 months of follow-up (3 months without ABS followed by 3 months with ABS). The predictive value will be quantified by an evaluation of the threshold of the predictive score out of 100, based on a minimum sensitivity of 80% and a maximum specificity (the Youden index is the numerical criterion), via an ROC curve and a measurement of the area under the curve (AUC) for the classification between "at high risk of falling" and "at low risk of falling" (binary criterion). This classification is subsequently verified by means of the falls collection sheets and the falls history at the next visit.
Measured: Every 6 months
Secondary outcomes (2)
Positive (PPV) and Negative (NPV) predictive values based on the binary classification "high risk of falling" and "low risk of falling".
As with the AUC, PPV and NPV will be calculated on the basis of the questionnaires and the falls form recorded each month. This method has been used previously to assess the predictive qualities of clinical tests.
Measured: Every 6 months
Correlation of fall risk indicators with other recorded variables
A value of more than 0.7 and a significance of the correlation test will be considered as indicating a strong correlation between the predictive score on the one hand and falls in the institution or the clinical course of the participants on the other.
Measured: Every 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2021
- Study start17 Jan 2022 (estimated)
- Primary completion28 Feb 2022 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for FallStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 348 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Borelli UMR 9010
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Flavien QUIJOUX, PhD, Principal investigator, Orpea Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05171036
- Sponsor's protocol ID
- ID-RCB 2017-A02545-48
- Acronym
- POSTADYCHUTE
- Status last verified
- Dec 2021
- First submitted
- 25 Nov 2021
- Last updated
- 28 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The clinical trial data will be aggregated and presented as averages by group and subgroup in order to comply with the regulatory authorities in the treatment of so-called sensitive data, particularly in relation to the health and identity of the persons involved in the research. Scientific publications concerning the protocols, methods of analysis of the data used and the results of the study will be submitted to peer-reviewed journals and/or code-sharing platforms to promote reproducible and transparent science.
Publications
Quijoux F, Bertin-Hugault F, Zawieja P, Lefevre M, Vidal PP, Ricard D. Postadychute-AG, Detection, and Prevention of the Risk of Falling Among Elderly People in Nursing Homes: Protocol of a Multicentre and Prospective Intervention Study. Front Digit Health. 2021 Jan 27;2:604552. doi: 10.3389/fdgth.2020.604552. eCollection 2020.
PubMed 34713067Quijoux F, Vienne-Jumeau A, Bertin-Hugault F, Zawieja P, Lefevre M, Vidal PP, Ricard D. Center of pressure displacement characteristics differentiate fall risk in older people: A systematic review with meta-analysis. Ageing Res Rev. 2020 Sep;62:101117. doi: 10.1016/j.arr.2020.101117. Epub 2020 Jun 19.
PubMed 32565327Dot T, Quijoux F, Oudre L, Vienne-Jumeau A, Moreau A, Vidal PP, Ricard D. Non-Linear Template-Based Approach for the Study of Locomotion. Sensors (Basel). 2020 Mar 30;20(7):1939. doi: 10.3390/s20071939.
PubMed 32235667
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etude Des éléments Posturographiques Statiques et Dynamiques prédictifs de la Chute de la Personne âgée institutionnalisée
- ClinicalTrials.gov ID
- NCT05171036
- Acronym / sponsor ID
- POSTADYCHUTE / ID-RCB 2017-A02545-48
- Conditions
- Fall, Aging, Gait, Unsteady, Motor Activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 348 participants (estimated)
- Lead sponsor
- Centre Borelli UMR 9010Research network
- Study start
- 17 Jan 2022 (estimated)
- Primary completion
- 28 Feb 2022 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 28 Dec 2021 (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.
A fall in the elderly is defined by the WHO as "an event in which a person [over 65 years of age] inadvertently falls to a lower level on the ground or other surface than they were previously at". The severity of the consequences of falls is correlated with the age of the person who suffers them, making people over 65 at risk. Since 2000, the number of falls among the elderly has not decreased, including in institutions. Today, the direct and indirect costs of falls are estimated at 1.7 billion euros in France.
