Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001042932
Ethics application status
Approved
Date submitted
14/08/2020
Date registered
14/10/2020
Date last updated
14/10/2020
Date data sharing statement initially provided
14/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
What is the safety and feasibility of online therapeutic dancing for people with Parkinson's disease?
Scientific title
Online Dance Exercises for Parkinson’s Rehabilitation: Is it safe and feasible?
Secondary ID [1] 301903 0
Nil Known
Universal Trial Number (UTN)
U1111-1253-8251
Trial acronym
ParkinDance Online
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 318415 0
Condition category
Condition code
Neurological 316423 316423 0 0
Parkinson's disease
Physical Medicine / Rehabilitation 316986 316986 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a tele-medicine project where people with mild-Parkinson’s disease (Hoehn & Yahr stages 0-2.5) will participate in a four-week pilot of twice weekly one-hour dancing, dance steps and routines, exercises and physical activities at home, using the internet and led by a trained dance teacher. They will at first connect in real-time via a video communications platform. The Dance Instructor Manual, Video-conferencing Guide, Assessor Manual and Participant Workbook were designed specifically for this study.

Dance Instructor training & preparation: The Dance Instructors will commence weekly training with the Project Manager for 6 weeks prior to the intervention. The meetings will consist of education, planning and safety monitoring meetings with the Project Manager and provision of a Dance Instructor Manual and Video-conferencing Guide. As preparation they will each complete choreography templates and three videos each for the class phases (warm-up, active phase, cool-down). Choreography from the templates will be included in the manual. The videos will be preparation for the intervention delivery. A test-run class will be conducted with each dance instructor prior to study commencement. The templates and videos will be stored on a secure university research drive, accessed only by the Project Manager and Lead Investigator, and will not be provided to, or used by, the participants. Each participant will be assigned to one dance instructor for the four weeks. They will be participating in one-to-one “live” online classes twice per week for four consecutive weeks on days and times that are mutually agreeable. Weekly meetings will continue throughout the intervention period.

Class content: Each class will include a warm-up phase (five minutes), an active dance plus exercise phase (30 minutes incorporating rest/drink breaks) and a cool down phase (five minutes). There will be a mixture of dance genres (Tango, Irish, Tap, Salsa, Creative, Waltz and other genres at the discretion of the dance teacher) and rhythmical music types, matched and personalised to the individual preferences of participants.The classes will emphasize movement control, coordination, strength, flexibility, balance, mobility and reduction in disability. The exercise intensity will be moderate and assessed by, for example, Borg RPE or subjectively by the Instructor and the post-class response. Participants will be advised to do the classes at the mid-phase of their levodopa medication cycle where applicable. Participants receiving deep brain stimulation may not have a mid-cycle. Adherence will be measured by a session attendance checklist completed by the Dance Instructor, electronic surveys after each class and weekly documented phone calls from the project manager.

Information resources: There will be a Dance Instructor Manual as a resource for the Dance Instructors and it will contain information about Parkinson’s disease, therapeutic dancing, safety, risk management, use of digital platforms and examples of choreography.An accompanying Participant Workbook will give advice for key elements on which to focus e.g. “Focus on your feet; focus on the fast tapping of your fingers; focus on your breathing; focus on your balance and hold the chair…” as well as how to safely structure the home environment and how to check safety of furniture and equipment.There will be a participant guide to using videoconferencing. There will be an Assessor Manual for the pre- and post-intervention testing. There will be a Fidelity Checklist to evaluate that the intervention is delivered as planned.

Qualitative study: Participant experience will be explored with individual in-depth interviews via video conferencing within two weeks of the end of the intervention. There will be one interview per participant and interviews will be conducted by an experienced Qualitative researcher. The interview schedule will use prompts for participant opinions of the dance classes, what aspects were enjoyable or not enjoyable, experience of the online delivery, any environmental or safety problems and any suggestions for changes to the format or presentation. Each interview will take approximately 45 minutes and will be audio-recorded for independent verbatim transcription. Data will be thematically analysed within a phenomenological framework by two independent researchers. Consensus meetings will be used to identify the main themes. These themes will be supported by quotations from the participant data.
Intervention code [1] 318189 0
Rehabilitation
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324574 0
Gait: 6 metre walk test
Timepoint [1] 324574 0
Within one week pre-intervention and within two weeks post-intervention
Primary outcome [2] 324575 0
Balance: single limb stance test (seconds)
Timepoint [2] 324575 0
Within one week pre-intervention and within two weeks post-intervention
Primary outcome [3] 324577 0
Safety and Feasibility.
Safety will be assessed by documentation of any adverse events and actions taken; and completion of safe environment form.
Feasibility will be assessed by documentation of any protocol variations and technical issues (e.g., internet connectivity); completion of post-class participation and enjoyment surveys within intervention; and independent fidelity checks for each participant.
A composite outcome
The enjoyment survey and safe environment form used were designed specifically for this study.
Timepoint [3] 324577 0
Adverse events will be recorded at any time from enrolment until completion of the intervention after each class (weeks 1-4), Post-class participation and enjoyments within intervention completed after each class (weeks 1-4); independent fidelity checks for each participant carried out in week 2.
Secondary outcome [1] 385004 0
Motor and Non-motor experiences of daily living: The Movement Disorders Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS)

