Study Accelerometer Signals to Measure Daily Activities (SASMDA)

This study has been completed.
Sponsor:
Collaborators:
TIMC-IMAG
Laboratory TIMA
Clinical Investigation Centre for Innovative Technology Network
Information provided by (Responsible Party):
AdministrateurCIC, University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01617512
First received: December 15, 2011
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

The purpose of this study is to determine if it is possible to identify activities in the daily accelerometer measures of a person with urinary disorders.


Condition Intervention
Urinary Disorders
Device: LIS302DL accelerometer

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Study Accelerometer Signals to Measure Daily Activities: a Pilot Study

Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • Number of patients with urinary disorders for which it is possible to identify automatically activities among all the daily accelerometer data. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Intrinsic characteristics (sensitivity, specificity, ROC curve) of the test for detecting in automated way the activities among all the daily accelerometer data


Secondary Outcome Measures:
  • Score of satisfaction with the use of the medical device, assessed by the patients [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Score between 0 and 10, takes into account the feasibility of the proposed approach and the patient felt the importance of this feasibility.


Enrollment: 30
Study Start Date: February 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: LIS302DL accelerometer
    Recording for 24 hours accelerations related to daily physical activity of the patient.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • man
  • patients fitted with artificial urinary sphincter
  • patients affiliated to social security or similar regime

Exclusion Criteria:

  • patient do not speak french
  • patient unable to express his consent
  • patient hospitalize without consent
  • patient under legal protection
  • patient deprived of liberty
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01617512

Locations
France
University Hospital
Grenoble, France
Sponsors and Collaborators
AdministrateurCIC
TIMC-IMAG
Laboratory TIMA
Clinical Investigation Centre for Innovative Technology Network
Investigators
Principal Investigator: Alexandre Moreau-gaudry, MD, PhD CHU Grenoble
  More Information

Additional Information:
No publications provided

Responsible Party: AdministrateurCIC, principal investigator, University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01617512     History of Changes
Other Study ID Numbers: DCIC 1116
Study First Received: December 15, 2011
Last Updated: April 10, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

ClinicalTrials.gov processed this record on August 28, 2014