Study of Static and Dynamic Posturographic Elements Predictive of Falls in the Institutionalized Elderly

NCT05171036 | Unknown DMC

• 1 other identifier: ID-RCB 2017-A02545-48
• Study Type: interventional
• Target: 348
• Locations: 0 countries
• Sites: N/A

Brief 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". 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.

Conditions

Fall; Aging; Gait, Unsteady; Motor Activity

Outcome Measures

Primary Outcomes (1)

• 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.

  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".

  Every 6 months

• Correlation of fall risk indicators with other recorded variables

  Every 6 months

Other Outcomes (1)

• Acceptability of the measure system

  At 24 months

Study Arms (1)

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

Other: Adapted Physical Activity

Interventions

Adapted Physical Activity OTHER

* 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.

Institutionalized elderly people undergoing adapted physical activity

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• Exit from the trial by resident's choice ;

Sponsors & Collaborators

• Centre Borelli UMR 9010: lead

Related Publications (3)

• 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.

  PMID: 34713067 BACKGROUND

• 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.

  PMID: 32565327 BACKGROUND

• 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.

  PMID: 32235667 BACKGROUND

MeSH Terms

Conditions

Gait Disorders, Neurologic; Motor Activity

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Flavien QUIJOUX, PhD

  Orpea Group

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Flavien Quijoux, PhD

CONTACT

+33604528356; flquijoux@gmail.com

Francois Bertin-Hugault, MD

CONTACT

f.bertin-hugault@orpea.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2021
• First Posted: December 28, 2021
• Study Start: January 17, 2022
• Primary Completion: February 28, 2022
• Study Completion: December 1, 2023
• Last Updated: December 28, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: 2021 - Publication of the Protocole 2022 - Publication of the preliminary results 2023/24 - Publication of the final results