Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000230358
Ethics application status
Approved
Date submitted
10/03/2008
Date registered
5/05/2008
Date last updated
8/09/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Training how to dual task when walking in Parkinson's Disease
Scientific title
An investigation of variable-priority training versus fixed-priority training in people with Parkinson's Disease to evaluate the effects on dual tasking during gait
Secondary ID [1] 529 0
NHMRC project grant ID: 511170
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's Disease 2920 0
Condition category
Condition code
Neurological 3053 3053 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One twenty-minute session of training walking to improve step length whilst concurrently performing cognitive tasks will be undertaken. Subjects will be asked to walk 25m repeatedly whilst concurrently performing cognitive tasks such as counting or word generation. Subjects undergoing variable-priority training will be instructed to vary the degree of attention paid to step length and the cognitive tasks, between trials.
Intervention code [1] 2648 0
Rehabilitation
Comparator / control treatment
One twenty-minute session of training walking to improve step length whilst concurrently performing cognitive tasks will be undertaken. Subjects will be asked to walk 25m repeatedly whilst concurrently performing cognitive tasks such as counting or word generation. Subjects undergoing fixed-priority training will be instructed to always attend equally to step length and the cognitive tasks in all trials.
Control group
Active

Outcomes
Primary outcome [1] 3936 0
Mean step length when dual tasking over 8m
Timepoint [1] 3936 0
Immediately following the 20 minute training session
Primary outcome [2] 3937 0
Mean gait speed when dual tasking over 8m
Timepoint [2] 3937 0
Immediately following the 20 minute training session
Secondary outcome [1] 6617 0
Cadence when dual tasking over 8m
Timepoint [1] 6617 0
Immediately following the 20 minute training session
Secondary outcome [2] 6618 0
Step variability when dual tasking over 8m
Timepoint [2] 6618 0
Immediately following the 20 minute training session
Secondary outcome [3] 6619 0
Correct response rate of the concurrent cognitive task
Timepoint [3] 6619 0
Immediately following the 20 minute training session

Eligibility
Key inclusion criteria
Diagnosed with ideopathic Parkinson's Disease, be medically stable, score >23 on the Mini Mental Status Examination, demonstrate gait hypokinesia
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
visual pathology, deafness, neurological conditions other than Parkinson's Disease, or musculoskeletal or cardiopulmonary conditions that affect the ability to safely walk repeatedly, dyskinesias that interfere with daily functioning,

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)
Off-site concealed randomisation will be prepared by a researcher using a computer generated random number sequence. Consecutively numbered, randomly ordered opaque envelopes containing group allocation will be opened consecutively by the therapist implementing the two types of intervention. The person recruiting thus will not know to which group the subject will be allocated.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated random number will be used to generate the sequence .
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/05/2008
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)
Recruitment postcode(s) [1] 599 0
4000

Funding & Sponsors
Funding source category [1] 3170 0
Government body
Name [1] 3170 0
National Health and Medical Research Council
Country [1] 3170 0
Australia
Primary sponsor type
Individual
Name
Dr Sandra Brauer
Address
Division of Physiotherapy
School of Health & Rehabilitation Sciences
The University of Queensland
St Lucia, Qld, 4072
Country
Australia
Secondary sponsor category [1] 2842 0
None
Name [1] 2842 0
Address [1] 2842 0
Country [1] 2842 0
Other collaborator category [1] 229 0
Individual
Name [1] 229 0
Prof Meg Morris
Address [1] 229 0
School of Physiotherapy
The University of Melbourne
200 Berkeley St Carlton, Vic, 3010
Country [1] 229 0
Australia
Other collaborator category [2] 230 0
Individual
Name [2] 230 0
Prof Marjorie Woollacott
Address [2] 230 0
Department of Human Physiology
Institute of Neuroscience
University of Oregon
Eugene, OR, 97403
Country [2] 230 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5150 0
The University of Queensland Medical Research Ethics Committee
Ethics committee address [1] 5150 0
Ethics committee country [1] 5150 0
Australia
Date submitted for ethics approval [1] 5150 0
Approval date [1] 5150 0
14/12/2007
Ethics approval number [1] 5150 0
2007001631
Ethics committee name [2] 5376 0
Princess Alexandra Hospital Medical Research Committee
Ethics committee address [2] 5376 0
Ethics committee country [2] 5376 0
Australia
Date submitted for ethics approval [2] 5376 0
Approval date [2] 5376 0
03/04/2008
Ethics approval number [2] 5376 0
2008/047

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

Contacts
Principal investigator
Name 28431 0
Address 28431 0
Country 28431 0
Phone 28431 0
Fax 28431 0
Email 28431 0
Contact person for public queries
Name 11588 0
Dr Sandra Brauer
Address 11588 0
Division of Physiotherapy
School of Health & Rehabilitation Sciences
The University of Queensland
St Lucia, Qld, 4072
Country 11588 0
Australia
Phone 11588 0
07 3365 2317
Fax 11588 0
07 3365 1622
Email 11588 0
[email protected]
Contact person for scientific queries
Name 2516 0
Dr Sandra Brauer
Address 2516 0
Division of Physiotherapy
School of Health & Rehabilitation Sciences
The University of Queensland
St Lucia, Qld, 4072
Country 2516 0
Australia
Phone 2516 0
07 3365 2317
Fax 2516 0
07 3365 1622
Email 2516 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.