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NCT05084287 Clinical Trial

Robot-assisted and Connected 6-minute Walk Test (TM6)

Respiratory Insufficiency Clinical Trial

Official title:
Robot-assisted and Connected 6-minute Walk Test (TM6)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05084287
Other study ID # PEPPER
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2021
Est. completion date December 2023

Study information
Verified date March 2023
Source Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
Contact Valery TROSINY DESERT, MD
Phone +33.1.56.81.40.60
Email arc@antadir.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date December 2023
Est. primary completion date October 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - >18 years - Speak fluent French. Exclusion Criteria: - Patient's refusal to participate in the study - Language barrier - Cognitive disorders.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France AP HP Paris

Sponsors (1)
Lead Sponsor Collaborator
Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 6MWT parameters Robot vs Technician Measurement of the distance traveled by the patient compared to the measurement made by the medical technician 1 day
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