Elderly PatientsDOKTORBRAUNCT03800771
DOuble tasK Test On ergometeR - Basic Research on Acceptability and Use
A study testing Cycléo BRAU and GAITRITE® in people with Elderly Patients, run by University Hospital, Angers at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Elderly Patients
- What is being tested?
- Cycléo BRAU and GAITRITE®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 28 Aug 2019to 17 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Elderly Patients
- Being tested
- Cycléo BRAU, GAITRITE®
- Keywords
- geriatric, dual-task, ergometer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cycléo BRAUDevice
Practice dual-task tests.
GAITRITE®Device
Routine practice dual-task tests.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Cycléo BRAU; Device: GAITRITE® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speed
Evaluate the concordance of the speed during the tests on treadmill and on cyclo-ergometer.
Measured: 12 months
Speed variability
Evaluate the concordance the speed variability during the tests on treadmill and on cyclo-ergometer.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study start28 Aug 2019
- Primary completion17 May 2021
- Study completion17 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elderly PatientsStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Pierre ABRAHAM, MD; PhD, Principal investigator, University Hospital in Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03800771
- Sponsor's protocol ID
- 2018-A01109-46
- Acronym
- DOKTORBRAU
- Status last verified
- Jun 2022
- First submitted
- 20 Dec 2018
- Last updated
- 24 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DOuble tasK Test On ergometeR - Basic Research on Acceptability and Use
- ClinicalTrials.gov ID
- NCT03800771
- Acronym / sponsor ID
- DOKTORBRAU / 2018-A01109-46
- Conditions
- Elderly Patients
- Keywords
- geriatric, dual-task, ergometer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 28 Aug 2019 (actual)
- Primary completion
- 17 May 2021 (actual)
- Study completion
- 17 May 2022 (actual)
- First posted
- 11 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Practice dual-task tests | Experimental | Device: Cycléo BRAU, Device: GAITRITE®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). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cycléo BRAUPractice dual-task tests. | Device | Practice dual-task tests |
| GAITRITE®Routine practice dual-task tests. | Device | Practice dual-task tests |
Primary outcome
Speed
Time frame: 12 months
Evaluate the concordance of the speed during the tests on treadmill and on cyclo-ergometer.
Speed variability
Time frame: 12 months
Evaluate the concordance the speed variability during the tests on treadmill and on cyclo-ergometer.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre ABRAHAM, MD; PhD principal investigator
University Hospital in Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cycléo BRAU and GAITRITE® in people with Elderly Patients, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speed (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2022.