DepressionDOUBLE TACHENCT01950754
Study of the Effect of a Cognitive Task on Static Balance in Depressive Elderly Subjects According to the Double Task Principle
A study testing standing with both feet, descent of the platform and standing on the platform, feet together and always with simultaneous performance of a task of mental count in people with Depression, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
This study could contribute to understanding the aggravation of balance disorders and the increased risk of falling in depressive people. It could, among other things, shed light on the impact of treatments with antidepressants on balance in treated depressive patients. Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- standing with both feet, descent of the platform and standing on the platform, feet together and always with simultaneous performance of a task of mental count
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 20 May 2008to 14 May 2013
- 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 75 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- In the 2 groups:
- General and cognitive status allowing the patient, according to the evaluation of the investigators, to take part in the study.
- Patients who provide written informed consent
- Patients covered by the national health insurance agency
- In the "depression " group:
- Age ≥ 75 years,
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- Subjects with a depressive syndrome, according to Geriatric Depression Scale criteria.
- Patients without treatment with antidepressants
- In the "control" group:
- Age ≥ 75 years,
- Absence of a depressive syndrome
Who cannot join
- In the 2 groups:
- Presence of a disabling orthopedic disease,
- Presence of any chronic neurological disease (cerebrovascular accident, Parkinson's syndrome …),
- Presence of a psychiatric disease apart from depression in the " depression " group
- Presence of a vestibular disease with clinical manifestations,
- Presence of a non-corrected visual disorder,
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- Existence of a progressive organ disease,
- Psychotropic treatment able to impair vigilance and posture,
- Notion of one or several falls in the preceding 6 months,
- Oppositional personality or low motivation,
- Emotional or intellectual disorder.
- Patients under guardianship
- Patients who have taken part in a therapeutic trial in the previous 30 days
Trial locations and contacts
1 site in 1 country.
About this study
This study could contribute to understanding the aggravation of balance disorders and the increased risk of falling in depressive people. It could, among other things, shed light on the impact of treatments with antidepressants on balance in treated depressive patients. Finally, it could contribute to improving the sensory-motor management of patients with a depressive syndrome.
- Conditions
- Depression
- Being tested
- standing with both feet, descent of the platform, standing on the platform, feet together and always with simultaneous performance of a task of mental count
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standing with both feetBehavioural
descent of the platformBehavioural
standing on the platform, feet together and always with simultaneous performance of a task of mental countBehavioural
| Study group | Role | What they receive |
|---|---|---|
| depressive patients | Other | Not described Receives: Behavioral: standing with both feet; Behavioral: descent of the platform; Behavioral: standing on the platform, feet together and always with simultaneous performance of a task of mental count |
| nondepressed controls | Other | Not described Receives: Behavioral: standing with both feet; Behavioral: descent of the platform; Behavioral: standing on the platform, feet together and always with simultaneous performance of a task of mental count |
What is being measured
The primary outcome is the main question the study is designed to answer.
the difference in distance traveled by moving the center of pressure between the simple task and the dual task
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2013 (estimated)
- Study start20 May 2008
- Primary completion14 May 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01950754
- Sponsor's protocol ID
- MANCKOUNDIA PHRC IR 2007
- Acronym
- DOUBLE TACHE
- Status last verified
- Feb 2024
- First submitted
- 23 Sep 2013
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effect of a Cognitive Task on Static Balance in Depressive Elderly Subjects According to the Double Task Principle
- ClinicalTrials.gov ID
- NCT01950754
- Acronym / sponsor ID
- DOUBLE TACHE / MANCKOUNDIA PHRC IR 2007
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 20 May 2008 (actual)
- Primary completion
- 14 May 2013 (actual)
- First posted
- 25 Sep 2013 (estimated)
- 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.
This study could contribute to understanding the aggravation of balance disorders and the increased risk of falling in depressive people. It could, among other things, shed light on the impact of treatments with antidepressants on balance in treated depressive patients. Finally, it could contribute to improving the sensory-motor management of patients with a depressive syndrome.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| depressive patients | Other | Behavioral: standing with both feet, Behavioral: descent of the platform, Behavioral: standing on the platform, feet together and always with simultaneous performance of a task of mental count |
| nondepressed controls | Other | Behavioral: standing with both feet, Behavioral: descent of the platform, Behavioral: standing on the platform, feet together and always with simultaneous performance of a task of mental count |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- General and cognitive status allowing the patient, according to the evaluation of the investigators, to take part in the study.
- Patients who provide written informed consent
- Patients covered by the national health insurance agency
- Age ≥ 75 years,
- Subjects with a depressive syndrome, according to Geriatric Depression Scale criteria.
Key exclusion criteria (13 listed)
- Presence of a disabling orthopedic disease,
- Presence of any chronic neurological disease (cerebrovascular accident, Parkinson's syndrome …),
- Presence of a psychiatric disease apart from depression in the " depression " group
- Presence of a vestibular disease with clinical manifestations,
- Presence of a non-corrected visual disorder,
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 |
|---|---|---|
| standing with both feet | Behavioural | depressive patients, nondepressed controls |
| descent of the platform | Behavioural | depressive patients, nondepressed controls |
| standing on the platform, feet together and always with simultaneous performance of a task of mental count | Behavioural | depressive patients, nondepressed controls |
Primary outcome
the difference in distance traveled by moving the center of pressure between the simple task and the dual task
Time frame: up to 2 months
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 21 Feb 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standing with both feet, descent of the platform and standing on the platform, feet together and always with simultaneous performance of a task of mental count in people with Depression, run by Centre Hospitalier Universitaire Dijon 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 11 inclusion and 13 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 21 Feb 2024. 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?
the difference in distance traveled by moving the center of pressure between the simple task and the dual task (time frame: up to 2 months). 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 21 Feb 2024; AzTrials last refreshed its copy on 1 Nov 2026.