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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04580849
Other study ID # TELEDANCE
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 5, 2020
Est. completion date December 5, 2020

Study information

Verified date April 2021
Source Federal University of Health Science of Porto Alegre
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to verify the feasibility of a telerehabilitation approach with dance in people with parkinson's disease.


Description:

This is a feasibility study that aims to investigate the safety and efficacy of dance classes via an online platform in people with and without Parkinson's Disease. The intervention will last 2 months and the classes will be conducted twice a week (60 minutes) using the Zoom platform. Evaluations will be performed before and after the intervention by means of the Zoom platform as well and will include questionnaires of quality of life, depression, anxiety, and activities of daily living.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date December 5, 2020
Est. primary completion date October 5, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 45 Years and older
Eligibility Inclusion Criteria: - Individuals with and without parkinson's disease according London Brain Bank Criteria - Minimal cognitive ability to understand commands (MMSE) - Able to stand at least 10 minutes with or without support - Dopamine medication stable at least 6 weeks before the beginning of the study - Portable device and internet connection Exclusion Criteria: - Severe visual or auditive disturbances - Neurological disease (other than parkinson's for those included) or severe neuromuscular disorders that prejudice the proposed activities

Study Design


Related Conditions & MeSH terms


Intervention

Other:
telerehabilitation with dance
Dance classes will be provided through a online platform. Each class will last 60 minutes, twice a week, during 8 weeks.

Locations

Country Name City State
Brazil Universidade Federal de Ciências da Saúde de Porto Alegre Porto Alegre Rio Grande Do Sul

Sponsors (1)

Lead Sponsor Collaborator
Federal University of Health Science of Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary feasibility (adherence rates) To assess the feasibility of the study design and procedures. The adherence rate will be calculated by the total number of patients who completed the full course of intervention divided by the total number of patients included at the beginning. 10 weeks
Secondary feasibility (patients opinions) Semi structured interviews will involve gaining patients opinions on the strengths and weaknesses of the intervention 10 weeks
Secondary feasibility (safety and usability) The researches will follow all patients during the intervention regarding safety (i.e. falls) and usability (i.e. internet connection) 10 weeks
Secondary Parkinson's Disease Questionnaire-8 (PDQ-8) The PDQ-8 is a short-form version to assess quality of life in persons with Parkinson's disease. Each question is scored from 0-4 points and the scores are summed and given as a percentage score (0-100). The higher the score, the worse the patient's condition. Change from Pre to Post treatment (10 weeks)
Secondary 36-Item Short Form Survey (SF-36) The SF-36 measures health-related quality of life. This questionnaire has 36-item measure divided into 8 subscales - each subscale can be used independently. Each of the 8 summed scores is transformed into a scale from 0 (negative health) to 100 (positive health) Change from Pre to Post treatment (10 weeks)
Secondary Hospital Anxiety and Depression Scale (HADS) The scale is used to identify depression and anxiety and presents 14 items. The total score is out of 42. The higher scores indicate greater levels of anxiety and depression. Change from Pre to Post treatment (10 weeks)
Secondary Unified Parkinson's Disease Rating Scale (UPDRS) Part I The Part I concerns about non-motor experiences of daily living (e.g. anxiety and depression). This scale has 13 questions and all items have 5 response options. Higher scores indicate greater impact of PD symptoms. Change from Pre to Post treatment (10 weeks)
Secondary Activities-Specific Balance (ABC) Scale Self-reported questionnaire measuring self-efficacy in performing activities without losing balance. The ABC Scale consists of 16 questions that require the patient to rate their confidence on a scale from 0% to 100%. The higher the percentage, the higher level of physical functioning. Change from Pre to Post treatment (10 weeks)
Secondary Five Times Sit to Stand Test (FTSTS) The test assess the functional mobility strength of lower extremity (measured by the time to complete the test). The higher the time to complete the test, the lower the performance. Change from Pre to Post treatment (10 weeks)
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