Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000688785
Ethics application status
Approved
Date submitted
11/06/2013
Date registered
24/06/2013
Date last updated
3/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Stepping training in Parkinson’s disease: a randomised controlled trial of an interactive videogame.
Scientific title
The effects of stepping training using an interactive videogame (modified Dance Dance Revolution) on balance and gait in people with Parkinson’s disease.
Secondary ID [1] 282415 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 288997 0
Condition category
Condition code
Neurological 289343 289343 0 0
Parkinson's disease
Physical Medicine / Rehabilitation 289344 289344 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Stepping training using the modified Dance Dance Revoluation (DDR Konami) videogame 3 times a week for 3 months. Participants will perform 15 minutes of stepping practice per session and speed of stepping will be systematically increased to maintain challenge at home. Participants will receive 1 initial home visit from the physiotherapist to set up the videogame system and another home visit within a week to ensure that they are using the system safely. Participants will be provided with all equipment during the 3 month exercise period as well as a booklet containing safety precautions and instructions. Participants will be contacted by a study physiotherapist by phone once every two weeks to monitor adherence and answer any questions or concerns raised by the participant. Participants who have internet access will also be invited to participate in the online blog. If they wish to participate in the online blog, they will learn how to access, log-in and use the online blog to share their experience of using the stepping videogame with other participants. The researchers will monitor the blog daily and contribute to the blog. An additional home visit will be provided at 6 weeks to monitor progress. A final home visit will occur on completion of the 12 week program.
Intervention code [1] 287049 0
Treatment: Other
Intervention code [2] 287050 0
Rehabilitation
Comparator / control treatment
Participants will receive usual care and will be instructed to continue with their usual activities. Specifically, usual care includes any routine medical, nursing or allied health care. Usual activities included any regular physical activities undertaken by participants on entry to the study, such as regular walks or exercise sessions.
Control group
Active

Outcomes
Primary outcome [1] 289455 0
Choice stepping reaction time measured in milliseconds with and without the stroop test using a portable mat which connects with a computer and a monitor.
Timepoint [1] 289455 0
At baseline and at one week after completion of 12 weeks intervention.
Primary outcome [2] 289456 0
Functional Gait Assessment
Timepoint [2] 289456 0
At baseline and at one week after completion of 12 weeks intervention.
Secondary outcome [1] 302511 0
Peak muscle power and muscle power at low load (30% 1RM of population mean) of the hip abductor muscles, measured using Keiser pneumatic variable resistance equipment (Fresno, CA).
Timepoint [1] 302511 0
At baseline and at one week after completion of 12 weeks intervention.
Secondary outcome [2] 302513 0
Timed Up and Go test performed with and without a concurrent cognitive dual-task.
Timepoint [2] 302513 0
At baseline and at one week after completion of 12 weeks.
Secondary outcome [3] 302514 0
Trail making tests A and B.
Timepoint [3] 302514 0
At baseline and at one week after completion of 12 weeks intervention.
Secondary outcome [4] 302515 0
Montreal Cognitive Assessment.
Timepoint [4] 302515 0
At baseline and at one week after completion of 12 weeks intervention.
Secondary outcome [5] 302516 0
Hand reaction time test.
Timepoint [5] 302516 0
At baseline and at one week after completion of 12 weeks intervention.
Secondary outcome [6] 302517 0
Obstacle avoidance test.
Timepoint [6] 302517 0
At baseline and at one week after completion of 12 weeks intervention.
Secondary outcome [7] 302518 0
Fear of falling using the Falls Efficacy Scale International.
Timepoint [7] 302518 0
At baseline and at one week after completion of 12 weeks intervention.
Secondary outcome [8] 302519 0
Freezing of gait using the New Freezing of Gait Questionnaire.
Timepoint [8] 302519 0
At baseline and at one week after completion of 12 weeks intervention.
Secondary outcome [9] 302520 0
Global perceived effect of the participant’s perception of the effect of the intervention, using a standard 10 point scale.
Timepoint [9] 302520 0
At one week after completion of 12 weeks intervention.
Secondary outcome [10] 302521 0
Performance and adherence measures recorded by the videogame system.
Timepoint [10] 302521 0
Over 12 weeks of intervention.
Secondary outcome [11] 302522 0
Number of falls, recorded using monthly falls diaries.
Timepoint [11] 302522 0
Over 6 months after randomisation .

