Telerehabilitation Using a Dance Intervention in People With Parkinson's Disease

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

telerehabilitation with dance

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Universidade Federal de Ciências da Saúde de Porto Alegre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

telerehabilitation with dance (Parkinson's)

telerehabilitation with dance (Healthy controls)

Arm Description

This group will receive dance classes online during 60 minutes, twice a week for 8 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

feasibility (patients opinions)

Semi structured interviews will involve gaining patients opinions on the strengths and weaknesses of the intervention

feasibility (safety and usability)

The researches will follow all patients during the intervention regarding safety (i.e. falls) and usability (i.e. internet connection)

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.

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)

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.

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.

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.

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.

Full Information

NCT ID

NCT04580849

First Posted

October 1, 2020

Last Updated

April 5, 2021

Sponsor

Federal University of Health Science of Porto Alegre

1. Study Identification

Unique Protocol Identification Number

NCT04580849

Brief Title

Telerehabilitation Using a Dance Intervention in People With Parkinson's Disease

Official Title

Telerehabilitation Using a Dance Intervention in People With Parkinson's Disease

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

September 5, 2020 (Actual)

Primary Completion Date

October 5, 2020 (Actual)

Study Completion Date

December 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Federal University of Health Science of Porto Alegre

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Allocation

Non-Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

telerehabilitation with dance (Parkinson's)

Arm Type

Experimental

Arm Description

This group will receive dance classes online during 60 minutes, twice a week for 8 weeks.

Arm Title

telerehabilitation with dance (Healthy controls)

Arm Type

Active Comparator

Arm Description

This group will receive dance classes online during 60 minutes, twice a week for 8 weeks.

Intervention Type

Other

Intervention Name(s)

telerehabilitation with dance

Intervention Description

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

Primary Outcome Measure Information:

Title

feasibility (adherence rates)

Description

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.

Time Frame

10 weeks

Secondary Outcome Measure Information:

Title

feasibility (patients opinions)

Description

Semi structured interviews will involve gaining patients opinions on the strengths and weaknesses of the intervention

Time Frame

10 weeks

Title

feasibility (safety and usability)

Description

The researches will follow all patients during the intervention regarding safety (i.e. falls) and usability (i.e. internet connection)

Time Frame

10 weeks

Title

Parkinson's Disease Questionnaire-8 (PDQ-8)

Description

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.

Time Frame