Online Dance Versus Therapeutic Exercise for Parkinson Disease.

Study Overview
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Brief Summary
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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

Official Title
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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.

Conditions
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Parkinson Disease

Intervention / Treatment
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* Other: Dance & Music (Online)
* Other: Multimodal Therapeutic Exercise & Music (Online)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial with two groups
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group Dance & Music (Online)<br>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)<br>* 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<br>|
| Active Comparator: Group Multimodal Therapeutic Exercise & Music (Online)<br>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)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson Disease, Dance, Physiotherapy, Telehealth, Telerehabilitation