Eligibility
Key inclusion criteria
Diagnosis of idiopathic Parkinson’s disease
Stable PD medications for at least 2 weeks
Able to walk for 30m independently without a walking aid
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Mini-Mental State Examination Score less than 24/30
Any unstable cardiovascular, orthopaedic or neurological conditions that would interfere with the safety of assessment and/or interpretation of results

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)
Randomisation will be performed off-site by an investigator not involved in participant recruitment using block randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer will be used to generate the randomisation schedule
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Between group comparisons of final test performance for the continuously-scored outcome measures will be made using General Linear Models (ANCOVA) controlled for pre-test performance. An intention-to-treat approach will be used. Calculations of statistical power based on scores from our previous work in people with PD suggest 60 participants (30 per group) will be sufficient to detect a 20% between-group difference in choice stepping reaction time (assuming a control group mean is equal to 36 seconds and SD is equal to 10) with 80% power at the 5% alpha level, a correlation between pre- and post measures of 0.8 and 15% dropouts. An estimate of the effect on falls will also be calculated, to inform sample size calculations for any future trial to determine the effect on the intervention on fall rates.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2013
Actual
10/07/2013
Date of last participant enrolment
Anticipated
Actual
2/09/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 287185 0
University
Name [1] 287185 0
The University of Sydney
Country [1] 287185 0
Australia
Funding source category [2] 287186 0
Charities/Societies/Foundations
Name [2] 287186 0
Parkinson's NSW
Country [2] 287186 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
PO Box 170, Lidcombe NSW 1825
Country
Australia
Secondary sponsor category [1] 285949 0
None
Name [1] 285949 0
Address [1] 285949 0
Country [1] 285949 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289182 0
Research Integrity Human Research Ethics Committee
Ethics committee address [1] 289182 0
Research Integrity
Research Portfolio
Level 6, Jane Foss Russell Building
The University of Sydney, NSW 2006
Ethics committee country [1] 289182 0
Australia
Date submitted for ethics approval [1] 289182 0
25/02/2013
Approval date [1] 289182 0
01/05/2013
Ethics approval number [1] 289182 0
2013/207

Summary
Brief summary
Reduced balance and gait are debilitating impairments associated with PD. A home-based interactive stepping videogame has been shown to be an enjoyable and effective form of training in the general older population. The aim of this randomised controlled trial is to determine if a home-based, interactive, stepping videogame for people with PD is effective in improving balance and gait. Secondary aims are to determine the effect on muscle power, mobility, fear of falling and freezing of gait, and to provide data that will establish an effect size for fall rates to inform the design of future trials. The use of the online blog to enhance participation and engagement in the training, as well as gauge acceptability of the interactive stepping videogame program, will also be evaluated. Since poor balance is a major risk factor for falls in people with PD, the development of effective, sustainable and engaging exercise programs to improve balance is an urgent research priority.
Trial website
Trial related presentations / publications
Presented at Australian and New Zealand Falls Prevention Conference 2014 (17/11/2014)
Title - Slow step movement time is associated with past falls in Parkinson's disease.
Public notes

Contacts
Principal investigator
Name 39642 0
A/Prof Colleen Canning
Address 39642 0
Physiotherapy, Faculty of Health Sciences
The University of Sydney
PO Box 170
Lidcombe NSW 1825
Country 39642 0
Australia
Phone 39642 0
+61 2 9351 9263
Fax 39642 0
+61 2 9351 9278
Email 39642 0
[email protected]
Contact person for public queries
Name 39643 0
Dr Jooeun Song
Address 39643 0
Physiotherapy, Faculty of Health Sciences
The University of Sydney
PO Box 170
Lidcombe NSW 1825
Country 39643 0
Australia
Phone 39643 0
+61 2 9351 9436
Fax 39643 0
+61 2 9351 9278
Email 39643 0
[email protected]
Contact person for scientific queries
Name 39644 0
A/Prof Colleen Canning
Address 39644 0
Physiotherapy, Faculty of Health Sciences
The University of Sydney
PO Box 170
Lidcombe NSW 1825
Country 39644 0
Australia
Phone 39644 0
+61 2 9351 9263
Fax 39644 0
+61 2 9351 9278
Email 39644 0
[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
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseExecutive functioning, muscle power and reactive balance are major contributors to gait adaptability in people with Parkinson's disease.2019https://dx.doi.org/10.3389/fnagi.2019.00154
N.B. These documents automatically identified may not have been verified by the study sponsor.