DOuble tasK Test On ergometeR - Basic Research on Acceptability and Use

NCT03800771 | Completed

• 1 other identifier: 2018-A01109-46
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Elderly Patients

Keywords

geriatric; dual-task; ergometer

Outcome Measures

Primary Outcomes (2)

• Speed

  Evaluate the concordance of the speed during the tests on treadmill and on cyclo-ergometer.

  12 months

• Speed variability

  Evaluate the concordance the speed variability during the tests on treadmill and on cyclo-ergometer.

  12 months

Study Arms (1)

Practice dual-task tests

EXPERIMENTAL

The study consists to practice these dual-task tests with a new device which name is "Cycléo BRAU" that allows to the patients to achieve carefully an attentional task: cycle. Results will be compared tothe results obsvered during the routine GAITRITE analysis ( a validated tool for elderly patients and gait analysis).

Device: Cycléo BRAU; Device: GAITRITE®

Interventions

Cycléo BRAU DEVICE

Practice dual-task tests.

Practice dual-task tests

GAITRITE® DEVICE

Routine practice dual-task tests.

Practice dual-task tests

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

CHU Angers

Angers, 49933, France

Location

Study Officials

• Pierre ABRAHAM, MD; PhD

  University Hospital in Angers

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: 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.

Study Record Dates

• First Submitted: December 20, 2018
• First Posted: January 11, 2019
• Study Start: August 28, 2019
• Primary Completion: May 17, 2021
• Study Completion: May 17, 2022
• Last Updated: June 24, 2022

Record last verified: 2022-06

Locations

FR (1)