The Impact of Dancing in Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Dance in Parkinson's Disease: An Optimized and Adapted Approach to Promote the Well-being and Functional Status of Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05175365
• Other study ID #: 2021-313
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: January 2025

Study information

• Verified date: July 2022
• Source: Centre Hospitalier Universitaire de Liege
• Contact: Helena Cassol, PhD
• Phone: +32475474128
• Email: hcassol[@]chuliege.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This clinical study intends to confirm the results of previous studies showing the positive effect of dance on patients with Parkinson's disease on both mental and physical health via a randomized controlled trial. Patients will be randomized into the intervention group (dance courses in addition to standard care) or in the control group (standard care).

Description:

This is a clinical study on the benefits of dance in Parkinson's disease. In recent years, dance has become an interesting strategy to promote motor and non-motor functions in Parkinson's disease. More than a rehabilitation strategy, dance appears to be an optimal approach to promote functional outcomes as it combines physical, rhythmic, cognitive, emotional and social elements that could have a positive impact on multiple impairments in Parkinson's disease. The investigators believe that the notion of pleasure is crucial for rehabilitation, especially in people suffering from depression, and that it is often not taken into account in conventional rehabilitation strategies.

The goal of the present study is to confirm these preliminary results. This clinical study will run over two years, from January 2022 to January 2024, but an experimental session will last 4 months. The aim of this protocol is to better characterize the impact of dance on well-being, disease progression and possible neuronal reorganization in patients with Parkinson's disease. A better quality of life, a higher level of satisfaction and an improvement in functional status are expected in the experimental group.

During this study, three examinations will be carried out over 4 months. One at the start of the study, one at mid-term (after 8 weeks) and one at the end of the study. These evaluations will take place at the place of the dance lessons for the experimental group and within the university hospital for the control group.

Assessment will be done through different scales and questionnaires to assess well-being, satisfaction, feelings of happiness, functional status, cognitive functions and the correlation between functional and cognitive progress and neuronal activity.

This study is a "controlled and randomized" study that is to say that in a random manner, half of the participants will participate in weekly dance sessions lasting 60 minutes in addition to their conventional physiotherapy sessions while the control group will only receive conventional physiotherapy sessions during the first 4 months but will still benefit from dance sessions after the 4 months of evaluation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: January 2025
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient with Parkinson's disease

• Hoehn & Yahr Stadium <3

• Signature of the written consent form

Exclusion Criteria:

• No cardiac or respiratory or neurological or rheumatological disease incompatible with the practice of a physical activity

• Has not had any surgery interfering with motor function in the past 6 months

• Has no cognitive impairment - MoCA <26

• Does not present hearing problems that do not all

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Behavioral:
• Dance
Each session consists of a 60-minute dance class taught by a professional dancer. Dance classes begin with a seated warm-up with various coordination, rhythm, range of motion, memorization and coordination exercises. The level of difficulty of the exercises increases as the sessions progress. Balance is also an important part of training as well as the feeling of being part of a group, of interacting with each other. The hour ends with stretching in a sitting position.

Locations

Country	Name	City	State
Belgium	Site Ourthe-Amblève - CHU de Liège	Esneux	Liège
Belgium	CHU de Liège site Sart-Tilman	Liège
Belgium	CNRF	Tinlot	Liège

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Liege	Kinésiphilia

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parkinson's Disease Questionnaire (PDQ-39)	This questionnaire assesses how often people affected by Parkinson's experience difficulties across 8 dimensions of daily living including relationships, social situations and communication. It also assesses the impact of Parkinson's on specific dimensions of functioning and well-being. Each dimension total score ranges from 0 (never have difficulty) to 100 (always have difficulty). Lower scores reflect better quality of life.	16 weeks
Primary	Satisfaction and well-being visual analog scale	Patients will have to rate their feeling of satisfaction and well-being on a scale ranging from 0 (worst/lowest state of satisfaction and happiness) to 100 (highest state of satisfaction and happiness).	16 weeks
Secondary	MDS-Unified Parkinson Disease Rating Scale part III (MDSUPDRS)	The Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is a comprehensive 50 question assessment of both motor and non-motor symptoms associated with Parkinson's. The investigators will administer part III only (motor examination). Higher scores reflect greater difficulties.	16 weeks
Secondary	10-m walk test (10MWT)	This test is used and recommended as a measure of gait speed in Parkinson's disease (PD). It measures the speed in seconds of spontaneous and fastest rate walking.	16 weeks
Secondary	Time up and go	At the signal from the assessor ("Go ahead"), the person should stand up and walk away.; a comfortable and safe speed up to a line drawn on the floor (3 m further), turn, then come back and sit down. A first attempt should be made to familiarize the person with the test. The test therefore comprises an exercise and subsequently an "official" test. Results: the investigator starts the timing at "Go ahead" and stops it when the person has returned to a seated position.; The time of the course (in seconds) is retained as the final score. The test will be judged positive (mobility disorders, risk of falling) if the score exceeds 12 to 14 seconds.	16 weeks
Secondary	Montreal Cognitive Assessment (MoCA)	This scale includes 30 items assessing multiple cognitive domains: short-term memory (5 points); visuospatial abilities via clock drawing (3 points) and a cube copy task (1 point); executive functioning via an adaptation of Trail Making Test part B (1 point), phonemic fluency (1 point) and verbal abstraction (2 points); attention, concentration and working memory via target detection (1 point), serial subtraction (3 points), digits forward (1 point) and digits backward (1 point); language via confrontation naming with low-familiarity animals (3 points) and repetition of complex sentences (2 points); and orientation to time and place (6 points). Items are summed to create a score and the clinical cut-off score is equal to 26.	16 weeks