Study Accelerometer Signals to Measure Daily Activities (SASMDA)

Urinary Disorders Clinical Trial

Official title:

Study Accelerometer Signals to Measure Daily Activities: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01617512
• Other study ID #: DCIC 1116
• Status: Completed
• Phase: N/A
• First received: December 15, 2011
• Last updated: April 10, 2014
• Start date: February 2012
• Est. completion date: July 2013

Study information

• Verified date: April 2014
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Urinary Disorders

Intervention

Device:
• LIS302DL accelerometer
Recording for 24 hours accelerations related to daily physical activity of the patient.

Locations

Country	Name	City	State
France	University Hospital	Grenoble

Sponsors (4)

Lead Sponsor	Collaborator
AdministrateurCIC	Clinical Investigation Centre for Innovative Technology Network, Laboratory TIMA, TIMC-IMAG

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with urinary disorders for which it is possible to identify automatically activities among all the daily accelerometer data.	Intrinsic characteristics (sensitivity, specificity, ROC curve) of the test for detecting in automated way the activities among all the daily accelerometer data	6 months	No
Secondary	Score of satisfaction with the use of the medical device, assessed by the patients	Score between 0 and 10, takes into account the feasibility of the proposed approach and the patient felt the importance of this feasibility.	6 months	No

External Links

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