ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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 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]

Nil known

Universal Trial Number (UTN)

U1111-1191-7495

Trial acronym

Linked study record

Health condition

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

Elderly

Mobility

Condition category

Condition code

Physical Medicine / Rehabilitation

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]

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]

Timed to complete the Combined mobility task once

Timepoint [1]

Baseline and immediately after training or control session

Primary outcome [2]

Timed up and go

Timepoint [2]

Basleline and immediately after training or control session

Secondary outcome [1]

Imagined timed up and go

Timepoint [1]

Baseline and immediately after training or control session

Secondary outcome [2]

Gait variability is assessed on the GaitRite mat. The mat detects foot placements during gait.

Timepoint [2]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment postcode(s) [1]

4014 - Banyo

Funding & Sponsors

Funding source category [1]

University

Name [1]

Australian Catholic University

Address [1]

1100 Nudgee Road Banyo QLD 4014

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Australian Catholic University Human Research Ethics Committee

Ethics committee address [1]

Australian Catholic University
North Sydney Campus
PO Box 968
NORTH SYDNEY, NSW 2059

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

14/11/2016

Approval date [1]

03/01/2017

Ethics approval number [1]

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

Dr Vaughan Nicholson

Address

School of Physiotherapy
Australian Catholic University, Brisbane Campus
1100 Nudgee Rd Banyo QLD 4014

Country

Australia

Phone

+61 7 36237687

Fax

vaughan.nicholson@acu.edu.au

Contact person for public queries

Name

Vaughan Nicholson

Address

School of Physiotherapy
Australian Catholic University, Brisbane Campus
1100 Nudgee Rd Banyo QLD 4014

Country

Australia

Phone

+61 7 36237687

Fax

vaughan.nicholson@acu.edu.au

Contact person for scientific queries

Name

Vaughan Nicholson

Address

School of Physiotherapy
Australian Catholic University, Brisbane Campus
1100 Nudgee Rd Banyo QLD 4014

Country

Australia

Phone

+61 7 36237687

Fax

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.	Type	Citation	Link	Email	Other Details	Attachment
12208	Ethical approval			vaughan.nicholson@acu.edu.au

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically