Online Dance Versus Therapeutic Exercise for Parkinson Disease.

Parkinson Disease Clinical Trial

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.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05910216
• Other study ID #: ONLINEREHABPD
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 16, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: April 2024
• Source: Federal University of Health Science of Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: June 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• Dance & Music (Online)
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
• Multimodal Therapeutic Exercise & Music (Online)
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.

Locations

Country	Name	City	State
Brazil	Aline	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	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).	Change from Pre to Post treatment (12 weeks) and FOLLOW-UP (after 4 weeks of study ending)
Primary	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.	Change from Pre to Post treatment (12 weeks) and FOLLOW-UP (after 4 weeks of study ending)
Secondary	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.	Change from Pre to Post treatment (12 weeks) and FOLLOW-UP (after 4 weeks of study ending)
Secondary	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	Change from Pre to Post treatment (12 weeks)
Secondary	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).	Change from Pre to Post treatment (12 weeks)
Secondary	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).	Change from Pre to Post treatment (12 weeks)
Secondary	Feasibility (self-perceptions)	Self-perceptions (feasibility) of technology usability, socialization and benefits of interventions based on a structured interview.	Change from Pre to Post treatment (12 weeks)