Parkinson DiseaseNCT04580849
Telerehabilitation Using a Dance Intervention in People With Parkinson's Disease
A study testing telerehabilitation with dance in people with Parkinson Disease, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
Trial summary
The aim of this study is to verify the feasibility of a telerehabilitation approach with dance in people with parkinson's disease. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- telerehabilitation with dance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Sep 2020to 5 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Severe visual or auditive disturbances
- Neurological disease (other than parkinson's for those included) or severe neuromuscular disorders that prejudice the proposed activities
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal de Ciências da Saúde de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90050-170
About this study
The aim of this study is to verify the feasibility of a telerehabilitation approach with dance in people with parkinson's disease.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- telerehabilitation with dance
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telerehabilitation with danceOther
Dance classes will be provided through a online platform. Each class will last 60 minutes, twice a week, during 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| telerehabilitation with dance (Parkinson's) | Experimental | This group will receive dance classes online during 60 minutes, twice a week for 8 weeks. Receives: Other: telerehabilitation with dance |
| telerehabilitation with dance (Healthy controls) | Active comparator | This group will receive dance classes online during 60 minutes, twice a week for 8 weeks. Receives: Other: telerehabilitation with dance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 weeks
Secondary outcomes (8)
feasibility (patients opinions)
Semi structured interviews will involve gaining patients opinions on the strengths and weaknesses of the intervention
Measured: 10 weeks
feasibility (safety and usability)
The researches will follow all patients during the intervention regarding safety (i.e. falls) and usability (i.e. internet connection)
Measured: 10 weeks
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.
Measured: Change from Pre to Post treatment (10 weeks)
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)
Measured: Change from Pre to Post treatment (10 weeks)
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.
Measured: Change from Pre to Post treatment (10 weeks)
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.
Measured: Change from Pre to Post treatment (10 weeks)
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.
Measured: Change from Pre to Post treatment (10 weeks)
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.
Measured: Change from Pre to Post treatment (10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start5 Sep 2020
- Primary completion5 Oct 2020
- Study completion5 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- individuals with parkinson's disease and healthy control individuals will be assigned to the same online dance class via zoom platform.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aline de Souza Pagnussat, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04580849
- Sponsor's protocol ID
- TELEDANCE
- Status last verified
- Apr 2021
- First submitted
- 1 Oct 2020
- Last updated
- 6 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telerehabilitation Using a Dance Intervention in People With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04580849
- Acronym / sponsor ID
- TELEDANCE
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Study start
- 5 Sep 2020 (actual)
- Primary completion
- 5 Oct 2020 (actual)
- Study completion
- 5 Dec 2020 (actual)
- First posted
- 9 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to verify the feasibility of a telerehabilitation approach with dance in people with parkinson's disease.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- individuals with parkinson's disease and healthy control individuals will be assigned to the same online dance class via zoom platform.
| Arm | Type | Receives |
|---|---|---|
| telerehabilitation with dance (Parkinson's) | Experimental | Other: telerehabilitation with danceThis group will receive dance classes online during 60 minutes, twice a week for 8 weeks. |
| telerehabilitation with dance (Healthy controls) | Active comparator | Other: telerehabilitation with danceThis group will receive dance classes online during 60 minutes, twice a week for 8 weeks. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Severe visual or auditive disturbances
- Neurological disease (other than parkinson's for those included) or severe neuromuscular disorders that prejudice the proposed activities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| telerehabilitation with danceDance classes will be provided through a online platform. Each class will last 60 minutes, twice a week, during 8 weeks. | Other | telerehabilitation with dance (Healthy controls), telerehabilitation with dance (Parkinson's) |
Primary outcome
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.
8 secondary outcomes
feasibility (patients opinions)
Time frame: 10 weeks
feasibility (safety and usability)
Time frame: 10 weeks
Parkinson's Disease Questionnaire-8 (PDQ-8)
Time frame: 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)
Hospital Anxiety and Depression Scale (HADS)
Time frame: 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)
Activities-Specific Balance (ABC) Scale
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing telerehabilitation with dance in people with Parkinson Disease, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
feasibility (adherence rates) (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2021.