- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05084287
Robot-assisted and Connected 6-minute Walk Test (TM6)
March 28, 2023 updated by: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
Evaluation of the reliability of the PEPPER robot in assisting and recording the parameters of a TM6.
Patients referred to the EFRED service for the performance of a 6MWT will be assisted during their test by the PEPPER robot.
The PEPPER robot will also collect the parameters of the 6MWT and produce a report.
The EFRED service technician will remain present during the 6MWT and will take note of the test parameters.
An evaluation of patient satisfaction with the assistance of the Robot Pepper in the realization of the 6MWT will also be carried out.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Anticipated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Paris, France
- Recruiting
- AP HP
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
- Patients referred for 6MWT to the EFRED department of the Pitié Salpêtrière hospital.
Description
Inclusion Criteria:
- >18 years
- Speak fluent French.
Exclusion Criteria:
- Patient's refusal to participate in the study
- Language barrier
- Cognitive disorders.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
6MWT parameters Robot vs Technician
Time Frame: 1 day
|
Measurement of the distance traveled by the patient compared to the measurement made by the medical technician
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2021
Primary Completion (Anticipated)
October 1, 2023
Study Completion (Anticipated)
December 1, 2023
Study Registration Dates
First Submitted
October 4, 2021
First Submitted That Met QC Criteria
October 18, 2021
First Posted (Actual)
October 19, 2021
Study Record Updates
Last Update Posted (Actual)
March 29, 2023
Last Update Submitted That Met QC Criteria
March 28, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PEPPER
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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