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

February 20, 2024 updated by: Centre Hospitalier Universitaire Dijon
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Dijon, France, 21000
        • CHU Dijon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
up to 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2008

Primary Completion (Actual)

May 14, 2013

Study Registration Dates

First Submitted

September 23, 2013

First Submitted That Met QC Criteria

September 24, 2013

First Posted (Estimated)

September 25, 2013

Study Record Updates

Last Update Posted (Estimated)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 20, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MANCKOUNDIA PHRC IR 2007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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