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Trial registered on ANZCTR

Registration number

ACTRN12619001784101

Ethics application status

Approved

Date submitted

3/09/2019

Date registered

17/12/2019

Date last updated

27/02/2023

Date data sharing statement initially provided

17/12/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Does four weeks of motor imagery training improve physical and perceived ability in older adults?

Scientific title

Does four weeks of motor imagery training improve physical and perceived ability of mobility and balance in older adults?

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1239-3137

Trial acronym

Linked study record

Health condition

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

Falls

Impaired balance

Condition category

Condition code

Physical Medicine / Rehabilitation

Physiotherapy

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

Musculoskeletal

Other muscular and skeletal disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Participants in the intervention group will undertake 15 minutes of guided motor imagery training five times per week for four weeks. The guided motor imagery will be provided in the form of narrated audio files and are accompanied by video clips of each task. The audio and video files will be uploaded onto a portable music player/tablet or the mobile phone of each participant and are set out as a schedule. A total of three or four tracks will be scheduled for each session to ensure each session is limited to 15 minutes. All imaging tasks and instructions are designed to get participants to imagine the movements from a first-person perspective and progress in difficulty during the program. The audio tracks will encourage participants to imagine themselves completing balance and mobility related tasks such as reaching and walking up stairs. Participants will be provided with an instruction booklet with a schedule of files to listen to on certain days and a checklist to monitor their progress during the program.
The motor imagery intervention was specifically designed for this study and target movements to improve balance and mobility tasks.
Adherence will be monitored in two ways: 1) by participants completing a training diary, 2) monitoring track/video views on the electronic device using device analytics.

Intervention code [1]

Rehabilitation

Intervention code [2]

Treatment: Other

Comparator / control treatment

No treatment will be provided to the control group. They will encouraged to continue with their everyday activities.

Control group

Active

Outcomes

Primary outcome [1]

Timed Up and Go (TUG) to assess mobility

Timepoint [1]

Baseline and 4 weeks

Primary outcome [2]

Imagined Timed Up and Go (iTUG) to assess perception of mobility

Timepoint [2]

Baseline and 4 weeks

Secondary outcome [1]

Gait speed assessed over 6 metres (at 3 differing widths - 15cm, 25cm and 50cm). The gait speed at differing widths are assessed as a composite measure. Measured with a stopwatch - time commences on the command 'go' and finishes when the participant reaches the end of the path.

Timepoint [1]

Baseline and 4 weeks

Secondary outcome [2]

Imagined gait speed over 6m (at differing widths - 15cm, 25cm and 50cm). The imagined gait speed at differing widths are assessed as a composite measure. Measured with a stopwatch - time commences on the command 'go' and finishes when the participant imagines them-self reaching the end of the path.

Timepoint [2]

Baseline and 4 weeks

Secondary outcome [3]

Step-over test .
Step over test height will be recorded in cm, the perceived step-over height will be determined by the participant by stating at what height they believe they could safely step over a bar.

Timepoint [3]

Baseline and 4 weeks

Secondary outcome [4]

The Short Activities-specific Balance Confidence (ABC-6) Scale: The ABC-6 will be used to assess balance confidence in participants at baseline and post-intervention. Participants are required to rate how confident they are that they would not lose balance when performing six tasks

Timepoint [4]

Baseline and 4 weeks

Secondary outcome [5]

Secondary outcomes
Kinesthetic and Visual Imagery questionnaire (KVIQ): The 10 item KVIQ will be used to assess the imagery ability of participants at baseline and post-intervention. Participants are required to perform a series of movements, then imagine performing that movement and then rate the clarity or intensity of their imagined movements. Score of 10-50 possible.

Timepoint [5]

Baseline and 4 weeks

Secondary outcome [6]

Perceived step-over test.
The perceived step-over height will be determined by the participant stating at what height they believe they could safely step over a bar.

Timepoint [6]

Baseline and four weeks

Secondary outcome [7]

Trail making test to assess executive function.

Timepoint [7]

Baseline and 4 weeks

Eligibility

Key inclusion criteria

aged 65-90 years, independent community dwelling and willing to be randomised and commit to the study requirements.

