Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000344594
Ethics application status
Approved
Date submitted
20/07/2006
Date registered
11/08/2006
Date last updated
16/06/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomized controlled trial of strategy training compared to exercises to prevent falls and improve mobility in people with Parkinson’s Disease
Scientific title
A randomized controlled trial of strategy training compared to exercises to prevent falls and improve mobility in people with Parkinson’s Disease
Secondary ID [1] 289477 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 1315 0
Condition category
Condition code
Neurological 1400 1400 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description 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.
Intervention code [1] 1219 0
Prevention
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.
Control group
Active

Outcomes
Primary outcome [1] 1917 0
Falls frequency: number of falls per person recorded prospectively over a 12 month period, starting from the completion of the intervention
Timepoint [1] 1917 0
12 months post last intervention session
Secondary outcome [1] 3374 0
1. Walking speed over 10 meters
Timepoint [1] 3374 0
Measured at 3 and 12 months.
Secondary outcome [2] 3375 0
2. Locomotor function (using the “Timed Up & Go” test)
Timepoint [2] 3375 0
Measured at 3 and 12 months.
Secondary outcome [3] 3376 0
3. Activity limitation
Timepoint [3] 3376 0
Measured at 3 and 12 months.

Eligibility
Key inclusion criteria
1. Neurologist-confirmed diagnosis of idiopathic Parkinson's disease. 2. Cognitively intact (a Mini-Mental State Examination score of >24).
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Telephone randomisation service
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/09/2006
Actual
1/11/2006
Date of last participant enrolment
Anticipated
Actual
1/09/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
330
Accrual to date
Final
240
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 1534 0
Charities/Societies/Foundations
Name [1] 1534 0
Michael J. Fox Foundation
Country [1] 1534 0
United States of America
Primary sponsor type
University
Name
University of Melbourne
Address
Department of Physiotherapy, The University of Melbourne, Carlton Vic 3010
Country
Australia
Secondary sponsor category [1] 1348 0
Hospital
Name [1] 1348 0
Southern Health
Address [1] 1348 0
Monash Health, Kingston Centre, 400 Warrigal Road, Cheltenham, Vic 3192
Country [1] 1348 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2962 0
University of Melbourne
Ethics committee address [1] 2962 0
Ethics committee country [1] 2962 0
Australia
Date submitted for ethics approval [1] 2962 0
Approval date [1] 2962 0
25/07/2008
Ethics approval number [1] 2962 0
060035
Ethics committee name [2] 2963 0
Southern Health -Elsternwick Private Hospital
Ethics committee address [2] 2963 0
Ethics committee country [2] 2963 0
Australia
Date submitted for ethics approval [2] 2963 0
Approval date [2] 2963 0
Ethics approval number [2] 2963 0
06046A
Ethics committee name [3] 2964 0
Southern Health-Kingston Centre
Ethics committee address [3] 2964 0
Ethics committee country [3] 2964 0
Australia
Date submitted for ethics approval [3] 2964 0
Approval date [3] 2964 0
03/07/2006
Ethics approval number [3] 2964 0
06046A

Summary
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.
Trial website
Trial related presentations / publications
Morris, M.E., et al., A Randomized Controlled Trial to Reduce Falls in People With Parkinson’s Disease. Neurorehabilitation and Neural Repair, 2015: p. 1545968314565511
Public notes

Contacts
Principal investigator
Name 36235 0
Prof Prof Meg Morris
Address 36235 0
Head School Allied Health, College Science, Health & Engineering, La Trobe University, Vic. 3086 Australia
Country 36235 0
Australia
Phone 36235 0
+61 433 405 662
Fax 36235 0
Email 36235 0
m.morris@latrobe.edu.au
Contact person for public queries
Name 10408 0
Prof Professor Meg Morris
Address 10408 0
Head School Allied Health, College Science, Health & Engineering, La Trobe University, Vic. 3086 Australia
Country 10408 0
Australia
Phone 10408 0
+61 433 405 662
Fax 10408 0
nil
Email 10408 0
m.morris@latrobe.edu.au
Contact person for scientific queries
Name 1336 0
Prof Professor Meg Morris
Address 1336 0
Head School Allied Health, College Science, Health & Engineering, La Trobe University, Vic. 3086 Australia
Country 1336 0
Australia
Phone 1336 0
+61 433 405 662
Fax 1336 0
nil
Email 1336 0
m.morris@unimelb.edu.au

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
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4211Study results articleYes Morris, ME, et al. 2015a, ‘A randomized controlled... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA Randomized Controlled Trial to Reduce Falls in People with Parkinson's Disease.2015https://dx.doi.org/10.1177/1545968314565511
EmbaseFalls and mobility in Parkinson's disease: Protocol for a randomised controlled clinical trial.2011https://dx.doi.org/10.1186/1471-2377-11-93
N.B. These documents automatically identified may not have been verified by the study sponsor.