Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001016820
Ethics application status
Approved
Date submitted
19/09/2012
Date registered
20/09/2012
Date last updated
20/09/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Safety, feasibility and efficacy of a dance intervention for people with Parkinson's disease: a pilot study
Scientific title
A randomised controlled trial of the safety and efficacy of a dance intervention compared to usual care on gait in people with Parkinson's disease
Secondary ID [1] 281264 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic Parkinson's disease 287467 0
Condition category
Condition code
Neurological 287799 287799 0 0
Parkinson's disease
Physical Medicine / Rehabilitation 287806 287806 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will complete 1 hour weekly dance classes for 8 weeks, led by a professional dance instructor under guidance of experienced physiotherapists. Participants will also be asked to adhere to a 1 hour weekly home-based mental rehearsal program
Intervention code [1] 285737 0
Rehabilitation
Comparator / control treatment
Usual care control group. Particpants in this group will be able to continue with usual physiotherapy or exercise routines throughout the study
Control group
Active

Outcomes
Primary outcome [1] 288018 0
Feasibility assessed by adherence, safety, attrition and participant acceptibility. Safety will be assessed by monitoring and reporting any adverse events that occur during the 8 dance classes. Participant acceptibility information will be collected and assessed during an open focus group for the dance participants after the 8 weeks of dancing.
Timepoint [1] 288018 0
Adherence, safety and attrition will be monitored and assessed for the 8 week interevention period. Participant acceptibility will be assessed at 8 weeks.
Primary outcome [2] 288019 0
Gait speed measured by 6-meter walk test
Timepoint [2] 288019 0
at baseline and at 8 week and 3 month follow-up assessments
Secondary outcome [1] 299290 0
Functional mobility measured by the Timed-up and Go
Timepoint [1] 299290 0
at baseline and at 8 week and 3 month follow-up assessments
Secondary outcome [2] 299291 0
Balance measured by the Mini BESTest
Timepoint [2] 299291 0
at baseline and at 8 week and 3 month follow-up assessments
Secondary outcome [3] 299292 0
Self efficacy measured by the Ambulatory self-confidence questionnaire and the Activities-specific balance confidence scale
Timepoint [3] 299292 0
at baseline and at 8 week and 3 month follow-up assessments
Secondary outcome [4] 299293 0
Quality of life measured by the PDQ-39
Timepoint [4] 299293 0
at baseline and at 8 week and 3 month follow-up assessments

Eligibility
Key inclusion criteria
1. Diagnosed with idiopathic Parkinson's disease by a Neurologist
2. Living in the community/at home
3. Aged under 75 years of age
4. Between Hoehn and Yahr stage 1-3
5. Be medically safe to participate in an active exercise program, as assessed by the patients Neurologist, GP or other medical practitioner
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Unable to communicate in English
2. Have dementia, score less than 24 on the Mini Mental State Examination (MMSE) or are unable to provide informed consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A blinded independent person will assign participants with sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An independent person will randomly allocate participants using a computer generated number sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/10/2012
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)

Funding & Sponsors
Funding source category [1] 286034 0
University
Name [1] 286034 0
La Trobe University
Country [1] 286034 0
Australia
Primary sponsor type
Individual
Name
Prof Meg Morris
Address
Faculty of Health Sciences
La Trobe University
Bundoora, VIC 3086
Country
Australia
Secondary sponsor category [1] 284846 0
Individual
Name [1] 284846 0
Dr Jenny McGinley
Address [1] 284846 0
The University of Melbourne
200 Berkeley Street
Carlton, VIC 3010
Country [1] 284846 0
Australia
Other collaborator category [1] 277080 0
Individual
Name [1] 277080 0
Rebecca Twyerould
Address [1] 277080 0
The University of Melbourne
200 Berkeley Street
Carlton, VIC 3010
Country [1] 277080 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288082 0
Behavioral and Social Sciences Human Ethics sub-committee
Ethics committee address [1] 288082 0
Human Research Ethics
Level 5, Alan Gilbert Building,
161 Barry St
Carlton, VIC 3053
Ethics committee country [1] 288082 0
Australia
Date submitted for ethics approval [1] 288082 0
Approval date [1] 288082 0
19/09/2012
Ethics approval number [1] 288082 0
1237989

Summary
Brief summary
The aim of this pilot study is to explore the feasibility and efficacy of a rehabilitative dance intervention designed to reduce disability and to improve quality of life in a small sample of adults with Parkinson’s disease.
Twenty adults with PD will be recruited and randomly allocated to either a usual care group or an 8-week dance intervention. Gait, balance and quality of life will be measured in all participants at baseline, 8 weeks and 3 months. Additionally, the intervention will be assessed for feasibility in terms of adherence, attrition safety and participant acceptability. The results of this study are designed to inform and verify the methodology for a larger subsequent RCT and to determine the feasibility of dancing for a small group of people with PD
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34738 0
Address 34738 0
Country 34738 0
Phone 34738 0
Fax 34738 0
Email 34738 0
Contact person for public queries
Name 17985 0
Prof Meg Morris
Address 17985 0
Faculty of Health Sciences La Trobe University
Bundoora, VIC 3086
Country 17985 0
Australia
Phone 17985 0
+61 3 9479 6080
Fax 17985 0
Email 17985 0
[email protected]
Contact person for scientific queries
Name 8913 0
Prof Meg Morris
Address 8913 0
Faculty of Health Sciences La Trobe University
Bundoora, VIC 3086
Country 8913 0
Australia
Phone 8913 0
+61 3 9479 6080
Fax 8913 0
Email 8913 0
[email protected]

No information has been provided regarding IPD availability


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
No additional documents have been identified.