NCT05910216

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for not_applicable parkinson-disease

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

October 16, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

December 3, 2025

Status Verified

April 1, 2024

Enrollment Period

8 months

First QC Date

May 25, 2023

Last Update Submit

November 25, 2025

Conditions

Keywords

Parkinson DiseaseDancePhysiotherapyTelehealthTelerehabilitation

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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 Outcomes (5)

  • Assessment of Motor symptoms severity

    Change from Pre to Post treatment (12 weeks) and FOLLOW-UP (after 4 weeks of study ending)

  • Assessment of Functional lower extremity strength

    Change from Pre to Post treatment (12 weeks)

  • Assessment of Symptoms of Anxiety

    Change from Pre to Post treatment (12 weeks)

  • Assessment of Attention and Memory Recognition

    Change from Pre to Post treatment (12 weeks)

  • Feasibility (self-perceptions)

    Change from Pre to Post treatment (12 weeks)

Study Arms (2)

Group Dance & Music (Online)

EXPERIMENTAL

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

Other: Dance & Music (Online)

Group Multimodal Therapeutic Exercise & Music (Online)

ACTIVE COMPARATOR

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

Other: Multimodal Therapeutic Exercise & Music (Online)

Interventions

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

Group Dance & 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.

Group Multimodal Therapeutic Exercise & Music (Online)

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aline

Porto Alegre, Rio Grande do Sul, 90050-170, Brazil

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Aline Pagnussat, PhD

    Federal University of Health Science of Porto Alegre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial with two groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 25, 2023

First Posted

June 18, 2023

Study Start

October 16, 2023

Primary Completion

May 30, 2024

Study Completion

June 30, 2024

Last Updated

December 3, 2025

Record last verified: 2024-04

Locations