A composite outcome
Timepoint [1] 385004 0
Within one week pre-intervention and within two weeks post-intervention
Secondary outcome [2] 385005 0
Quality of Life: Parkinson’s Disease Quality of Life Questionnaire (PDQ-39)
Timepoint [2] 385005 0
Within one week pre-intervention and within two weeks post-intervention
Secondary outcome [3] 385006 0
Short Study-specific Online survey: Dance Instructor and Participant feedback
A composite secondary outcome designed for this study
Timepoint [3] 385006 0
Immediately after each class
Secondary outcome [4] 385007 0
Dance Instructor Experience: One Focus Group with the Dance Instructors
Timepoint [4] 385007 0
Within 2 weeks of completion of all interventions
Secondary outcome [5] 386837 0
Participant Experience
Timepoint [5] 386837 0
One in-depth interview per participant within 2 weeks of the completion of all intervention classes

Eligibility
Key inclusion criteria
Only people with comparatively mild symptoms of Parkinson’s disease (Hoehn & Yahr stages 0-2) who are aged 18-65 years and who can safely and independently perform exercises, physical activities and dance steps at home will be recruited. Each participant will need to have a medical practitioner complete a form to verify that they satisfy the inclusion criteria:
i. they have Parkinson’s disease (Hoehn & Yahr stages 0-2.5)
ii. are aged 18-65 years
iii. are safe to do independent exercises, physical activities and dance steps in their own home, by themselves
iv. they do not have co-morbidities or any other medical conditions that prevent safe exercise, by themselves, in their own home setting.
v. they are a willing volunteer for a home-based telemedicine research trial
vi. they have internet access and are willing to use it for the purposes of this trial
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria:
i. patients receiving Duo dopa or Apomorphine infusions
ii. cognitive impairment
iii. unable to walk independently 10 metres without aids or assistance
iv. delirium
v. dementia
vi. comorbidities preventing safe exercise such as heart or lung conditions, uncontrolled diabetes, neurological disorders or musculoskeletal conditions such as back pain, severe arthritis or cancer

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)
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Quantitative: descriptive data for all the outcome variables will be generated. Documentation of Adverse Events and adherence

Qualitative: thematic analysis of participant and dance instructor experience

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/10/2020
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 306318 0
Charities/Societies/Foundations
Name [1] 306318 0
Parkinson's Victoria
Country [1] 306318 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Plenty Road & Kingsbury Dr, Bundoora VIC 3086
Country
Australia
Secondary sponsor category [1] 306813 0
Charities/Societies/Foundations
Name [1] 306813 0
Parkinson's Victoria
Address [1] 306813 0
587 Canterbury Road Surrey Hills VIC 3127
Country [1] 306813 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306531 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 306531 0
Ethics committee country [1] 306531 0
Australia
Date submitted for ethics approval [1] 306531 0
21/05/2020
Approval date [1] 306531 0
25/05/2020
Ethics approval number [1] 306531 0
HEC18520

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104182 0
Prof Meg E. Morris
Address 104182 0
La Trobe University
Plenty Road & Kingsbury Dr, Bundoora VIC 3086
Country 104182 0
Australia
Phone 104182 0
+61 433 405 662
Fax 104182 0
Email 104182 0
[email protected]
Contact person for public queries
Name 104183 0
Emma Collin
Address 104183 0
Parkinson's Victoria
587 Canterbury Road, Surrey Hills, VIC 3127
Country 104183 0
Australia
Phone 104183 0
+61 3 8809 0400
Fax 104183 0
Email 104183 0
[email protected]
Contact person for scientific queries
Name 104184 0
Meg E. Morris
Address 104184 0
La Trobe University
Plenty Road & Kingsbury Dr, Bundoora VIC 3086
Country 104184 0
Australia
Phone 104184 0
+61 433 405 662
Fax 104184 0
Email 104184 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Researchers who provide a methodologically sound proposal
Available for what types of analyses?
meta-analysis, meta-synthesis, secondary analysis
How or where can data be obtained?
access subject to approvals by Principal Investigator ([email protected])


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseOnline Dance Therapy for People With Parkinson's Disease: Feasibility and Impact on Consumer Engagement.2021https://dx.doi.org/10.1177/15459683211046254
N.B. These documents automatically identified may not have been verified by the study sponsor.