Study Accelerometer Signals to Measure Daily Activities (SASMDA)
This study is currently recruiting participants.
Verified February 2013 by University Hospital, Grenoble
Sponsor:
AdministrateurCIC
Collaborators:
TIMC-IMAG
Laboratory TIMA
Clinical investigation center, Technological innovation
Information provided by (Responsible Party):
AdministrateurCIC, University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01617512
First received: December 15, 2011
Last updated: February 1, 2013
Last verified: February 2013
| Tracking Information | |||||||||
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| First Received Date ICMJE | December 15, 2011 | ||||||||
| Last Updated Date | February 1, 2013 | ||||||||
| Start Date ICMJE | February 2012 | ||||||||
| Estimated Primary Completion Date | October 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01617512 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Study Accelerometer Signals to Measure Daily Activities (SASMDA) | ||||||||
| Official Title ICMJE | Study Accelerometer Signals to Measure Daily Activities: a Pilot Study | ||||||||
| 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
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| Condition ICMJE | Urinary Disorders | ||||||||
| Intervention ICMJE | Device: LIS302DL accelerometer
Recording for 24 hours accelerations related to daily physical activity of the patient. |
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| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 12 | ||||||||
| Estimated Completion Date | October 2013 | ||||||||
| Estimated Primary Completion Date | October 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | France | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01617512 | ||||||||
| Other Study ID Numbers ICMJE | DCIC 1116 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | AdministrateurCIC, University Hospital, Grenoble | ||||||||
| Study Sponsor ICMJE | AdministrateurCIC | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | University Hospital, Grenoble | ||||||||
| Verification Date | February 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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