Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000122358
Ethics application status
Approved
Date submitted
17/01/2017
Date registered
24/01/2017
Date last updated
23/06/2021
Date data sharing statement initially provided
23/06/2021
Date results information initially provided
23/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Can thinking about movement improve movement speed in older adults?
Scientific title
Motor learning with motor imagery training: within session effects of motor imagery training in healthy older adults
Secondary ID [1] 290941 0
Nil known
Universal Trial Number (UTN)
U1111-1191-7495
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Elderly 301670 0
Mobility 301671 0
Condition category
Condition code
Physical Medicine / Rehabilitation 301378 301378 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1:
Kinesthetic motor imagery
Participants will be instructed to imagine themselves performing a previoulsy performed mobility task. The mobility task involves getting out of a chair, walking 10m, stepping over a step, going through a series of markers that require small changes of direction, then turning around 90 degrees, returning through markers, over step, walk a further 10m and return to sitting. This task includes a number of mobility related components essential for safe ambulation in older adults.
Participants will perform 20 imagined repetitions of a the mobility task over a period of 20 minutes with a 30second rest between each repetition. All repetitions will be completed within a single session.
Motor imagery training will be supervised by a physiotherapist with over 10 years experience

Arm 2:
Physical practice
Participants will be instructed to physically perform the combined mobility task. The mobility task involves getting out of a chair, walking 10m, stepping over a step, going through a series of markers that require small changes of direction, then turning around 90 degrees, returning through markers, over step, walk a further 10m and return to sitting. This task includes a number of mobility related components essential for safe ambulation in older adults.
Participants will perform 20 repetitions of the mobility task over a period of approximately 20minutes, with 30 seconds rest between repetitions. All repetitions will be completed within a single session.
The physical practice will be supervised by a physiotherapist with over 10 years experience
Intervention code [1] 296880 0
Treatment: Other
Comparator / control treatment
They will be occupied watching/playing on an electronic device (iPad) for the equivalent time (~20minutes) as those involved in the motor imagery and physical training. Participants can choose from a small selection of games that require them to complete maths or language based problems. As such they will be required to concentrate but it is not anticipated to have any treatment value.
Control group
Placebo

Outcomes
Primary outcome [1] 300771 0
Timed to complete the Combined mobility task once
Timepoint [1] 300771 0
Baseline and immediately after training or control session
Primary outcome [2] 300772 0
Timed up and go
Timepoint [2] 300772 0
Basleline and immediately after training or control session
Secondary outcome [1] 330825 0
Imagined timed up and go
Timepoint [1] 330825 0
Baseline and immediately after training or control session
Secondary outcome [2] 343430 0
Gait variability is assessed on the GaitRite mat. The mat detects foot placements during gait.
Timepoint [2] 343430 0
Baseline and immediately after training or control session

Eligibility
Key inclusion criteria
independently mobile
can commit to the study time frames
Minimum age
65 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
any falls in the past 12 months
require a walking aid for indoor mobility
acute or terminal illness
unstable cardiovascular and/or respiratory disorder
neurological disease
joint replacement in the past six months.

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)
Sealed opaque envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is a feasability study that will inform sample size calculations for furture interventions.
Analysis of variance will be used to determine whether changes from baseline to follow-up assessment are different between groups for primary outcome variables

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2017
Actual
7/02/2017
Date of last participant enrolment
Anticipated
27/06/2017
Actual
20/07/2017
Date of last data collection
Anticipated
30/06/2017
Actual
1/08/2017
Sample size
Target
20
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 15109 0
4014 - Banyo

Funding & Sponsors
Funding source category [1] 295359 0
University
Name [1] 295359 0
Australian Catholic University
Country [1] 295359 0
Australia
Primary sponsor type
Individual
Name
Vaughan Nicholson
Address
School of Physiotherapy
Australian Catholic University
1100 Nudgee Road Banyo QLD 4014
Country
Australia
Secondary sponsor category [1] 294184 0
None
Name [1] 294184 0
Address [1] 294184 0
Country [1] 294184 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296691 0
Australian Catholic University Human Research Ethics Committee
Ethics committee address [1] 296691 0
Australian Catholic University
North Sydney Campus
PO Box 968
NORTH SYDNEY, NSW 2059
Ethics committee country [1] 296691 0
Australia
Date submitted for ethics approval [1] 296691 0
14/11/2016
Approval date [1] 296691 0
03/01/2017
Ethics approval number [1] 296691 0
2016-285H

Summary
Brief summary
Motor imagery is an imagining of an action without its physical execution; it is a dynamic state during which the representation of a given motor act is internally rehearsed or imagined within working memory without any overt muscle activation. Motor imagery activates brain regions that are activated during actual task performance and motor imagery training has been found to improve task performance. Motor imagery has been found to improve static balance in the elderly but its effect on dynamic balance or functional performance in older adults is unknown. The aim of this study is to determine whether imagining certain movements repeatedly promotes improvements in mobility. It is hypothesised that motor imagery will improve mobility but a point of diminishing gains will occur after multiple repetitions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71794 0
Dr Vaughan Nicholson
Address 71794 0
School of Physiotherapy
Australian Catholic University, Brisbane Campus
1100 Nudgee Rd Banyo QLD 4014
Country 71794 0
Australia
Phone 71794 0
+61 7 36237687
Fax 71794 0
Email 71794 0
vaughan.nicholson@acu.edu.au
Contact person for public queries
Name 71795 0
Dr Vaughan Nicholson
Address 71795 0
School of Physiotherapy
Australian Catholic University, Brisbane Campus
1100 Nudgee Rd Banyo QLD 4014
Country 71795 0
Australia
Phone 71795 0
+61 7 36237687
Fax 71795 0
Email 71795 0
vaughan.nicholson@acu.edu.au
Contact person for scientific queries
Name 71796 0
Dr Vaughan Nicholson
Address 71796 0
School of Physiotherapy
Australian Catholic University, Brisbane Campus
1100 Nudgee Rd Banyo QLD 4014
Country 71796 0
Australia
Phone 71796 0
+61 7 36237687
Fax 71796 0
Email 71796 0
vaughan.nicholson@acu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
ending 5 years following main results publication
Available to whom?
researchers who provide a methodologically sound proposal
Available for what types of analyses?
any purpose
How or where can data be obtained?
access subject to approvals by Principal Investigator - vaughan.nicholson@acu.edu.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12208Ethical approval  vaughan.nicholson@acu.edu.au



Results publications and other study-related documents

Documents added manually

Documents added automatically
No additional documents have been identified.