Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000238673
Ethics application status
Approved
Date submitted
26/08/2005
Date registered
29/08/2005
Date last updated
28/11/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Training dual task performance in parkinson's disease
Scientific title
The effects of dual task training on gait in Parkinson's disease: Part A: Training prioritisation of tasks
Secondary ID [1] 126 0
Parkinson's disease
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 324 0
Condition category
Condition code
Neurological 370 370 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group prioritises attention on gait
Intervention code [1] 270 0
Rehabilitation
Comparator / control treatment
The control group prioritises attention on a secondary cognitive task
Control group
Active

Outcomes
Primary outcome [1] 431 0
Gait speed
Timepoint [1] 431 0
Secondary outcome [1] 941 0
Stride length
Timepoint [1] 941 0
Secondary outcome [2] 942 0
Cadence
Timepoint [2] 942 0
Secondary outcome [3] 943 0
ADl
Timepoint [3] 943 0
Secondary outcome [4] 944 0
QOL
Timepoint [4] 944 0

Eligibility
Key inclusion criteria
Idiopathic Parkinson's
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Other neurological, musculoskeltal or cardiopulmonary conditions.

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)
Sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
SPSS software will be used to generate the random allocation sequence and stratification will be used for the restriction method.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
N/A
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 429 0
University
Name [1] 429 0
University
Country [1] 429 0
Primary sponsor type
Individual
Name
Professor Meg Morris, University of Melbourne School of physiotherapy
Address
Country
Australia
Secondary sponsor category [1] 347 0
Hospital
Name [1] 347 0
Hospital
Address [1] 347 0
Country [1] 347 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The response to two different gait training protocols will be compared
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35117 0
Address 35117 0
Country 35117 0
Phone 35117 0
Fax 35117 0
Email 35117 0
Contact person for public queries
Name 9459 0
Professor Meg Morris
Address 9459 0
Kingston Centre
Warrigal Rd
Cheltenham VIC 3192
Country 9459 0
Australia
Phone 9459 0
+61 3 92651202
Fax 9459 0
+61 3 92651577
Email 9459 0
[email protected]
Contact person for scientific queries
Name 387 0
Professor Meg Morris
Address 387 0
Kingston Centre
Warrigal Rd
Cheltenham VIC 3192
Country 387 0
Australia
Phone 387 0
+61 3 92651202
Fax 387 0
+61 3 92651577
Email 387 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
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Documents added automatically
No additional documents have been identified.