NCT04580849

Brief Summary

The aim of this study is to verify the feasibility of a telerehabilitation approach with dance in people with parkinson's disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Sep 2020

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

Study Start

First participant enrolled

September 5, 2020

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

October 1, 2020

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 9, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2020

Completed
Last Updated

April 6, 2021

Status Verified

April 1, 2021

Enrollment Period

1 month

First QC Date

October 1, 2020

Last Update Submit

April 5, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    10 weeks

Secondary Outcomes (8)

  • feasibility (patients opinions)

    10 weeks

  • feasibility (safety and usability)

    10 weeks

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

    Change from Pre to Post treatment (10 weeks)

  • 36-Item Short Form Survey (SF-36)

    Change from Pre to Post treatment (10 weeks)

  • Hospital Anxiety and Depression Scale (HADS)

    Change from Pre to Post treatment (10 weeks)

  • +3 more secondary outcomes

Study Arms (2)

telerehabilitation with dance (Parkinson's)

EXPERIMENTAL

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

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.

Other: telerehabilitation with dance

Interventions

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

telerehabilitation with dance (Healthy controls)telerehabilitation with dance (Parkinson's)

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Severe visual or auditive disturbances
  • Neurological disease (other than parkinson's for those included) or severe neuromuscular disorders that prejudice the proposed activities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal de Ciências da Saúde de Porto Alegre

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

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesTelemedicineDelivery of Health CarePatient Care ManagementHealth Services Administration

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: individuals with parkinson's disease and healthy control individuals will be assigned to the same online dance class via zoom platform.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 1, 2020

First Posted

October 9, 2020

Study Start

September 5, 2020

Primary Completion

October 5, 2020

Study Completion

December 5, 2020

Last Updated

April 6, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations