Study of Static and Dynamic Posturographic Elements Predictive of Falls in the Institutionalized Elderly
NCT ID: NCT05171036
Last Updated: 2021-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
348 participants
INTERVENTIONAL
2022-01-17
2023-12-01
Brief Summary
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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
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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
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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Institutionalized elderly people undergoing adapted physical activity
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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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;
* Having signed the informed consent.
* 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.
Exclusion Criteria
* 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.
65 Years
ALL
Yes
Sponsors
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Centre Borelli UMR 9010
NETWORK
Responsible Party
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Principal Investigators
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Flavien QUIJOUX, PhD
Role: PRINCIPAL_INVESTIGATOR
Orpea Group
Central Contacts
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References
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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.
Quijoux 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.
Dot 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.
Other Identifiers
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ID-RCB 2017-A02545-48
Identifier Type: -
Identifier Source: org_study_id