The French National Authority for Health (HAS) stresses that the lack of success of prevention policies is due in particular to the lack of evaluation and prevention resources. In nursing homes, this lack of resources is sometimes used to justify passive restraint to ensure the safety of participants. However, this method poses the problem of the free movement of residents within the institution. The fall detection technologies already on the market do not allow for the assessment of the risk of falling and therefore for early action.
Based on the latest scientific data in static posturography, researchers at the Borelli Centre have developed posturographic markers whose non-linear analysis makes it possible to establish an objective and clinically relevant score based on the study of the displacement of the centre of pressure. In contrast to the techniques commonly used in the laboratory to study balance (which are not usable in health care institutions because of their cost, lack of transportability and the expertise required to explore the recorded data), this method of measurement allows health care professionals to quickly and easily measure the balance of participants in routine consultations. Thus, special attention and targeted rehabilitation can then be implemented to prevent falls and their consequences.
Detailed description
Since 2000, the number of falls among the elderly has not decreased, even in institutions. The HAS stresses that the lack of success of prevention policies is due in particular to the lack of means of evaluation and prevention. Based on the latest scientific data in static posturography, researchers at the UMRD Cognac-G have developed posturographic markers whose non-linear analysis makes it possible to establish an objective and clinically relevant score for analysing the risk of falls in EHPAD residents. This measurement method, patented [FR1660846; FR1660850; FR1557582; FR1770031] and published [Oudre, 2015; Audiffren, 2016; Barrois, 2017; Bargiotas, 2018], allows health professionals to quickly assess the balance of participants in routine consultations.
According to the WHO, falls are the consequence of many multidimensional factors. Adapted physical activity can have a beneficial effect on these factors, particularly in terms of reducing risk behaviours, modifying the environment and improving physiological capacities. If the results of the study prove to be relevant, in the long term, measurements based on the Borelli Centre's method of measuring balance in EHPAD could be recommended. It could thus help doctors in the early management of balance disorders in institutionalized elderly people.
The main objective of this Postadychute-AG study is to quantify and monitor the risk of falls in the elderly on a monthly basis by validating the relevance of the patented indicators and their analysis, which are obtained from a statokinesigram recorded on a force platform and data from inertial units measuring the movements of body segments, predicting the risk of falling. This will be done by comparing the predicted risk of falling with the number of falls actually recorded each month of follow-up of institutionalized seniors undergoing adapted physical activity (APA). Our secondary objectives are also to :
- To study the sensitivity of our model to the natural evolution of nursing home residents during a 3-month observation period without APA and to the improvement of their condition with APA sessions in addition to routine care
- To assess the acceptability of the measurement method and the use of the fall score through the scale developed for this purpose among nursing home staff.
- If the results of the study prove to be relevant, the ultimate aim is to recommend that measurements be taken using the measurement method used in this study. It will thus be able to help doctors in their diagnosis and early management of balance disorders by teams of rehabilitation specialists.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Institutionalized elderly people undergoing adapted physical activity | Experimental | Other: Adapted Physical Activity2h/week for 3 months (i.e. 24 sessions), after 3 months of no-APA for gait and balance baseline recordings, with the rehabilitation team in place in the establishments, around the 4 specific programmes |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (12 listed)
- Adult subjects of both sexes, aged 65 and over, with social insurance;
- Residing in an ORPEA Group retirement home;
- Do not have a neurological, inner ear or visual disorder that is incompatible with climbing on the force platform or walking 10 metres round trip without human assistance;
- Can safely climb onto the platform by force (as estimated by the investigating practitioner) and can maintain an erect position for more than 1 minute, with eyes open or closed;
- Had an MMSE score of more than 18 on the nursing home entrance examination;
Key exclusion criteria (2 listed)
- Exit from the trial by resident's choice ;
- Inability of the resident to continue with static and dynamic assessments (e.g. due to a serious adverse event following a fall) The study is an intention-to-treat study and data from participants who do not complete the protocol will be used until the date of their exclusion from the trial or their death.
