Trial from ANZCTR


Trial ID ACTRN12609000791235
Trial Status: Registered
Date Submitted: 8/09/2009
Date Registered: 10/09/2009
Prospectively registered

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Public title Training dual tasking in Parkinson's Disease
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format An investigation of single versus dual task gait training in people with Parkinson's Disease to evaluate the effects on dual tasking during gait
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Secondary ID [1] 1001 0
National Health and Medical Research Council (NHMRC) project grant ID: 511170
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UTN
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Trial acronym
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Health condition(s) or problem(s) studied:
Parkinson's Disease 243690 0
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Condition category: Condition code:
Neurological Parkinson's disease
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239959 239959 0 0

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Descriptions 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.
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Intervention Code:
Rehabilitation 241235 0
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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.
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Control group Active
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Primary Outcome: Mean step length when dual tasking over 8m 240761 0
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Timepoint: Baseline, Post intervention, Follow up 6 months post intervention 240761 0
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Secondary Outcome: Spatiotemporal gait parameters (speed, cadence) over 8m under single and dual task conditions 257432 0
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Timepoint: Baseline, Post intervention, Follow up 6 months post intervention 257432 0
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Secondary Outcome: Executive function using a neuropsychological test battery 257433 0
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Timepoint: Baseline, Post intervention, Follow up 6 months post intervention 257433 0
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Secondary Outcome: Functional gait performance using the timed up and go test 257434 0
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Timepoint: Baseline, Post intervention, Follow up 6 months post intervention 257434 0
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Secondary Outcome: Community mobility and quality of life as participation measures via questionnaires and activity monitoring 257435 0
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Timepoint: Baseline, Post intervention, Follow up 6 months post intervention 257435 0
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Key inclusion criteria Diagnosed with ideopathic Parkinson's Disease, be medically stable, score >23 on the Mini Mental Status Examination, demonstrate gait hypokinesia
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Minimum age 18 Years
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Maximum age No limit
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Gender Both males and females
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Healthy volunteers? No
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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,
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Study type Interventional
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Purpose of the study Treatment
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Allocation to intervention Randomised controlled trial
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Describe the 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.
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Describe the 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 .
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Masking / blinding Blinded (masking used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Parallel
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Other design features
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Type of endpoint(s) Efficacy
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Statistical Methods/Analysis
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Phase Not Applicable
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Anticipated date of first participant enrolment 10/09/2009
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled
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Target sample size 60
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Recruitment status Recruiting
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Recruitment in Australia

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Recruitment outside Australia

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Funding Source: Government body 243611 0
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Name: National Health and Medical Research Council 243611 0
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Address: National Health and Medical Research Council GPO Box 1421 Canberra ACT 2601 243611 0
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Country: Australia 243611 0
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Primary Sponsor Individual
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Name: A/Prof Sandra Brauer
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Address: Division of Physiotherapy School of Health & Rehabilitation Sciences The University of Queensland St Lucia, Qld, 4072
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Country: Australia
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Secondary Sponsor: None 237060 0
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Address: 237060 0
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Other Collaborator: Individual 847 0
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Name: Prof Meg Morris 847 0
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Address: School of Physiotherapy The University of Melbourne 200 Berkeley St Carlton, Vic, 3010 847 0
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Country: Australia 847 0
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Other Collaborator: Individual 848 0
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Name: Prof Marjorie Woollacott 848 0
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Address: Department of Human Physiology Institute of Neuroscience University of Oregon Eugene, OR, 97403 848 0
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Country: United States of America 848 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: The University of Queensland Medical Research Ethics Committee 243736 0
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Address: The University of Queensland St Lucia, Qld, 4072 243736 0
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Country: Australia 243736 0
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Approval Date: 14/12/2007 243736 0
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Submitted Date: 243736 0
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HREC: 2007001631 243736 0
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Ethics Committee name: Princess Alexandra Hospital Medical Research Committee 243737 0
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Address: Centres for Health Research Level 2, Building 35, Princess Alexandra Hospital Ipswich Rd Woolloongabba, Qld, 4102 243737 0
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Country: Australia 243737 0
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Approval Date: 05/02/2009 243737 0
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Submitted Date: 243737 0
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HREC: 2009/013 243737 0
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Ethics Committee name: Uniting Care Health Human Research Ethics Committee 243738 0
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Address: 1st Floor Morelands House, The Wesley Hospital, 451 Coronation Drive, Auchenflower, Qld, 4066 243738 0
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Country: Australia 243738 0
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Approval Date: 04/03/2009 243738 0
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Submitted Date: 243738 0
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HREC: 0911 243738 0
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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.
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Trial website
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Principal Investigator
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Contact person for public queries
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Name: A/Prof Sandra Brauer
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Address: Division of Physiotherapy School of Health & Rehabilitation Sciences The University of Queensland St Lucia, Qld, 4072
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Country: Australia
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Tel: +61 7 3365 2317
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Fax: +61 7 3365 1622
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Email: s.brauer@uq.edu.au
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Contact person for scientific queries
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Name: A/Prof Sandra Brauer
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Address: Division of Physiotherapy School of Health & Rehabilitation Sciences The University of Queensland St Lucia, Qld, 4072
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Country: Australia
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Contact person responsible for updating information
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Name: A/Prof Sandra Brauer
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Address: Division of Physiotherapy School of Health & Rehabilitation Sciences The University of Queensland St Lucia, Qld, 4072
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Country: Australia
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Tel: +61 7 3365 2317
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