Trial from ANZCTR


Trial ID ACTRN12606000344594
Trial Status: Registered
Date Submitted: 20/07/2006
Date Registered: 11/08/2006
Prospectively registered

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Public title A randomized controlled trial of strategy training compared to exercises to prevent falls and improve mobility in people with Parkinson’s Disease
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format A randomized controlled trial of strategy training compared to exercises to prevent falls and improve mobility in people with Parkinson’s Disease
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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 1315 0
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Condition category: Condition code:
Neurological Parkinson's disease
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1400 1400 0 0

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Descriptions of intervention(s) / exposure 1. Movement Strategy Training (MST): an 8-week, once-weekly 120 minute individualised program which comprises strategies to prevent falls, enhance balance and improve mobility, along with education about risk factors for falls and general education about Parkinson’s disease. Participants will also receive a once-weekly individualized and structured home program to reinforce the content of each outpatient session. The person shall also receive one home visit by an occupational therapist (OT). The OT will conduct a detailed environmental analysis using a standardized home assessment checklist and recommend home modifications to minimize falls risk.

2. Progressive Strength Training (PST): an 8-week, once-weekly 120 minute individualised program for functional strengthening of muscles such as quadriceps, hamstrings, calf, tibialis anterior, glutei, abductor and trunk muscles plus education about methods to prevent falls and general education about Parkinson’s disease. Each person shall receive a strength program that is tailored to their individual needs and reinforced by a once-weekly individualized and structured home program. An OT will perform one home visit as above except without MST.
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Intervention Code:
Prevention 1219 0
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Comparator / control treatment 3. Control group (CG): the CG will receive an 8 week, once -weekly 120 minute outpatient social activity program (games, crafts, cooking, general education about Parkinson’s) provided by an OT. Participants will also receive a once-weekly individualized and structured home program of activities. During the program, the person will receive 1 home visits by a nurse to check on general well-being, mobility or physical function.
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Control group Active
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Primary Outcome: Falls frequency: number of falls per person recorded prospectively over a 12 month period, starting from the completion of the intervention 1917 0
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Timepoint: 1917 0
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Secondary Outcome: 1. Walking speed over 10 meters 3374 0
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Timepoint: Measured at 3 and 12 months. 3374 0
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Secondary Outcome: 2. Locomotor function (using the “Timed Up & Go” test) 3375 0
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Timepoint: Measured at 3 and 12 months. 3375 0
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Secondary Outcome: 3. Activity limitation 3376 0
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Timepoint: Measured at 3 and 12 months. 3376 0
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Key inclusion criteria 1. Neurologist-confirmed diagnosis of idiopathic Parkinson's disease. 2. Cognitively intact (a Mini-Mental State Examination score of >24).
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Minimum age 18 Years
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Maximum age Not stated
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Gender Both males and females
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Healthy volunteers? No
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Key exclusion criteria 1. Other neurological disorders knwon to affect balance and gait2. Cognitive impairment (a Mini-Mental State Examination score of <24) 3. Currently taking tranquilizer medication4. Inability to walk.
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Study type Interventional
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Purpose of the study Prevention
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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) Telephone randomisation service
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Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation) Computer generated
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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
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Anticipated date of first participant enrolment 25/09/2006
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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 330
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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: Charities/Societies/Foundations 1534 0
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Name: Michael J. Fox Foundation 1534 0
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Address: 1534 0
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Country: 1534 0
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Primary Sponsor University
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Name: University of Melbourne
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Country: Australia
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Secondary Sponsor: Hospital 1348 0
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Name: Southern Health 1348 0
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Address: 1348 0
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Country: Australia 1348 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: University of Melbourne 2962 0
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Address: 2962 0
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Country: Australia 2962 0
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Approval Date: 2962 0
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HREC: 060035 2962 0
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Ethics Committee name: Southern Health -Elsternwick Private Hospital 2963 0
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Country: Australia 2963 0
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Approval Date: 2963 0
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HREC: 06046A 2963 0
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Ethics Committee name: Southern Health-Kingston Centre 2964 0
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Country: Australia 2964 0
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Approval Date: 2964 0
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Submitted Date: 2964 0
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HREC: 06046A 2964 0
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Brief summary Falls are common and disabling in people with Parkinson’s disease, affecting up to 60% of those who live at home. This clinical research trial aims to minimize the number of falls and fall-related injuries in people with Parkinson’s disease and to improve mobility and participation in life. Two physical therapy programs, known as “movement strategy training” and “strength training” will be coupled with falls education and compared with a social program plus usual care. The effects of therapy will be measured for a period of 12 months. The data analyst will be blinded to group allocation. After 12 months, quality of life is predicted to be higher in the people that receive strengthening or strategy training because falls and injuries are predicted to be less than for usual care. Quality of life in close family members is also predicted to increase, by lessening the burden of care arising from the disease. The results will provide information about which therapy programs are most effective for reducing falls and improving mobility, so that people with Parkinson’s can continue to lead safe and fulfilling lives.
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Principal Investigator
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Contact person for public queries
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Name: Professor Meg Morris
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Address: School of Physiotherapy University of Melbourne 200 Berkeley Street VIC 3010
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Country: Australia
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Tel: +61-3-8344-4171
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Fax: +61-3-8344-4188
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Email: m.morris@unimelb.edu.au
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Contact person for scientific queries
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Name: Professor Meg Morris
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Address: School of Physiotherapy University of Melbourne 200 Berkeley Street Victoria 3010
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Country: Australia
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Email: m.morris@unimelb.edu.au
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