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Study of the Effect of a Cognitive Task on Static Balance in Depressive Elderly Subjects According to the Double Task Principle (DOUBLE TACHE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01950754
Recruitment Status : Unknown
Verified September 2013 by Centre Hospitalier Universitaire Dijon.
Recruitment status was:  Recruiting
First Posted : September 25, 2013
Last Update Posted : September 25, 2013
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Brief 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. Finally, it could contribute to improving the sensory-motor management of patients with a depressive syndrome.

Condition or disease Intervention/treatment Phase
Depression 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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Study of the Effect of a Cognitive Task on Static Balance in Depressive Elderly Subjects According to the Double Task Principle
Estimated Primary Completion Date : October 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
depressive patients 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 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



Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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,
  • 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

Exclusion Criteria:

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,
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01950754


Contacts
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Contact: Patrick MANCKOUNDIA 03.80.29.39.70 patrick.manckoundia@chu-dijon.fr

Locations
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France
CHU Dijon Recruiting
Dijon, France, 21000
Contact: Patrick MANCKOUNDIA    03.80.29.39.70    patrick.manckoundia@chu-dijon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT01950754    
Other Study ID Numbers: MANCKOUNDIA PHRC IR 2007
First Posted: September 25, 2013    Key Record Dates
Last Update Posted: September 25, 2013
Last Verified: September 2013
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms