Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001834246
Ethics application status
Approved
Date submitted
6/11/2018
Date registered
12/11/2018
Date last updated
12/11/2018
Date data sharing statement initially provided
12/11/2018
Date results information initially provided
12/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of dance for Parkinson’s on gait, cognitive function and dual tasking in Parkinson’s disease
Scientific title
Effects of dance for Parkinson’s on gait, cognitive function and dual tasking in Parkinson’s disease
Secondary ID [1] 296534 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 310313 0
Condition category
Condition code
Neurological 309049 309049 0 0
Parkinson's disease
Physical Medicine / Rehabilitation 309064 309064 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The main intervention for this study is the dance classes based on the internationally recognised DfPD® programme, which was developed by the Brooklyn Parkinson Group and Mark Morris Dance Group in New York. The programme is specially designed for people with Parkinson’s disease (PD). The classes are taught by six DfPD® trained instructors who are routinely conducting the dance for PD classes at Queensland Ballet. The class is a one hour class once a week and runs for a period of three months. The classes involve seated dancing, standing dancing and progressive standing dancing (i.e. moving across the floor). The class consists a 30-minute seated warm-up, followed by 15 minutes each of standing dance then progressive standing dance. The seated dance techniques include gentle upper body movement, slow feet warm-up, different improvisational dances and dance patterns which involved articulation of the spine and head, and facial expressions. Standing dance contains repeated stretching of the leg and pointing the foot (‘‘tendu,’’ a basic ballet step) and bending the knees with feet in various positions (plie´).The progressive standing dance consists of a mixture of choreographed sequences, improvisation, theatrical interpretation, and group dancing. These dance classes include aspects of ballet, modern dance, choreographic repertory, jazz, tap, Irish dancing, and salsa. The music used in the classes ranges from classical to modern.
The adherence for the dance classes is monitored using the attendance checklists.
The study has a quasi-experimental design. Allocation to the dance group or the control group was based on the availability of the participant. Therefore the random allocation was not achieved.
Intervention code [1] 312841 0
Rehabilitation
Comparator / control treatment
The study has a quasi-experimental parallel group pre-test post-test design with a Dance Group and a Control Group. Dance group undergoes a one-hour dance class twice a week for three months while the control group is treated as usual. The control group consists individuals who are clinically diagnosed as idiopathic PD, who are not involved in any dance-related intervention and who have not danced for the past six months and are following their normal medication and exercise routine during the intervention period.
Control group
Active

Outcomes
Primary outcome [1] 308009 0
Gait velocity
Vicon 3D motion analysis system
Timepoint [1] 308009 0
One week before the intervention commencement (pre) and one week after the intervention completion (post)
Primary outcome [2] 308010 0
Cognition - Executive function
National Institutes of Health Tool Box
Trail Making Test
Timepoint [2] 308010 0
One week before the intervention commencement (pre) and one week after the intervention completion (post)
Primary outcome [3] 308011 0
Gait velocity during dual task
Vicon 3D motion analysis system
Timepoint [3] 308011 0
One week before the intervention commencement (pre) and one week after the intervention completion (post)
Secondary outcome [1] 353644 0
cadence
Vicon 3D motion analysis system
Timepoint [1] 353644 0
One week before the intervention commencement (pre) and one week after the intervention completion (post)
Secondary outcome [2] 353645 0
language
National Institutes of Health Tool Box
Timepoint [2] 353645 0
One week before the intervention commencement (pre) and one week after the intervention completion (post)
Secondary outcome [3] 353646 0
Functional mobility
Timed Up and Go test, Berge Balance Scale, and Mini-BESTest
Timepoint [3] 353646 0
One week before the intervention commencement (pre) and one week after the intervention completion (post)
Secondary outcome [4] 353647 0
Fine manual dexterity
Perdue Peg Board
Timepoint [4] 353647 0
One week before the intervention commencement (pre) and one week after the intervention completion (post)
Secondary outcome [5] 353648 0
Quality of life
Parkinson’s disease Questionnaire - 39
Timepoint [5] 353648 0
One week before the intervention commencement (pre) and one week after the intervention completion (post)
Secondary outcome [6] 353649 0
Caregiver burden
Caregiver burden scale
Timepoint [6] 353649 0
One week before the intervention commencement (pre) and one week after the intervention completion (post)
Secondary outcome [7] 353650 0
Level of activity
ActivPAL activity monitors
Timepoint [7] 353650 0
One week before the intervention commencement (pre) and one week after the intervention completion (post)
Secondary outcome [8] 353651 0
Psychological symptoms (anxiety and depression)
Hospital Anxiety and Depression Scale
Timepoint [8] 353651 0
One week before the intervention commencement (pre) and one week after the intervention completion (post)
Secondary outcome [9] 353652 0
Disease severity
Movement Disorder’s society – Unified Parkinson’s disease Rating Scale
Timepoint [9] 353652 0
One week before the intervention commencement (pre) and one week after the intervention completion (post)
Secondary outcome [10] 353818 0
step length
Vicon 3D motion analysis system
Timepoint [10] 353818 0
One week before the intervention commencement (pre) and one week after the intervention completion (post)Vicon 3D motion analysis system
Secondary outcome [11] 353819 0
stride length
Vicon 3D motion analysis system
Timepoint [11] 353819 0
One week before the intervention commencement (pre) and one week after the intervention completion (post)
Secondary outcome [12] 353820 0
Cognition -episodic memory
National Institutes of Health Tool Box
Timepoint [12] 353820 0
One week before the intervention commencement (pre) and one week after the intervention completion (post)
Secondary outcome [13] 353821 0
Cognition -working memory
National Institutes of Health Tool Box
Timepoint [13] 353821 0
One week before the intervention commencement (pre) and one week after the intervention completion (post)
Secondary outcome [14] 353822 0
Cognition -processing speed
National Institutes of Health Tool Box
Timepoint [14] 353822 0
One week before the intervention commencement (pre) and one week after the intervention completion (post)

Eligibility
Key inclusion criteria
1) clinically diagnosed as having idiopathic PD, using the diagnostic criteria for clinically defined "definite PD" based on published standards, 2) aged between 40-85 years; 3) in mild to moderate stage of PD (I-III on Hoehn and Yahr scale), 4) with no dementia (Addenbrooke’s scale greater than or equal to 82), 5) with no clinically significant co-morbidities: medical, neurological (other than PD), musculoskeletal, cardiovascular or respiratory abnormalities, and 6) able to walk independently for at least 3 m without an assistive device
Minimum age
40 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
To avoid possible carry-over effects, participants who were engaged in any dance or dance related programmes during the past six months were excluded. In addition, those with Addenbrooke’s scale less than 82, and those with confounding medical, neurologic, musculoskeletal, cardiovascular or respiratory abnormalities were excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Chi-square test will be applied to compare the categorical variables and the independent sample t-test was used for continuous variables. General Linear Model (GLM) will be applied for the pre-post change scores. A linear mixed model (LMM) will be used to compare the repeated measures.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
3/07/2017
Date of last participant enrolment
Anticipated
Actual
17/08/2017
Date of last data collection
Anticipated
Actual
31/05/2018
Sample size
Target
32
Accrual to date
Final
33
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 301114 0
University
Name [1] 301114 0
Queensland University of Technology
Country [1] 301114 0
Australia
Funding source category [2] 301115 0
Government body
Name [2] 301115 0
University Grants Commision, Sri Lanka
Country [2] 301115 0
Sri Lanka
Primary sponsor type
University
Name
Queensland University of Technology
Address
Queensland University of Technology, Brisbane, Australia
Desk no. 630-07
Q Block - IHBI, 60 Musk Avenue, Kelvin Grove QLD 4059
Country
Australia
Secondary sponsor category [1] 300731 0
None
Name [1] 300731 0
Address [1] 300731 0
Country [1] 300731 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301865 0
University Human Research Ethics Committee (UHREC) at QUT
Ethics committee address [1] 301865 0
University Human Research Ethics Committee (UHREC)
Queensland University of Technology
2 George St
Brisbane, QLD 4000
Ethics committee country [1] 301865 0
Australia
Date submitted for ethics approval [1] 301865 0
Approval date [1] 301865 0
13/02/2017
Ethics approval number [1] 301865 0
1700000005

Summary
Brief summary
Individuals with Parkinson disease (PD) often demonstrate postural instability, gait difficulties, and reduced functional mobility that can lead to decreased quality of life. While there is accumulating evidence supporting dance as an effective management option in alleviating the symptoms of PD, there is a limited number of studies that have objectively assessed the effects of dance, particularly related to the Dance for Parkinson’s Disease® (DfPD®) programme. Therefore this study aimed to explore the impact of dance classes based on the DfPD® model, on gait during normal walking and dual-tasking, cognition, functional mobility, fine manual dexterity, anxiety, depression, quality of life and caregiver burden in people with Parkinson’s disease (PD). We hypothesised that improvements in the above outcomes would be noted in the dance group while no improvements would be noted in the untreated control group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88366 0
Ms Nadeesha Kalyani Hewa Haputhanthirige
Address 88366 0
Queensland University of Technology, Brisbane, Australia
Desk no. 630-07
Q Block - IHBI, 60 Musk Avenue, Kelvin Grove QLD 4059
Country 88366 0
Australia
Phone 88366 0
+61 450076061
Fax 88366 0
Email 88366 0
[email protected]
Contact person for public queries
Name 88367 0
Ms Nadeesha Kalyani Hewa Haputhanthirige
Address 88367 0
Queensland University of Technology, Brisbane, Australia
Desk no. 630-07
Q Block - IHBI, 60 Musk Avenue, Kelvin Grove QLD 4059
Country 88367 0
Australia
Phone 88367 0
+61 450076061
Fax 88367 0
Email 88367 0
[email protected]
Contact person for scientific queries
Name 88368 0
Ms Nadeesha Kalyani Hewa Haputhanthirige
Address 88368 0
Queensland University of Technology, Brisbane, Australia
Desk no. 630-07
Q Block - IHBI, 60 Musk Avenue, Kelvin Grove QLD 4059
Country 88368 0
Australia
Phone 88368 0
+61 450076061
Fax 88368 0
Email 88368 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffects of dance on gait and dual-task gait in Parkinson's disease.2023https://dx.doi.org/10.1371/journal.pone.0280635
N.B. These documents automatically identified may not have been verified by the study sponsor.