Minimum age

65 Years

Maximum age

90 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Acute or terminal illness, unstable or ongoing cardiovascular and/or respiratory disorder, neurological disease or impairment, joint replacement surgery in the past six months, or the inability to commit to a period of time equivalent to the duration of the study. Impaired vision that precludes them from seeing an object (bar) from 7m.

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 envelopes

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Permuted block randomisation

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

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Normality of distribution of the test measures will be confirmed using the Shapiro-Wilk test. Outcome measures will be presented as mean (standard deviation). Analysis will be based on intention-to-treat. Independent samples T-tests will determine whether any group difference exist at baseline in outcome measures and demographic data. Repeated measures ANOVA (between factors) will be used to identify differences between groups from baseline to follow-up (group*time) for the physical and imagined outcome measures together with the error or perception differences (ie. percentage difference between actual and imagined task). Differences between groups for balance confidence will also be assessed using a repeated measures ANOVA (between factors). The relationship between physical performance and balance confidence will be assessed using Pearson’s correlation coefficient.
Traditionally, in order to calculate the number of participants required for a study, power calculations would be performed based on previous similarly designed training studies that have assessed mobility in older adults. As there is a paucity of literature in terms of response to motor imagery in older adults and lack of consistency between outcome measures, it may be misleading to use previous motor imagery studies. As such, our sample size estimates will be based on previous motor imagery studies in stroke rehabilitation that have typically had 12-15 participants per group. For the proposed trial we aim to recruit 17 participants per group (34 in total) to account for a 10% drop-out rate. This sample size should allow for appropriate power to guide recommendations and inform future studies while still being small enough to be feasible in the short term.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/03/2020

Actual

1/03/2021

Date of last participant enrolment

Anticipated

30/10/2020

Actual

14/12/2021

Date of last data collection

Anticipated

18/12/2020

Actual

17/01/2022

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

The Prince Charles Hospital - Chermside

Recruitment postcode(s) [1]

4014 - Banyo

Recruitment postcode(s) [2]

4013 - Northgate

Recruitment postcode(s) [3]

4012 - Wavell Heights

Recruitment postcode(s) [4]

4032 - Chermside

Funding & Sponsors

Funding source category [1]

University

Name [1]

Australian Catholic University

Address [1]

1100 Nudgee Rd, Banyo, QLD 4014

Country [1]

Australia

Primary sponsor type

Individual

Name

Vaughan Nicholson

Address

School of Allied Health, Australian Catholic University, 1100 Nudgee Rd, 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 HREC

Ethics committee address [1]

8-20 Napier Street, North Sydney NSW 2060 Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

15/08/2019

Approval date [1]

29/10/2019

Ethics approval number [1]

2019-152HC

Summary

Brief summary

It is well established that with normal ageing come reductions in mobility, physical ability and associated functional performance. It has been identified that a mismatch between actual physical abilities and perceived physical ability are associated with increased falls risk and risk-taking behavior in older adults. This mismatch between physical and perceived abilities may be partly due to impairments in motor planning which commonly deteriorates with ageing. A simple way to measure the association between actual and perceived abilities is to compare the difference (error) in time or distance between actual and imagined (or perceived) performance. 

Motor imagery is the imagining of an action without its physical execution and can effectively improve motor skill and promote motor leaning as it activates areas of the brain that are normally activated during actual physical performance. Motor imagery has been shown to improve muscle strength and mobility, but it is not known whether motor imagery can influence the relationship between actual and perceived ability. 

The aim of this study is to identify whether four weeks of motor imagery training can improve physical abilities together with perception of motor abilities in older adults.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Vaughan Nicholson

Address

School of Allied Health, Australian Catholic University, 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 Allied Health, Australian Catholic University, 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 Allied Health, Australian Catholic University, 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?

Individual participant data collected during the trial, after de-identification that underlies published data

When will data be available (start and end dates)?

Immediately following publication, no end date

Available to whom?

Researchers who provide a methodologically sound proposal

Available for what types of analyses?

To achieve the aims in the approved proposal

How or where can data be obtained?

Access subject to approvals by Principal Investigator - provided in spreadsheet (de-identified data). These will be made available by emailing the principle investigator - vaughan.nicholson@acu.edu.au

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
4505	Study protocol			vaughan.nicholson@acu.edu.au
4506	Ethical approval					378256-(Uploaded-17-12-2019-09-53-08)-Study-related document.pdf

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.

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