Clinical trial NCT03800771: DOuble tasK Test On ergometeR - Basic Research on Acceptability and Use
Official title: DOuble tasK Test On ergometeR - Basic Research on Acceptability and Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly Patients
Keywords: geriatric
dual-task
ergometer
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2019-01-11
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients are inhomogeneous in term of cognitive and physical function. The aim is to test faisability and security thus investigator will include a relatively large amount of patients.
Primary purpose: OTHER

Brief summary: The goal of the study is to show the concordance between the dual-task test achieved usually on an electronic treadmill and the dual-task test achieved with a cyclo-ergometer.

Detailed description: Usually, dual task tests are only achieved on electronic treadmills. Patients who are coming to perform these tests are mainly subjects with various levels of cognitive disorders and with a high risk of fall because of potential motor and cognitive disorders.

The investigator will select patients referred for double task walking tests. After the walking test, investigator will perform dual-task tests with a new bicycle device "Cycléo BRAU" which allows the patients to achieve mental tasks while cycling. The aim of using a bicycle is to limit the risk of falls compared to the treadmill or walking task. The "Cycléo BRAU" device is equiped with a video projector which projects an environment of virtual reality. It allows cycling without resistence and thus is not based on any incremental worload. The mental tasks on bicycle will be of increasing difficulty and parameters such as cycling speed will be recorded. Loss of speed regularity will be considered as an abnormal response. The task for which cycling is stopped will be recorded and compared to the results of the usual walking test.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 60 years old
* Patient with a near visual acuity upper or equal to 2/10
* Patient with a score of MMSE upper than 10
* Patient able to walk on a treadmill for 15 meters on straight line without help
* Patient covered by the French health insurance
* Patient (or support person or legal representative) able to understand the protocol
* Patient (or support person or legal representative) agrees to be involve in the protocol and sign the consent form

Exclusion Criteria:

* Patient has a wash-out period for another clinical trial
* Patient with a medical contraindication to practice bicycle
* Patient with locomotor disorders preexisting, whatever the reason
* Patient needing extern help to walk like a walking frame, rollator or tricycle
* Patient with a medical or surgical disease acute from less of 3 months
* Patient with cerebrovascular accident history or any other cerebro-medullary diseases with sensorimotor consequences
* Patient with severe depression (Geriatric Depression Scale 15 items upper than 10)
* Patient with a low proficiency of French (oral or written)

Primary outcomes:
measure: Speed
timeFrame: 12 months
measure: Speed variability
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
Study officials:
affiliation: University Hospital in Angers
name: Pierre ABRAHAM, MD; PhD
role: PRINCIPAL_INVESTIGATOR
References: