NCT04754906

Brief Summary

Falling is an event that is more frequent and severe in older age. It can lead to a loss of autonomy and a decrease in quality of life. It is therefore important to understand this phenomenon in order to better prevent it. Among the multiple risk factors associated with falling, recent research has shown a link between the decline in cognitive abilities (i.e., the mental processes that form our knowledge, such as memory) and the risk of falling. However, the impact of this cognitive decline on motor skills is still poorly understood. The purpose of this research is to study how the changes induced by aging affect motor skills. This would make it possible to take a new look at the phenomenon of falls occurring in the elderly and, in the long term, to improve the prevention and rehabilitation.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
684

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Jan 2021Dec 2028

First Submitted

Initial submission to the registry

October 6, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

January 25, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 15, 2021

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

September 22, 2025

Status Verified

September 1, 2025

Enrollment Period

7.9 years

First QC Date

October 6, 2020

Last Update Submit

September 17, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Sequence 1: symmetry ratio of the finger speed profile

    through study completion, an average of 3 years

  • Sequence 2 : perception bias (error in degrees of angle) of dynamic subjective visual vericality

    through study completion, an average of 3 years

  • Sequence 3 : activation time of the focal muscles in relation to the postural muscles

    through study completion, an average of 3 years

Study Arms (3)

young neurotypical subjects

people from 18 to 40 years old

Other: Sequence 1Other: Sequence 2Other: Sequence 3

elderly neurotypical subjects

people over 55 years of age

Other: Sequence 1Other: Sequence 2Other: Sequence 3

Elderly subjects with mild cognitive impairment

people over 55 years of age, with a diagnosis of mild cognitive impairment

Other: Sequence 1Other: Sequence 2Other: Sequence 3

Interventions

perform arm movements towards a target

Elderly subjects with mild cognitive impairmentelderly neurotypical subjectsyoung neurotypical subjects

judge the verticality of an object

Elderly subjects with mild cognitive impairmentelderly neurotypical subjectsyoung neurotypical subjects

In standing position, point as quickly as possible with the right arm at the diode that will light up in front of the participant.

Elderly subjects with mild cognitive impairmentelderly neurotypical subjectsyoung neurotypical subjects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

young subjects, elderly neurotypical subjects and elderly subjects with mild cognitive disorder

You may qualify if:

  • Neurotypical subjects group:
  • Person aged 18 to 40 years
  • Person who has given oral consent
  • Affiliated to national health insurance
  • Right-handed person
  • Group of elderly neurotypical subjects:
  • Person over 55 years of age
  • Person who has given oral consent
  • Affiliated to national health insurance
  • No cognitive problems (MMSE score \>26)
  • Right-handed person
  • Elderly mild cognitive disorder subject group:
  • Person over 55 years of age
  • Person who has given oral consent
  • Diagnosis of Mild Cognitive Disorder made by a neurologist at the Centre Mémoire Ressources et Recherche (CMRR) of the University Hospital of Dijon, following the recommendations of the National Institute for Aging and Alzheimer's Association (Albert et al., 2011) This diagnosis is based on psychometric tests, brain imaging and the evolution of cognitive disorders, including an MMSE test.
  • +1 more criteria

You may not qualify if:

  • Neurological or psychiatric history with the exception of the TCL group.
  • Follow-up of drug treatment in the last three months that may affect cognitive and/or motor skills.
  • Received a shoulder prosthesis on the dominant side.
  • Received a hip and/or knee replacement less than a year ago.
  • Disabling joint disease of the hip or knee shoulder
  • Protected adults (curatorship, guardianship)
  • Person deprived of their liberty b judicial or administrative decision
  • Pregnant, parturient or breastfeeding woman
  • Major unable to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Dijon Bourgogne

Dijon, 21000, France

RECRUITING

MeSH Terms

Conditions

Neurocognitive Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2020

First Posted

February 15, 2021

Study Start

January 25, 2021

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

September 22, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations