Towards the Use of Instrumented Tests for Screening the Risk of Falling in Patients With Chronic Illness.

NCT04368858 | Completed

• 2 other identifiers: RBHP 2020 REYNAUD2020-A00290-39
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

In patients with chronic illness, screening for falls and their health consequences are major public health issues. Muscle weakness, gait and balance disorders are among the most common risk factors for falling. Assessing these parameters would thus be a crucial step in the evaluation of the risk of falling, allowing to more precisely orient the management strategy. Combining inertial unit sensors with clinically validated tests can provide additional information to improve the assessment of fall risks. We therefore propose to constitute a monocentric exploratory study, testing a prognostic screening tool, in patients suffering from a chronic pathology, in order to assess the risk of falling in this population. Considering the relationship between muscle weakness and the risk of falling, we can assume that a deficit in muscle strength will result in less vertical acceleration which could point to a muscle cause of the balance disorder and thus allow a finer detection of the risk of falling. On the other hand, we hypothesize that spinal static disorders in chronic pathologies and in particular osteoarthritis, as well as balance disorders linked to impaired deep sensitivity lead to an increase in oscillations of the trunk when walking which can cause postural balance disorders thus increasing the risk of falling.

Conditions

Joint Osteoarthritis; Atherosclerosis of the Distal Arteries, Without Gangrene; Parkinson Disease; Chronic Obstructive Pulmonary Disease, Unspecified; Obesity, Unspecified

Keywords

Inertial sensors; Timed Up and Go test; 6-Minute Walk test; Fall; Risk of fall; Altered mobility; Chronic illness; Chronic pathologies; Physical capacities; Physical test; Activity limitations

Outcome Measures

Primary Outcomes (2)

• Vertical acceleration in m/s² during the sit to stand phase of the Timed-Up and Go test.

  Vertical acceleration will be collected with the mTUG® inertial sensor unit.

  Day 0

• Maximum voluntary isokinetic strength (Nm) of the quadriceps muscles in slow speed (60°/s) concentric contraction.

  : Maximum voluntary isokinetic strength of the quadriceps muscles will be measured with the HUMA® /NORM™ device.

  Day 0

Secondary Outcomes (54)

• Demographics information

  day 0

• Weight (Kg).

  day 0

• Height (cm).

  day 0

• Waist circumference (cm).

  day 0

• Hip circumference (cm).

  day 0

Study Arms (1)

Cohort 1 : experimental group

EXPERIMENTAL

Participants will be involved in an evaluation program combining, body composition measures, physical tests as well as self-administered questionnaires. Participants will be followed for 1 year with evaluations (occurrence of fall) taking place at 6 months and at 1 year.

Diagnostic Test: Exploratory physiopathology study, including non-invasive functional explorations carried out in patients with chronic pathology.

Interventions

Exploratory physiopathology study, including non-invasive functional explorations carried out in patients with chronic pathology. DIAGNOSTIC_TEST

In the Mobility Exploration Unit of the University Hospital of Clermont-Ferrand, patients with chronic illnesses undergo a complete assessment of their physical capacities as well as their nutritional status. For the purpose of this protocol, patients will have to perform 2 functional tests, namely the TM6 and the TUG, while being equipped with inertial sensor units (mTUG® and mGAIT®). The data of the gait analysis, posturography and strength analyses as well as the questionnaires' scores will be taken into account in this research. At 6 months and at 1 year, occurrence of a fall will be recorded in order to prospectively monitor this parameter.

Cohort 1 : experimental group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Man or woman aged 18 to 90.
• Patients with chronic pathology contributing to impaired mobility.
• Volunteers who have given their written consent.
• Affiliated to French health care system (for France)

You may not qualify if:

• Patients suffering from progressive psychiatric pathologies (active psychosis, hallucinations, etc.) or the presence of another serious unstabilized pathology (decompensated heart failure, progressive terminal cancer, etc.).
• People with poorly controlled or unstable cardiovascular disease.
• Major osteoarticular or neurological problems completely preventing the proper performance of the various tests.
• Persons under guardianship, curatorship, deprived of liberty or safeguarding justice.
• People refusing to participate.
• Pregnant or lactating women.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

Chu Clermont Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

Parkinson Disease; Pulmonary Disease, Chronic Obstructive; Obesity; Chronic Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Study Officials

• Emmanuel COUDEYRE

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: April 30, 2020
• Study Start: August 28, 2020
• Primary Completion: November 16, 2022
• Study Completion: November 16, 2022
• Last Updated: November 21, 2022

Record last verified: 2022-11

Locations

FR (1)