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 |
|---|---|---|
| Adapted Physical Activity* Group 1 Maintenance of autonomy: "Patients in group 1 have no cardiovascular disorders, possibly some cognitive deficits but do not reside in a protected unit. * Group 2 Prevention of the risk of falls: "Patients in group 2 have no cardiovascular problems, possibly some cognitive problems, but can finally follow the indications of the cognitive assessment in the form developped for the study. * Group 3 Prevention of the risk of falls and monitoring of cardiovascular disorders in the absence of cognitive impairment: "Patients in group 3 have had a recent, and currently stabilised, cardiovascular event that may justify exercise reconditioning. * Group 4 Prevention of the risk of falls and disorientation in a context of cognitive deficit: "Patients in group 4 have moderate to severe cognitive disorders, or have Alzheimer's disease or a related disease at a stage of the disease requiring special attention. | Other | Institutionalized elderly people undergoing adapted physical activity |
Primary outcome
Predictive value of indicators measured monthly over the 6 months of follow-up
Time frame: Every 6 months
Predictive value of indicators measured monthly over the 6 months of follow-up (3 months without ABS followed by 3 months with ABS). The predictive value will be quantified by an evaluation of the threshold of the predictive score out of 100, based on a minimum sensitivity of 80% and a maximum specificity (the Youden index is the numerical criterion), via an ROC curve and a measurement of the area under the curve (AUC) for the classification between "at high risk of falling" and "at low risk of falling" (binary criterion). This classification is subsequently verified by means of the falls collection sheets and the falls history at the next visit.
2 secondary outcomes
Positive (PPV) and Negative (NPV) predictive values based on the binary classification "high risk of falling" and "low risk of falling".
Time frame: Every 6 months
Correlation of fall risk indicators with other recorded variables
Time frame: Every 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2021.
- Background: PubMed 34713067Quijoux F, Bertin-Hugault F, Zawieja P, Lefevre M, Vidal PP, Ricard D. Postadychute-AG, Detection, and Prevention of the Risk of Falling Among Elderly People in Nursing Homes: Protocol of a Multicentre and Prospective Intervention Study. Front Digit Health. 2021 Jan 27;2:604552. doi: 10.3389/fdgth.2020.604552. eCollection 2020.
- Background: PubMed 32565327Quijoux F, Vienne-Jumeau A, Bertin-Hugault F, Zawieja P, Lefevre M, Vidal PP, Ricard D. Center of pressure displacement characteristics differentiate fall risk in older people: A systematic review with meta-analysis. Ageing Res Rev. 2020 Sep;62:101117. doi: 10.1016/j.arr.2020.101117. Epub 2020 Jun 19.
- Background: PubMed 32235667Dot T, Quijoux F, Oudre L, Vienne-Jumeau A, Moreau A, Vidal PP, Ricard D. Non-Linear Template-Based Approach for the Study of Locomotion. Sensors (Basel). 2020 Mar 30;20(7):1939. doi: 10.3390/s20071939.
- Individual participant dataSharing planned: Yes. The clinical trial data will be aggregated and presented as averages by group and subgroup in order to comply with the regulatory authorities in the treatment of so-called sensitive data, particularly in relation to the health and identity of the persons involved in the research. Scientific publications concerning the protocols, methods of analysis of the data used and the results of the study will be submitted to peer-reviewed journals and/or code-sharing platforms to promote reproducible and transparent science.
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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.
Francois Bertin-Hugault, MD contact
Flavien QUIJOUX, PhD principal investigator
Orpea Group
Questions about this trial
What is this clinical trial studying?
A study testing Adapted Physical Activity in people with Fall and Aging, run by Centre Borelli UMR 9010.
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 12 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: status not confirmed, as of the sponsor's last update on 28 Dec 2021. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Flavien Quijoux, PhD (+33604528356, flquijoux@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive value of indicators measured monthly over the 6 months of follow-up (time frame: Every 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05171036, which also lists 3 linked publications.
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 28 Dec 2021.