CClinicalTrials.gg
CompletedNCT01617512Updated Apr 11, 2014

Study Accelerometer Signals to Measure Daily Activities (SASMDA)

An interventional study of LIS302DL accelerometer in Urinary Disorders, sponsored by AdministrateurCIC. Completed at 1 site in France. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-04-11.

Sponsored by AdministrateurCIC · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
Male
01

Study 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.

02

Conditions studied

  • Urinary Disorders
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Interventions

  • DeviceLIS302DL accelerometer

    Recording for 24 hours accelerations related to daily physical activity of the patient.

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: 6 months

Secondary outcomes

  1. 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.

    Time frame: 6 months

06

Study locations

1 site
  • University Hospital
    Grenoble, France
07

Registry details

Key details

Study ID
NCT01617512
Lead sponsor
AdministrateurCIC
Collaborators
TIMC-IMAG, Laboratory TIMA, Clinical Investigation Centre for Innovative Technology Network
Responsible party
AdministrateurCIC (principal investigator, University Hospital, Grenoble) — Sponsor-investigator
First posted
Jun 12, 2012
Start date
Feb 2012
Primary completion
Jul 2013
Completion
Jul 2013
Last update
Apr 11, 2014

Study contacts

Alexandre Moreau-gaudry, MD, PhD
principal investigator · University Hospital, Grenoble

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion