Back to resultsOnline Dance Versus Therapeutic Exercise for Parkinson Disease.
Primary Purpose
Parkinson Disease
Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Dance & Music (Online)
Multimodal Therapeutic Exercise & Music (Online)
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson Disease, Dance, Physiotherapy, Telehealth, Telerehabilitation
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of idiopathic PD according to the clinical criteria of the London Brain Bank Criteria (2006); Age between 40-90 years; A minimum score of 18 in the Montreal Cognitive Assessment; Drug therapy/exercise stable for at least four weeks before the study starts; Agreement to participate in the study according to the Informed Consent Form. Exclusion Criteria: Auditory and/or visual disturbances that compromise understanding simple commands; Access to the internet and a device to access online classes; A house member and/or caregiver at home for supervision during the entire experiment, including evaluations and interventions. For patients scoring less than 2.5 points on the modified Hoehn and Yahr Scale (indicating mild disease impairment, independence in daily living activities, and no risk of falls), the requirement for household member supervision may be waived.
Sites / Locations
- AlineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group Dance & Music (Online)
Group Multimodal Therapeutic Exercise & Music (Online)
Arm Description
Social Telerehabilitation with Dance & Music (Online): The dance intervention will be instructed by a physiotherapist and dance professional, who will follow a structure based on the materials of the Dance for Parkinson's (USA) ® method
Social Telerehabilitation with Multimodal Therapeutic Exercise & Music (Online): The intervention with multimodal therapeutic exercise will be instructed by a physiotherapist, who will follow a structure based on a previous study and Physical Therapy Guidelines for People with PD
Outcomes
Primary Outcome Measures
Assessment of Quality of life
Quality of life measured by Parkinson's Disease Questionnaire (PDQ-39). Scores range from 0-100 (100 = maximum level of problems).
Assessment of Well-being
Well-being measured by the scale Positive and Negative Affect Scale (PANAS). scores range from 10 - 50, a higher score indicates more of a positive affect.
Secondary Outcome Measures
Assessment of Motor symptoms severity
Motor symptoms severity measured by the scale Unified Parkinson's disease rating scale, motor subscale (UPDRS III). Part III: Motor examination: 18 items. Score range: 0-132, 32 and below is mild, 59 and above is severe.
Assessment of Functional lower extremity strength
Functional lower extremity strength measured by the Five times sit to stand test (FTSTS). The time to complete the test is measured, where lower time to perform sit to stand represents better functional lower extremity strength
Assessment of Symptoms of Anxiety
Symptoms of Anxiety measured by the Parkinson Anxiety Scale (PAS). Scores range from 0-48 (48= maximum level of problems).
Assessment of Attention and Memory Recognition
Executive function by means attention and memory recognition measureb by Online Attention Test (OAT) and Recognition Memory Test (RMT).
Feasibility (self-perceptions)
Self-perceptions (feasibility) of technology usability, socialization and benefits of interventions based on a structured interview.
Full Information
NCT ID
NCT05910216
First Posted
May 25, 2023
Last Updated
October 9, 2023
Sponsor
Federal University of Health Science of Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT05910216
Brief Title
Online Dance Versus Therapeutic Exercise for Parkinson Disease.
Official Title
Online Dance Versus Online Therapeutic Exercise on Quality of Life - A Protocol for a Randomized Controlled Trial Investigating Social Telerehabilitation Efficacy in Parkinson's Disease.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 16, 2023 (Anticipated)
Primary Completion Date
January 16, 2024 (Anticipated)
Study Completion Date
February 16, 2024 (Anticipated)
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a randomized clinical trial in an online format, which will only include people with PD randomly divided into two groups:
Group 1 - Social Telerehabilitation with Dance and Music Group 2 - Social Telerehabilitation with Multimodal Therapeutic Exercise and Music
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson Disease, Dance, Physiotherapy, Telehealth, Telerehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial with two groups
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group Dance & Music (Online)
Arm Type
Experimental
Arm Description
Social Telerehabilitation with Dance & Music (Online): The dance intervention will be instructed by a physiotherapist and dance professional, who will follow a structure based on the materials of the Dance for Parkinson's (USA) ® method
Arm Title
Group Multimodal Therapeutic Exercise & Music (Online)
Arm Type
Active Comparator
Arm Description
Social Telerehabilitation with Multimodal Therapeutic Exercise & Music (Online): The intervention with multimodal therapeutic exercise will be instructed by a physiotherapist, who will follow a structure based on a previous study and Physical Therapy Guidelines for People with PD
Intervention Type
Other
Intervention Name(s)
Dance & Music (Online)
Intervention Description
This is a social telerehabilitation with dance and music. It will include artistic form, imageries using scenic arts, imageries using aspects of theater and storytelling, movement improvisation, choreography and sequence of movements, complex dance movements, fluidity of movement or connection between one movement and another, rhythmicity and/or movement built with music. It will include instructions for motor learning, music, and socialization
Intervention Type
Other
Intervention Name(s)
Multimodal Therapeutic Exercise & Music (Online)
Intervention Description
This is a social telerehabilitation with multimodal therapeutic Exercise and Music. It is restricted to the execution of movements within series and standardized and fixed repetitions, with a background music. It will not include dance. It will include instructions for motor learning, music, and socialization.
