Study Accelerometer Signals to Measure Daily Activities (SASMDA)

Not Applicable

Completed

• Conditions: Urinary Disorders

• Registration Number: NCT01617512
• Lead Sponsor: AdministrateurCIC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-15
• Study Start: 2012-02
• Study First Submitted QC: 2012-06-11
• Study First Posted: 2012-06-12
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-10
• Last Update Posted: 2014-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of patients with urinary disorders for which it is possible to identify automatically activities among all the daily accelerometer data.	6 months	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

Name	Time	Method
Score of satisfaction with the use of the medical device, assessed by the patients	6 months	Score between 0 and 10, takes into account the feasibility of the proposed approach and the patient felt the importance of this feasibility.

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Grenoble, France