Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001042538
Ethics application status
Approved
Date submitted
22/09/2015
Date registered
7/10/2015
Date last updated
24/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Transfer effects of step training on stepping performance in untrained directions among older adults
Scientific title
Investigating the effects of step training on stepping performance in untrained directions in older people
Secondary ID [1] 287264 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stepping performance 295814 0
Condition category
Condition code
Physical Medicine / Rehabilitation 296075 296075 0 0
Other physical medicine / rehabilitation
Injuries and Accidents 296614 296614 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A training session (15 minutes) will be undertaken in the laboratory at Neuroscience Research Australia (NeuRA).
Participants will be assigned to one of three groups; forward step training (Arm 1), forward plus lateral step training (Arm 2), or no training group (Arm 3). Participants in the arms 1 and 2 will be asked to undertake step training while standing and taking quick and appropriate steps on the mat. A Step Training System (modified version of "Dance Dance Revolution (DDR)") was used to train stepping performance in forward direction only (Arm 1) or both forward and lateral directions (Arm 2). Individual training sessions will be conducted by a trained researcher who will monitor compliance to the training throughout the 15 minute session.
Intervention code [1] 292504 0
Treatment: Other
Intervention code [2] 292960 0
Prevention
Comparator / control treatment
Rest period of 15 minutes
Control group
Active

Outcomes
Primary outcome [1] 295753 0
Choice stepping reaction time (decision/movement time) in diagonal direction

Note: The foot lift off and landing times were recorded by the exergame software and stepping mat. The decision and movement times will be calculated as times from stimulus to foot lift off and foot lift off to landing onto a stepping point (diagonal direction), respectively.
Timepoint [1] 295753 0
after 15min of step training (intervention group) or rest (control group)
Primary outcome [2] 295831 0
Stepping distance in diagonal direction

Note: Trajectories of toe markers from the original standing position to a stepping target (diagonal direction) will be recorded using the Vicon Bonita System.
Timepoint [2] 295831 0
after 15 min of step training (intervention group) or rest (control group)
Secondary outcome [1] 316609 0
Stepping accuracy in diagonal direction

Note: As stepping accuracy, deviation of toe markers from the center of stepping targets (diagonal direction) will be recorded and calculated using the Vicon Bonita System and Matlab.
Timepoint [1] 316609 0
after 15 min of step training (intervention group) or rest (control group)
Secondary outcome [2] 317597 0
Stepping precision in diagonal direction

Note: The stepping precision will be quantified by the calculation of error circles, based on the average relative distance between landing points on each stepping target using the Vicon Bonita System and Matlab.
Timepoint [2] 317597 0
after 15 min of step training (intervention group) or rest (control group)
Secondary outcome [3] 317598 0
Stepping reaction time (decision/movement time) in lateral direction

Note: The foot lift off and landing times were recorded by the exergame software and stepping mat. The decision and movement times will be calculated as times from stimulus to foot lift off and foot lift off to landing onto a stepping point (lateral direction), respectively.
Timepoint [3] 317598 0
after 15 min of step training (intervention group) or rest (control group)
Secondary outcome [4] 317605 0
Stepping distance in lateral direction

Note: Trajectories of toe markers from the original standing position to a stepping target (lateral direction) will be recorded using the Vicon Bonita System.
Timepoint [4] 317605 0
after 15 min of step training (intervention group) or rest (control group)
Secondary outcome [5] 317606 0
Stepping accuracy in lateral direction

Note: As stepping accuracy, deviation of toe markers from the center of stepping targets (lateral direction) will be recorded and calculated using the Vicon Bonita System and Matlab.
Timepoint [5] 317606 0
after 15 min of step training (intervention group) or rest (control group)
Secondary outcome [6] 317607 0
Stepping precision in lateral direction

Note: The stepping precision will be quantified by the calculation of error circles, based on the average relative distance between landing points on each stepping target (lateral direction) using the Vicon Bonita System and Matlab.
Timepoint [6] 317607 0
after 15 min of step training (intervention group) or rest (control group)

Eligibility
Key inclusion criteria
1) Do not have acute or chronic disorders that affect either their stepping or their cognitive performance
2) Able to understand and perform step training and assessments
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
unable to stand unassisted, have a significant visual, cognitive or neurological impairment (including Dementia, Alzheimer’s, Parkinson’s Disease or Multiple Sclerosis) and insufficient English language skills to understand the assessment procedure

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomised into one of three groups: 1) forward step training; 2) lateral plus forward step trainining; 3) no training control group.
The group allocation for each participant will be concealed by a research assistant and the information will be sent to an assessor/instructor by email.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a random number created with Excel 2010.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Two-way repeated measures ANOVA will be applied to examine the potential interaction of time (pre/post) and group (forward step training/lateral plus forward step training/control) for the primary and secondary outcome measures. Post hoc analysis will be conducted with Bonferroni adjustment.

A total of 42 was estimated as required sample size to detect significant interaction of time and group based on our pilot data (effect size = 0.3, a = 0.0166 (0.05/3), power = 0.8, number of groups = 3, number of measurements = 2, correlation among repeated measures = 0.5, nonsphericity correction = 1). Based on this calculation, we will recruit 45 participants.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/03/2015
Actual
20/03/2015
Date of last participant enrolment
Anticipated
30/11/2015
Actual
16/11/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
54
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 291824 0
Government body
Name [1] 291824 0
Japan Society for the Promotion of Science
Country [1] 291824 0
Japan
Funding source category [2] 292084 0
Government body
Name [2] 292084 0
National Health and Medical Research Council
Country [2] 292084 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
Sydney NSW 2052
Country
Australia
Secondary sponsor category [1] 290487 0
Other
Name [1] 290487 0
Neuroscience Research Australia
Address [1] 290487 0
Barker Street Randwick Sydney NSW 2031
Country [1] 290487 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293342 0
Human Research Ethics Committee of the University of New South Wales
Ethics committee address [1] 293342 0
Sydney NSW 2052
Ethics committee country [1] 293342 0
Australia
Date submitted for ethics approval [1] 293342 0
Approval date [1] 293342 0
02/12/2014
Ethics approval number [1] 293342 0
HC14300

Summary
Brief summary
Step training has been recommended as a fall prevention strategy. However, it is possible that the repetitive step training in the forward and lateral direction might have negative effects for stepping ability in the diagonal (untrained) direction. Participants (45 adults 65+ years) will be asked to practice pre-administered exercise for 15 minutes in a single session. Baseline and post-intervention assessments will involve tests of stepping performance.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 59322 0
Dr Daina Sturnieks
Address 59322 0
Neuroscience Research Australia
Falls and Balance Research Group
Barker Street Randwick Sydney NSW 2031
Country 59322 0
Australia
Phone 59322 0
+612 9399 1062
Fax 59322 0
+61 2 9399 1204
Email 59322 0
[email protected]
Contact person for public queries
Name 59323 0
Dr Daina Sturnieks
Address 59323 0
Neuroscience Research Australia
Falls and Balance Research Group
Barker Street Randwick Sydney NSW 2031
Country 59323 0
Australia
Phone 59323 0
+612 9399 1062
Fax 59323 0
+61 2 9399 1065
Email 59323 0
[email protected]
Contact person for scientific queries
Name 59324 0
Dr Daina Sturnieks
Address 59324 0
Neuroscience Research Australia
Falls and Balance Research Group
Barker Street Randwick Sydney NSW 2031
Country 59324 0
Australia
Phone 59324 0
+612 9399 1062
Fax 59324 0
+61 2 9399 1065
Email 59324 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

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No documents have been uploaded by study researchers.

Documents added automatically
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