ANZCTR - Registration

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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]

nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Parkinson's disease

Condition category

Condition code

Neurological

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]

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]

Falls frequency: number of falls per person recorded prospectively over a 12 month period, starting from the completion of the intervention

Timepoint [1]

12 months post last intervention session

Secondary outcome [1]

1. Walking speed over 10 meters

Timepoint [1]

Measured at 3 and 12 months.

Secondary outcome [2]

2. Locomotor function (using the “Timed Up & Go” test)

Timepoint [2]

Measured at 3 and 12 months.

Secondary outcome [3]

3. Activity limitation

Timepoint [3]

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?

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]

Charities/Societies/Foundations

Name [1]

Michael J. Fox Foundation

Address [1]

The Michael J. Fox Foundation for Parkinson's Research, New York, New York, USA.

Country [1]

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]

Hospital

Name [1]

Southern Health

Address [1]

Monash Health, Kingston Centre, 400 Warrigal Road, Cheltenham, Vic 3192

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Melbourne

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

25/07/2008

Ethics approval number [1]

060035

Ethics committee name [2]

Southern Health -Elsternwick Private Hospital

Ethics committee address [2]

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

Ethics approval number [2]

06046A

Ethics committee name [3]

Southern Health-Kingston Centre

Ethics committee address [3]

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

Approval date [3]

03/07/2006

Ethics approval number [3]

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

Prof Prof Meg Morris

Address

Head School Allied Health, College Science, Health & Engineering, La Trobe University, Vic. 3086 Australia

Country

Australia

Phone

+61 433 405 662

Fax

[email protected]

Contact person for public queries

Name

Professor Meg Morris

Address

Head School Allied Health, College Science, Health & Engineering, La Trobe University, Vic. 3086 Australia

Country

Australia

Phone

+61 433 405 662

Fax

nil

[email protected]

Contact person for scientific queries

Name

Professor Meg Morris

Address

Head School Allied Health, College Science, Health & Engineering, La Trobe University, Vic. 3086 Australia

Country

Australia

Phone

+61 433 405 662

Fax

nil

[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

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		Morris, ME, et al. 2015a, ‘A randomized controlled... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Falls and mobility in Parkinson's disease: Protocol for a randomised controlled clinical trial.	2011	https://dx.doi.org/10.1186/1471-2377-11-93
Embase	A Randomized Controlled Trial to Reduce Falls in People with Parkinson's Disease.	2015	https://dx.doi.org/10.1177/1545968314565511

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically