NCT01950754

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 20, 2008

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 14, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2013

Completed
Last Updated

February 21, 2024

Status Verified

February 1, 2024

Enrollment Period

5 years

First QC Date

September 23, 2013

Last Update Submit

February 20, 2024

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

  • the difference in distance traveled by moving the center of pressure between the simple task and the dual task

    up to 2 months

Study Arms (2)

depressive patients

OTHER
Behavioral: standing with both feetBehavioral: descent of the platformBehavioral: standing on the platform, feet together and always with simultaneous performance of a task of mental count

nondepressed controls

OTHER
Behavioral: standing with both feetBehavioral: descent of the platformBehavioral: standing on the platform, feet together and always with simultaneous performance of a task of mental count

Interventions

standing with both feetBEHAVIORAL
depressive patientsnondepressed controls
descent of the platformBEHAVIORAL
depressive patientsnondepressed controls
standing on the platform, feet together and always with simultaneous performance of a task of mental countBEHAVIORAL
depressive patientsnondepressed controls

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Dijon

Dijon, 21000, France

Location

MeSH Terms

Conditions

Depression

Interventions

Standing Position

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2013

First Posted

September 25, 2013

Study Start

May 20, 2008

Primary Completion

May 14, 2013

Last Updated

February 21, 2024

Record last verified: 2024-02

Locations

FR(1)