Trial Review

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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] 299125 0
None
Universal Trial Number (UTN)
U1111-1239-3137
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls 314193 0
Impaired balance 314194 0
Condition category
Condition code
Physical Medicine / Rehabilitation 312548 312548 0 0
Physiotherapy
Physical Medicine / Rehabilitation 312549 312549 0 0
Other physical medicine / rehabilitation
Musculoskeletal 312550 312550 0 0
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] 315397 0
Rehabilitation
Intervention code [2] 315398 0
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] 321258 0
Timed Up and Go (TUG) to assess mobility
Timepoint [1] 321258 0
Baseline and 4 weeks
Primary outcome [2] 321259 0
Imagined Timed Up and Go (iTUG) to assess perception of mobility
Timepoint [2] 321259 0
Baseline and 4 weeks
Secondary outcome [1] 374469 0
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] 374469 0
Baseline and 4 weeks
Secondary outcome [2] 374470 0
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] 374470 0
Baseline and 4 weeks
Secondary outcome [3] 374472 0
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] 374472 0
Baseline and 4 weeks
Secondary outcome [4] 374473 0
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] 374473 0
Baseline and 4 weeks
Secondary outcome [5] 374474 0
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] 374474 0
Baseline and 4 weeks
Secondary outcome [6] 375238 0
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] 375238 0
Baseline and four weeks
Secondary outcome [7] 419044 0
Trail making test to assess executive function.
Timepoint [7] 419044 0
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
50
Accrual to date
Final
53
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 15091 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 27746 0
4014 - Banyo
Recruitment postcode(s) [2] 27747 0
4013 - Northgate
Recruitment postcode(s) [3] 27748 0
4012 - Wavell Heights
Recruitment postcode(s) [4] 28389 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 303666 0
University
Name [1] 303666 0
Australian Catholic University
Country [1] 303666 0
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] 303769 0
None
Name [1] 303769 0
Address [1] 303769 0
Country [1] 303769 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304187 0
Australian Catholic University HREC
Ethics committee address [1] 304187 0
Ethics committee country [1] 304187 0
Australia
Date submitted for ethics approval [1] 304187 0
15/08/2019
Approval date [1] 304187 0
29/10/2019
Ethics approval number [1] 304187 0
2019-152HC

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96082 0
Dr Vaughan Nicholson
Address 96082 0
School of Allied Health, Australian Catholic University, 1100 Nudgee Rd Banyo, QLD 4014
Country 96082 0
Australia
Phone 96082 0
+61 7 36237687
Fax 96082 0
Email 96082 0
[email protected]
Contact person for public queries
Name 96083 0
Vaughan Nicholson
Address 96083 0
School of Allied Health, Australian Catholic University, 1100 Nudgee Rd Banyo, QLD 4014
Country 96083 0
Australia
Phone 96083 0
+61 7 36237687
Fax 96083 0
Email 96083 0
[email protected]
Contact person for scientific queries
Name 96084 0
Vaughan Nicholson
Address 96084 0
School of Allied Health, Australian Catholic University, 1100 Nudgee Rd Banyo, QLD 4014
Country 96084 0
Australia
Phone 96084 0
+61 7 36237687
Fax 96084 0
Email 96084 0
[email protected]

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 - [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4505Study protocol  [email protected]
4506Ethical 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.