- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04580849
Telerehabilitation Using a Dance Intervention in People With Parkinson's Disease
April 5, 2021 updated by: Aline de Souza Pagnussat, Federal University of Health Science of Porto Alegre
The aim of this study is to verify the feasibility of a telerehabilitation approach with dance in people with parkinson's disease.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
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
-
-
Rio Grande Do Sul
-
Porto Alegre, Rio Grande Do Sul, Brazil, 90050-170
- Universidade Federal de Ciências da Saúde de Porto Alegre
-
-
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
45 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 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
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: telerehabilitation with dance (Parkinson's)
This group will receive dance classes online during 60 minutes, twice a week for 8 weeks.
|
Dance classes will be provided through a online platform.
Each class will last 60 minutes, twice a week, during 8 weeks.
|
Active Comparator: telerehabilitation with dance (Healthy controls)
This group will receive dance classes online during 60 minutes, twice a week for 8 weeks.
|
Dance classes will be provided through a online platform.
Each class will last 60 minutes, twice a week, during 8 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
feasibility (adherence rates)
Time Frame: 10 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
feasibility (patients opinions)
Time Frame: 10 weeks
|
Semi structured interviews will involve gaining patients opinions on the strengths and weaknesses of the intervention
|
10 weeks
|
feasibility (safety and usability)
Time Frame: 10 weeks
|
The researches will follow all patients during the intervention regarding safety (i.e.
falls) and usability (i.e.
internet connection)
|
10 weeks
|
Parkinson's Disease Questionnaire-8 (PDQ-8)
Time Frame: Change from Pre to Post treatment (10 weeks)
|
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)
|
36-Item Short Form Survey (SF-36)
Time Frame: Change from Pre to Post treatment (10 weeks)
|
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)
|
Hospital Anxiety and Depression Scale (HADS)
Time Frame: Change from Pre to Post treatment (10 weeks)
|
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)
|
Unified Parkinson's Disease Rating Scale (UPDRS) Part I
Time Frame: Change from Pre to Post treatment (10 weeks)
|
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)
|
Activities-Specific Balance (ABC) Scale
Time Frame: Change from Pre to Post treatment (10 weeks)
|
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)
|
Five Times Sit to Stand Test (FTSTS)
Time Frame: Change from Pre to Post treatment (10 weeks)
|
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)
|
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)
September 5, 2020
Primary Completion (Actual)
October 5, 2020
Study Completion (Actual)
December 5, 2020
Study Registration Dates
First Submitted
October 1, 2020
First Submitted That Met QC Criteria
October 7, 2020
First Posted (Actual)
October 9, 2020
Study Record Updates
Last Update Posted (Actual)
April 6, 2021
Last Update Submitted That Met QC Criteria
April 5, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TELEDANCE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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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