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The Impact of Dancing in Parkinson's Disease

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Dance
Sponsored by
Centre Hospitalier Universitaire de Liege
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Site Ourthe-Amblève - CHU de LiègeRecruiting
  • CNRFRecruiting
  • CHU de Liège site Sart-TilmanRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Dance

Control

Arm Description

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.

The control group will receive its rehabilitation care.

Outcomes

Primary Outcome Measures

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.
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).

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
December 14, 2021
Last Updated
July 27, 2022
Sponsor
Centre Hospitalier Universitaire de Liege
Collaborators
Kinésiphilia
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1. Study Identification

Unique Protocol Identification Number
NCT05175365
Brief Title
The Impact of Dancing in Parkinson's Disease
Official Title
Dance in Parkinson's Disease: An Optimized and Adapted Approach to Promote the Well-being and Functional Status of Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Universitaire de Liege
Collaborators
Kinésiphilia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dance
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control group will receive its rehabilitation care.
Intervention Type
Behavioral
Intervention Name(s)
Dance
Intervention Description
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.
Primary Outcome Measure Information:
Title
Parkinson's Disease Questionnaire (PDQ-39)
Description
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.
Time Frame
16 weeks
Title
Satisfaction and well-being visual analog scale
Description
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).
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
MDS-Unified Parkinson Disease Rating Scale part III (MDSUPDRS)
Description
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.
Time Frame
16 weeks
Title
10-m walk test (10MWT)
Description
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.
Time Frame
16 weeks
Title
Time up and go
Description
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.
Time Frame
16 weeks
Title
Montreal Cognitive Assessment (MoCA)
Description
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.
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Helena Cassol, PhD
Phone
+32475474128
Ext
+32
Email
hcassol@chuliege.be
First Name & Middle Initial & Last Name or Official Title & Degree
Olivier Bouquiaux, MD
Phone
+32495501576
Ext
+32
Email
olivier.bouquiaux@chuliege.be
Facility Information:
Facility Name
Site Ourthe-Amblève - CHU de Liège
City
Esneux
State/Province
Liège
ZIP/Postal Code
4130
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helena Cassol, PhD
Phone
+32475474128
Ext
+32
Email
hcassol@chuliege.be
First Name & Middle Initial & Last Name & Degree
Olivier Bouquiaux, MD
Phone
0495501576
Ext
+32
Email
olivier.bouquiaux@chuliege.be
First Name & Middle Initial & Last Name & Degree
Olvivier Bouquiaux, MD
Facility Name
CNRF
City
Tinlot
State/Province
Liège
ZIP/Postal Code
4557
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helena Cassol, PhD
Phone
0475474128
Ext
+32
Email
hcassol@chuliege.be
First Name & Middle Initial & Last Name & Degree
Olivier Bouquiaux, MD
Phone
0495501576
Ext
+32
Email
olivier.bouquiaux@chuliege.be
First Name & Middle Initial & Last Name & Degree
Olivier Bouquiaux, MD
Facility Name
CHU de Liège site Sart-Tilman
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helena Cassol, PhD
Phone
+32475474128
Ext
+32
Email
hcassol@chuliege.be
First Name & Middle Initial & Last Name & Degree
Olivier Bouquiaux, MD
Phone
0495501576
Ext
+32
Email
olivier.bouquiaux@chuliege.be
First Name & Middle Initial & Last Name & Degree
Olivier Bouquiaux, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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The Impact of Dancing in Parkinson's Disease

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