MOBility Disorders Assessment in Patients With Mild COGnitive Disorders

NCT05273125 | Recruiting

• 2 other identifiers: 2020_552021-A00637-34
• Study Type: observational
• Target: 417
• Locations: 1 country
• Sites: 2

Brief Summary

Mild cognitive impairment (MCI) is defined by lower performance in one or more cognitive domains with preservation of independence in functional abilities. Sixteen percent of community-dwelling older people (over 65 years) live with MCI. They are both cognitively and physically vulnerable. From a cognitive perspective, they are susceptible to converting to the dementia stage at an annual rate of 10%. From a physical perspective, the proportion of slow gait or neurological gait abnormalities can reach 46% in the population with MCI. Falls in turn increase the risk of accelerated cognitive decline and the risk of institutionalization. In the absence of a curative treatment for dementia, it is essential to have an effective and personalized prevention strategy by identifying the predictive factors for falls in this at-risk population with MCI. The research goals of this project are 1) to identify specific predictors for falls in clinic attendees with MCI in preparation for a definitive, fully powered study across France, and 2) to demonstrate the feasibility of a pragmatic fall risk assessment in MCs, whatever its setting and location. We aim to prospectively follow-up people diagnosed with MCI and aged above 65 years old in four MCs in France (three in the North (one community-based MC), and one in the Centre) for one year.

Conditions

Cognitive Dysfunction

Keywords

Mild Cognitive Impairement; Falls; Predictive factors; Elderly; Gait disorders assessment.

Outcome Measures

Primary Outcomes (1)

• Existence of at least one fall

  The primary objective is to identify factors predictive of having at least one fall at one year First, the relationship between each candidate risk factor (independent variables) and the presence of at least one fall at one year (binary dependent variable) will be studied by bivariate logistic regression models. For quantitative candidate factors, the log-linearity assumption of the logistic regression model will be tested using cubic spline functions, which models the non-linear effect. The 10 pre-selected factors will be included in a multivariate logistic regression model, regardless of the outcome of the bi-variate analyses. The multivariate analysis will be performed following the recommendations of Peduzzi et al on the number of variables to include in a multivariate model (10 events per estimated parameter).

  12 months

Secondary Outcomes (6)

• Comparison between the fall schedule given and kept by the patient and / or his main caregiver and the collection of anamnestic data on the occurrence of falls

  6 months and 12 months

• Patients enrollment rate

  12 months

• Satisfaction rate of caregivers assessed by a specific questionnaire (Likert)

  12 months

• Rate of multifallers allowing the comparison of the same variables as those used for the main objective between fallers, non-fallers and multifallers

  12 months

• Rate of serious falls allowing the comparison of the same variables in the subgroup of patients who had had at least one serious fall

  12 months

Interventions

Gait disorders and falls risk assessment BEHAVIORAL

Implementation of a standardized assessment of the fall risk and gait disorders in the memory clinic in addition to usual care.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

elderly patients with MCI followed in memory centers

You may qualify if:

• Patient being diagnosed with MCI, according to the 2011 criteria
• Able to walk 4 meters with or without technical assistance
• Comprehension of French language allowing the realization of the neuropsychological assessment

You may not qualify if:

• Severe visual or hearing impairment that does not allow the assessment
• Severe pathology that makes follow-up impossible
• Administrative reasons: inability to receive informed information, inability to participate in the entire study, lack of social security insurance, refusal to sign consent form
• Under legal protection (guardianship, curatorship, safeguard of justice)

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (2)

Les Bateliers Chu Lille

Lille, 59037, France

RECRUITING

Hop Salengro - Hopital B

Lille, France

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Yaohua CHEN, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yaohua CHEN, MD

CONTACT

0320445962; Yaohua.chen@chru-lille.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: March 10, 2022
• Study Start: September 9, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 26, 2025

Record last verified: 2025-03

Locations

FR (2)