Trial registered on ANZCTR


Trial ID
ACTRN12609000791235
Ethics application status
Approved
Date submitted
8/09/2009
Date registered
10/09/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Training dual tasking in Parkinson's Disease
Scientific title
An investigation of single versus dual task gait training in people with Parkinson's Disease to evaluate the effects on dual tasking during gait
Secondary ID [1] 1001 0
National Health and Medical Research Council (NHMRC) project grant ID: 511170
Universal Trial Number (UTN)
Trial acronym

Health condition
Health condition(s) or problem(s) studied:
Parkinson's Disease 243690 0
Condition category
Condition code
Neurological 239959 239959 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Twelve, one-hour sessions of training walking to improve step length whilst concurrently performing added cognitive or motor tasks will be undertaken in a rehabilitation gym with a physiotherapist (three times a week for four weeks). Walking training will be one-on-one, progressed and include tasks such as walking, turning, and obstacle negotiation whilst concurrently performing added tasks such as conversation, mathematics, and route-finding. A home program of exercises and strategies will be provided.
Intervention code [1] 241235 0
Rehabilitation
Comparator / control treatment
Twelve, one-hour sessions of training walking to improve step length will be undertaken in a rehabilitation gym with a physiotherapist (three times a week for four weeks). Walking training will be one-on-one, progressed and include tasks such as walking, turning, and obstacle negotiation. A home program of exercises and strategies will be provided.
Control group
Active

Outcomes
Primary outcome [1] 240761 0
Mean step length when dual tasking over 8m
Timepoint [1] 240761 0
Baseline, Post intervention, Follow up 6 months post intervention
Secondary outcome [1] 257432 0
Spatiotemporal gait parameters (speed, cadence) over 8m under single and dual task conditions
Timepoint [1] 257432 0
Baseline, Post intervention, Follow up 6 months post intervention
Secondary outcome [2] 257433 0
Executive function using a neuropsychological test battery
Timepoint [2] 257433 0
Baseline, Post intervention, Follow up 6 months post intervention
Secondary outcome [3] 257434 0
Functional gait performance using the timed up and go test
Timepoint [3] 257434 0
Baseline, Post intervention, Follow up 6 months post intervention
Secondary outcome [4] 257435 0
Community mobility and quality of life as participation measures via questionnaires and activity monitoring
Timepoint [4] 257435 0
Baseline, Post intervention, Follow up 6 months post intervention

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
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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, visual pathology, deafness,

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
Not Applicable
Type of endpoint(s)
Efficacy

Recruitment
Anticipated date of first participant enrolment
10/09/2009
Actual date of first participant enrolment
Anticipated date last participant enrolled
Actual date last participant enrolled
Target sample size
60
Actual sample size
Recruitment status
Recruiting
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243611 0
Government body
Name [1] 243611 0
National Health and Medical Research Council
Address [1] 243611 0
National Health and Medical Research Council GPO Box 1421 Canberra ACT 2601
Country [1] 243611 0
Australia
Primary sponsor type
Individual
Name
A/Prof 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] 237060 0
None
Name [1] 237060 0
Address [1] 237060 0
Country [1] 237060 0
Other collaborator category [1] 847 0
Individual
Name [1] 847 0
Prof Meg Morris
Address [1] 847 0
School of Physiotherapy The University of Melbourne 200 Berkeley St Carlton, Vic, 3010
Country [1] 847 0
Australia
Other collaborator category [2] 848 0
Individual
Name [2] 848 0
Prof Marjorie Woollacott
Address [2] 848 0
Department of Human Physiology Institute of Neuroscience University of Oregon Eugene, OR, 97403
Country [2] 848 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243736 0
The University of Queensland Medical Research Ethics Committee
Ethics committee address [1] 243736 0
The University of Queensland St Lucia, Qld, 4072
Ethics committee country [1] 243736 0
Australia
Date submitted for ethics approval [1] 243736 0
Approval date [1] 243736 0
14/12/2007
Ethics approval number [1] 243736 0
2007001631
Ethics committee name [2] 243737 0
Princess Alexandra Hospital Medical Research Committee
Ethics committee address [2] 243737 0
Centres for Health Research Level 2, Building 35, Princess Alexandra Hospital Ipswich Rd Woolloongabba, Qld, 4102
Ethics committee country [2] 243737 0
Australia
Date submitted for ethics approval [2] 243737 0
Approval date [2] 243737 0
05/02/2009
Ethics approval number [2] 243737 0
2009/013
Ethics committee name [3] 243738 0
Uniting Care Health Human Research Ethics Committee
Ethics committee address [3] 243738 0
1st Floor Morelands House, The Wesley Hospital, 451 Coronation Drive, Auchenflower, Qld, 4066
Ethics committee country [3] 243738 0
Australia
Date submitted for ethics approval [3] 243738 0
Approval date [3] 243738 0
04/03/2009
Ethics approval number [3] 243738 0
0911

Summary
Brief summary
Difficulty performing more than one task at a time (dual tasking) is a common and disabling problem experienced by people with Parkinson disease (PD). If asked to perform another task when walking, people with PD have repeatedly shown markedly altered gait, such as taking shorter steps or walking more slowly. Currently there is uncertainty about whether clinicians should teach people with PD to avoid dual task performance or whether they should encourage them to practice dual-tasking with the hope that practice will lead to enhanced performance. This study will address this issue by comparing usual gait training to dual task gait training.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30162 0
Address 30162 0
Country 30162 0
Phone 30162 0
Fax 30162 0
Email 30162 0
Contact person for public queries
Name 13409 0
A/Prof Sandra Brauer
Address 13409 0
Division of Physiotherapy
School of Health & Rehabilitation Sciences
The University of Queensland
St Lucia, Qld, 4072
Country 13409 0
Australia
Phone 13409 0
+61 7 3365 2317
Fax 13409 0
+61 7 3365 1622
Email 13409 0
s.brauer@uq.edu.au
Contact person for scientific queries
Name 4337 0
A/Prof Sandra Brauer
Address 4337 0
Division of Physiotherapy
School of Health & Rehabilitation Sciences
The University of Queensland
St Lucia, Qld, 4072
Country 4337 0
Australia
Phone 4337 0
+61 7 3365 2317
Fax 4337 0
+61 7 3365 1622
Email 4337 0
s.brauer@uq.edu.au