Primary Outcome Measure Information:
Title
Assessment of Quality of life
Description
Quality of life measured by Parkinson's Disease Questionnaire (PDQ-39). Scores range from 0-100 (100 = maximum level of problems).
Time Frame
Change from Pre to Post treatment (12 weeks) and FOLLOW-UP (after 4 weeks of study ending)
Title
Assessment of Well-being
Description
Well-being measured by the scale Positive and Negative Affect Scale (PANAS). scores range from 10 - 50, a higher score indicates more of a positive affect.
Time Frame
Change from Pre to Post treatment (12 weeks) and FOLLOW-UP (after 4 weeks of study ending)
Secondary Outcome Measure Information:
Title
Assessment of Motor symptoms severity
Description
Motor symptoms severity measured by the scale Unified Parkinson's disease rating scale, motor subscale (UPDRS III). Part III: Motor examination: 18 items. Score range: 0-132, 32 and below is mild, 59 and above is severe.
Time Frame
Change from Pre to Post treatment (12 weeks) and FOLLOW-UP (after 4 weeks of study ending)
Title
Assessment of Functional lower extremity strength
Description
Functional lower extremity strength measured by the Five times sit to stand test (FTSTS). The time to complete the test is measured, where lower time to perform sit to stand represents better functional lower extremity strength
Time Frame
Change from Pre to Post treatment (12 weeks)
Title
Assessment of Symptoms of Anxiety
Description
Symptoms of Anxiety measured by the Parkinson Anxiety Scale (PAS). Scores range from 0-48 (48= maximum level of problems).
Time Frame
Change from Pre to Post treatment (12 weeks)
Title
Assessment of Attention and Memory Recognition
Description
Executive function by means attention and memory recognition measureb by Online Attention Test (OAT) and Recognition Memory Test (RMT).
Time Frame
Change from Pre to Post treatment (12 weeks)
Title
Feasibility (self-perceptions)
Description
Self-perceptions (feasibility) of technology usability, socialization and benefits of interventions based on a structured interview.
Time Frame
Change from Pre to Post treatment (12 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of idiopathic PD according to the clinical criteria of the London Brain Bank Criteria (2006);
Age between 40-90 years;
A minimum score of 18 in the Montreal Cognitive Assessment;
Drug therapy/exercise stable for at least four weeks before the study starts;
Agreement to participate in the study according to the Informed Consent Form.
Exclusion Criteria:
Auditory and/or visual disturbances that compromise understanding simple commands;
Access to the internet and a device to access online classes;
A house member and/or caregiver at home for supervision during the entire experiment, including evaluations and interventions. For patients scoring less than 2.5 points on the modified Hoehn and Yahr Scale (indicating mild disease impairment, independence in daily living activities, and no risk of falls), the requirement for household member supervision may be waived.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aline Pagnussat, PhD
Phone
+555133038833
Email
alinespagnussat@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Aline Pagnussat
Phone
+555133038833
Email
alinespagnussat@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aline Pagnussat, PhD
Organizational Affiliation
Federal University of Health Science of Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aline
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90050-170
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aline Pagnussat
Phone
+555133038700
Email
alinespagnussat@gmail.com
First Name & Middle Initial & Last Name & Degree
Camila Pinto, PhD
First Name & Middle Initial & Last Name & Degree
Rafaela Simon Myra, MsC
First Name & Middle Initial & Last Name & Degree
Aline Hass, Professor, PhD
First Name & Middle Initial & Last Name & Degree
Francisca Pereira, PT
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Online Dance Versus Therapeutic Exercise for Parkinson Disease.
We'll reach out to this number within 24 hrs