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Completed

NCT Number: NCT03800771

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

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.

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Key information

Conditions

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Angers

Angers, 49933, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cycléo BRAU

Device

Practice dual-task tests.

GAITRITE®

Device

Routine practice dual-task tests.

Primary outcomes

  1. Speed

    Time frame: 12 months

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

  2. Speed variability

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Acronym: DOKTORBRAU

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Jan 11, 2019
Registry last updated
Jun 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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