Fitz, Fátima Faní
Gimenez, Márcia Maria
de Azevedo Ferreira, Letícia
Matias, Mayanni Magda Perreira
Bortolini, Maria Augusta Tezelli
Castro, Rodrigo Aquino
Article History
Received: 19 May 2020
Accepted: 9 July 2021
First Online: 23 July 2021
Declarations
:
: This study has been evaluated and approved by Research Ethical Board of the <i>Universidade Federal de São Paulo</i> (UNIFESP), Brazil (2.263.749). The Informed consent for each participant is obtained during the onsite eligibility evaluation by the evaluator. The participants will have time to consider and ask the evaluator questions before giving consent. No safety monitoring committees are needed for this trial because the interventions had a low level of risk to patient safety. However, participant safety will be monitored by the steering committee (composed of the trial’s investigators) and monitored independently by the local ethics committees. The physical therapist is responsible for sending partial reports (every 6 months), and the final report, when the study is completed, to the Research Ethical Board of the UNIFESP.
: Not applicable.
: The authors report no conflict of interest.