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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06348186
Other study ID # Fascial Tissue Response
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2024
Est. completion date July 31, 2024

Study information

Verified date April 2024
Source University of the State of Santa Catarina
Contact Larissa Sinhorim
Phone 47984057340
Email larissasinhorim@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

According to the World Health Organization (WHO), as of mid-September 2022, more than 21 million Brazilians have recovered from COVID-19. However, post-infection symptoms continue to appear months after the end of the acute infection, a syndrome called long COVID. Therefore, the aim of this study is to investigate the responses of fascia-focused manual therapy in participants with long COVID.


Description:

Participants reported to have long COVID, of both sexes, aged between 20 and 80 years, from the community, outpatient clinics and hospitals will be evaluated. The treatment of participants will be carried out at the CEFID-UDESC Physiotherapy School Clinic, where they will undergo assessment of the biomechanical and viscoelastic properties of tissues, postural control, pain and quality of life. For normality analysis, the Shapiro-Wilk test will be applied, and according to the distribution of the data, parametric or non-parametric tests will be used. Pre- and post-assessment and treatment data will be compared using descriptive statistics and Student's t-test with a significance level of p=0.05 for parametric data or Wilcoxon for non-parametric data.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date July 31, 2024
Est. primary completion date April 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria: - Participants diagnosed with long COVID, of both sexes, aged between 20 and 80 years, from the community, outpatient clinics and hospitals. Exclusion Criteria: - Participants with suspected deep vein thrombosis; Participants with neurological disorders.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Guidebook
Folder that will be given to the participant to carry out 5 minutes of intervention daily
Guidebook and Myofascial Reorganization® (RMF).
The intervention will be carried out once a week for 30 minutes for 6 weeks. It will include passive, active-assisted moments (with and without load). In addition to a folder that will be given to the participant to carry out 5 minutes of intervention daily.

Locations

Country Name City State
Brazil Santa Catarina State University Florianópolis Santa Catarina

Sponsors (2)

Lead Sponsor Collaborator
University of the State of Santa Catarina Larissa Sinhorim

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Functioning and disability Will be assessed using the "World Health Organization Disability Assessment" questionnaire (WHO-DAS 2.0), translated and validated for the Brazilian population by Silveira et al. (2013). 6 weeks
Primary Biomechanical and tissue viscoelastic properties Will be evaluated by MyotonPro (MytonPro, Myoton Ltd.s., Tartu, Estonia) 6 weeks
Secondary Work capacity Will be assessed by the "Work Limitations Questionnaire, WLQ-25" translated and validated for the Brazilian population by Soárez et al (2007). 6 weeks
Secondary Quality of life Will be assessed by the "World Health Organization Questionnaire" in its short version (WHOQOL-bref), validated in the Brazilian population by Fleck et al (2000), and by the "Medical Outcomes Study 36-Item Short Form Health" questionnaire Survey" (SF-36), validated for Brazilian-Portuguese by Ciconelli et al (1999). 6 weeks
Secondary Upper limb dysfunctions Will be assessed using the Arm, Shoulder and Hand Dysfunctions questionnaire (DASH), translated and validated for the Brazilian population by Orfale et al (2005). 6 weeks
Secondary Balance Will be assessed using the Neurocom Balance Platform (VRS Sport) and its NeuroCom®Balance Manager program (Neurocom International, Inc, Clackamas, OR). 6 weeks
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