The Impact of Dancing in Parkinson's Disease

July 27, 2022 updated by: Helena Cassol, Centre Hospitalier Universitaire de Liege

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Liège, Belgium, 4000
        • Recruiting
        • CHU de Liège site Sart-Tilman
        • Contact:
        • Contact:
        • Principal Investigator:
          • Olivier Bouquiaux, MD
    • Liège
      • Esneux, Liège, Belgium, 4130
        • Recruiting
        • Site Ourthe-Amblève - CHU de Liège
        • Contact:
        • Contact:
        • Principal Investigator:
          • Olvivier Bouquiaux, MD
      • Tinlot, Liège, Belgium, 4557
        • Recruiting
        • CNRF
        • Contact:
        • Principal Investigator:
          • Olivier Bouquiaux, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Dance
Patients allocated to this group will attend dance classes for patients with Parkinson's disease given once a week over a 4-month period for a total of 16 dance sessions.
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.
NO_INTERVENTION: Control
The control group will receive its rehabilitation care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parkinson's Disease Questionnaire (PDQ-39)
Time Frame: 16 weeks
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
Satisfaction and well-being visual analog scale
Time Frame: 16 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
MDS-Unified Parkinson Disease Rating Scale part III (MDSUPDRS)
Time Frame: 16 weeks
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
10-m walk test (10MWT)
Time Frame: 16 weeks
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
Time up and go
Time Frame: 16 weeks

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
Montreal Cognitive Assessment (MoCA)
Time Frame: 16 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2022

Primary Completion (ANTICIPATED)

January 1, 2024

Study Completion (ANTICIPATED)

January 1, 2025

Study Registration Dates

First Submitted

December 14, 2021

First Submitted That Met QC Criteria

December 14, 2021

First Posted (ACTUAL)

January 3, 2022

Study Record Updates

Last Update Posted (ACTUAL)

July 29, 2022

Last Update Submitted That Met QC Criteria

July 27, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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