Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000457246
Ethics application status
Approved
Date submitted
20/02/2018
Date registered
29/03/2018
Date last updated
17/06/2021
Date data sharing statement initially provided
8/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Can motor imagery improve strength during periods of restricted weight bearing in older adults?
Scientific title
Does the addition of motor imagery to standard physiotherapy care improve strength in older adults with restricted weight bearing within a rehabilitation setting?
Secondary ID [1] 294106 0
Nil known
Universal Trial Number (UTN)
U1111-1209-6138
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fracture 306696 0
Surgery 306697 0
Immobility in old age 306698 0
Ankle replacement 307014 0
Condition category
Condition code
Physical Medicine / Rehabilitation 305796 305796 0 0
Physiotherapy
Injuries and Accidents 305798 305798 0 0
Fractures
Physical Medicine / Rehabilitation 306110 306110 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Motor imagery (mental practice) plus standard physiotherapy care. Participants in the motor imagery group will undertake 15 minutes of motor imagery practice per day for four weeks. The motor imagery training will be guided by pre-recorded audio files uploaded onto a portable musci player. The audio files will be designed specifically for this study. The motor imagery tasks will relate to muscle contractions and everyday weight bearing movements. The training will be unsupervised, except for the first session when it will be supervised by a physiotherapist. Adherence will monitored by a patient diary and also by the number of times a track has been played on the audio device.
Standard physiotherapy care will follow proceures and guidelines of the facility. Standard physiotherapy care will typically involve strength and range of motion exercises along with targeted mobility and transfer training.
Intervention code [1] 300383 0
Rehabilitation
Intervention code [2] 300608 0
Treatment: Other
Comparator / control treatment
Participants in the control group will undertake standard physiotherapy care which will follow standard protocols of the facility and will not be influenced by the project. These guidelines relate to standard protocols aimed at improving strength, range of motion and independence in will involve strength and range of motion exercises along with targeted mobility and transfer training.
Control group
Active

Outcomes
Primary outcome [1] 304862 0
Isometric knee extension strength (measured with a digital hand-held dynamometer)
Timepoint [1] 304862 0
Baseline and four weeks
Primary outcome [2] 304863 0
Isometric plantar flexion strength (measured with a digital hand-held dynamometer)
Timepoint [2] 304863 0
Baseline and four weeks
Secondary outcome [1] 344300 0
Functional independence measure (FIM)
This will be assessed by facility staff as part of routine assessment
Timepoint [1] 344300 0
Baseline and pre-discharge
Secondary outcome [2] 377869 0
Grip strength assessed with a hand-held dynamometer
Timepoint [2] 377869 0
Baseline and four weeks

Eligibility
Key inclusion criteria
Aged 60 years or over
Prescribed restricted weight bearing or non-weight bearing for a minimum of one week due to injury or surgery
Resident of subacute rehabilitation facility.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any neurological condition likely to impair mobility such as Parkinson’s disease or Multiple sclerosis
A history of stroke or untreated heart disease
Impaired cognition (MMSE <24/30)
Profound hearing loss
Not willing or able to follow procedures specified by the study or instructions of the researcher.

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple computerised sequence generation
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
The sample size was calculated using G*Power software (version 3.1.9.2). The calculations were based on a repeated measures ANOVA (between-factors) with 2 treatment groups, 2 time periods (baseline and week two), an a value of 0.05, a power (ß) of 80%, with an ability to detect a medium effect size. This resulted in a desired sample size of 98 participants which represents 49 in each group. To account for 10% attrition, a target sample size of 108 participants (54 in each group) is required.
Repeated measures ANOVA will be used to identify differences in strength gained between groups from baseline to week four (primary endpoint)

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
14/01/2019
Actual
2/05/2019
Date of last participant enrolment
Anticipated
30/11/2021
Actual
Date of last data collection
Anticipated
30/12/2021
Actual
Sample size
Target
108
Accrual to date
6
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 10371 0
Brighton Health Campus - Brighton
Recruitment postcode(s) [1] 21597 0
4017 - Brighton Eventide
Recruitment postcode(s) [2] 22045 0
4017 - Brighton
Recruitment postcode(s) [3] 28803 0
4034 - Zillmere

Funding & Sponsors
Funding source category [1] 298742 0
Hospital
Name [1] 298742 0
Brighton Health Campus
Country [1] 298742 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
1100 Nudgee Road, Banyo, QLD 4014
Country
Australia
Secondary sponsor category [1] 297914 0
None
Name [1] 297914 0
None
Address [1] 297914 0
None
Country [1] 297914 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299681 0
The Prince Charles Hospital Human Research Ethics Committee
Ethics committee address [1] 299681 0
Ethics committee country [1] 299681 0
Australia
Date submitted for ethics approval [1] 299681 0
11/04/2018
Approval date [1] 299681 0
12/06/2018
Ethics approval number [1] 299681 0
HREC/18/QPCH/144

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

Contacts
Principal investigator
Name 81274 0
Dr Vaughan Nicholson
Address 81274 0
ACU School of Physiotherapy, Faculty of Health Sciences, 1100 Nudgee Road, Banyo, QLD, 4014
Country 81274 0
Australia
Phone 81274 0
+61 7 36237687
Fax 81274 0
Email 81274 0
[email protected]
Contact person for public queries
Name 81275 0
Vaughan Nicholson
Address 81275 0
ACU School of Physiotherapy, Faculty of Health Sciences, 1100 Nudgee Road, Banyo, QLD, 4014
Country 81275 0
Australia
Phone 81275 0
+61 7 36237687
Fax 81275 0
Email 81275 0
[email protected]
Contact person for scientific queries
Name 81276 0
Vaughan Nicholson
Address 81276 0
ACU School of Physiotherapy, Faculty of Health Sciences, 1100 Nudgee Road, Banyo, QLD, 4014
Country 81276 0
Australia
Phone 81276 0
+61 7 36237687
Fax 81276 0
Email 81276 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 relating to injury/diagnosis and strength and mobility measures collected during the trial, after de-identification.
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 and to be available for IPD meta-analyses.
How or where can data be obtained?
Access subject to approvals by Principal Investigator


What supporting documents are/will be available?

No Supporting Document Provided



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.