Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05175365
Other study ID # 2021-313
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT05415774 - Combined Deep Brain Stimulation in Parkinson's Disease N/A
Recruiting NCT04691661 - Safety, Tolerability, Pharmacokinetics and Efficacy Study of Radotinib in Parkinson's Disease Phase 2
Active, not recruiting NCT05754086 - A Multidimensional Study on Articulation Deficits in Parkinsons Disease
Completed NCT04045925 - Feasibility Study of the Taïso Practice in Parkinson's Disease N/A
Recruiting NCT04194762 - PARK-FIT. Treadmill vs Cycling in Parkinson´s Disease. Definition of the Most Effective Model in Gait Reeducation N/A
Completed NCT02705755 - TD-9855 Phase 2 in Neurogenic Orthostatic Hypotension (nOH) Phase 2
Terminated NCT03052712 - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies N/A
Recruiting NCT05830253 - Free-living Monitoring of Parkinson's Disease Using Smart Objects
Recruiting NCT03272230 - Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based System N/A
Recruiting NCT06139965 - Validity and Reliability of the Turkish Version of the Comprehensive Coordination Scale in Parkinson's Patients
Completed NCT04580849 - Telerehabilitation Using a Dance Intervention in People With Parkinson's Disease N/A
Completed NCT04477161 - Effect of Ketone Esters in Parkinson's Disease N/A
Completed NCT03980418 - Evaluation of a Semiconductor Camera for the DaTSCAN™ Exam N/A
Completed NCT04942392 - Digital Dance for People With Parkinson's Disease During the COVID-19 Pandemic N/A
Terminated NCT03446833 - LFP Beta aDBS Feasibility Study N/A
Completed NCT03497884 - Individualized Precise Localization of rTMS on Primary Motor Area N/A
Completed NCT05538455 - Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases N/A
Recruiting NCT04997642 - Parkinson's Disease and Movement Disorders Clinical Database
Completed NCT04117737 - A Pilot Study of Virtual Reality and Antigravity Treadmill for Gait Improvement in Parkinson N/A
Recruiting NCT03618901 - Rock Steady Boxing vs. Sensory Attention Focused Exercise N/A