Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000910101p
Ethics application status
Submitted, not yet approved
Date submitted
6/06/2019
Date registered
28/06/2019
Date last updated
4/09/2019
Date data sharing statement initially provided
28/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Can motor imagery training improve strength and walking in older adults following discharge from rehabilitation?
Scientific title
The MITISAM study - Motor Imagery To Improve Strength And Mobility in older adults following discharge from rehabilitation: a randomised controlled trial
Secondary ID [1] 298395 0
None
Universal Trial Number (UTN)
U1111-1234-5921
Trial acronym
MITISAM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls 313088 0
Fracture 313089 0
Condition category
Condition code
Musculoskeletal 311573 311573 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 311574 311574 0 0
Physiotherapy
Injuries and Accidents 311575 311575 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Once discharged home, participants in the control group will receive standard in-home care as provided by the subacute facility and/or community rehabilitation therapists. Participants in the experimental group will undertake 15 minutes of guided motor imagery training five times per week for six weeks in addition to the standard in-home care provided by the community rehabilitation therapists. The guided motor imagery will be provided in the form of narrated audio files and are accompanied by brief 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 several strength and mobility related tasks such as squats 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 lower limb strength and walking 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] 314681 0
Treatment: Other
Intervention code [2] 314774 0
Rehabilitation
Comparator / control treatment
The control group will receive standard post-discharge care (standard care). Standard care typically involves community rehabilitation which is physiotherapy delivered one to two times per week in the home (or community centre). Participants will normally be prescribed a home exercise program to complete independently with standard care also.
Control group
Active

Outcomes
Primary outcome [1] 320326 0
Isometric Quadriceps strength using hand-held dynamometer
Timepoint [1] 320326 0
Baseline and 6 weeks post-discharge
Primary outcome [2] 320327 0
Isometric Calf strength using hand-held dynamometer
Timepoint [2] 320327 0
Baseline and 6 weeks post-discharge
Primary outcome [3] 320328 0
Timed up and Go (TUG) test to measure lower limb function
Timepoint [3] 320328 0
Baseline and 6 weeks post-discharge
Secondary outcome [1] 371259 0
Balance confidence - ABC 6
Timepoint [1] 371259 0
Baseline and 6 weeks post-discharge
Secondary outcome [2] 371260 0
Fear of falling - Fall efficacy scale international
Timepoint [2] 371260 0
Baseline and 6 weeks post-discharge
Secondary outcome [3] 371261 0
Functional independence measure
This assessment grades the functional status of a person based on the level of assistance required for dressing, walking stair etc.
Timepoint [3] 371261 0
Baseline and 6 weeks post-discharge
Secondary outcome [4] 371659 0
Kinesthetic and visual imagery questionnaire (KVIQ)
This questionnaire requires participants to physically perform a motor task then imagine themselves competing that same task. they then rate how vivid their imagined movement was.
Timepoint [4] 371659 0
Baseline and 6 weeks post-discharge

Eligibility
Key inclusion criteria
Adults aged at least 65 years undertaking a minimum of two weeks rehabilitation
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a 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; or 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)
Sealed opaque envelopes selected by participants in absence of investigators assessing outcome measures
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
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/03/2020
Actual
Date of last participant enrolment
Anticipated
30/10/2020
Actual
Date of last data collection
Anticipated
18/12/2020
Actual
Sample size
Target
34
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 13947 0
Brighton Health Campus - Brighton
Recruitment postcode(s) [1] 26715 0
4017 - Brighton

Funding & Sponsors
Funding source category [1] 302937 0
University
Name [1] 302937 0
Australian Catholic University
Country [1] 302937 0
Australia
Primary sponsor type
Hospital
Name
Brighton Health Campus
Address
449 Hornibrook Hwy, Brighton QLD 4017
Country
Australia
Secondary sponsor category [1] 302939 0
None
Name [1] 302939 0
Address [1] 302939 0
Country [1] 302939 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 303499 0
The Prince Charles Hospital HREC
Ethics committee address [1] 303499 0
Ethics committee country [1] 303499 0
Australia
Date submitted for ethics approval [1] 303499 0
11/07/2019
Approval date [1] 303499 0
Ethics approval number [1] 303499 0

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

Contacts
Principal investigator
Name 93874 0
Dr Vaughan Nicholson
Address 93874 0
School of Allied Health, Australian Catholic University, Brisbane
1100 Nudgee Rd, Banyo QLD 4014
Country 93874 0
Australia
Phone 93874 0
+61 7 36237687
Fax 93874 0
Email 93874 0
[email protected]
Contact person for public queries
Name 93875 0
Vaughan Nicholson
Address 93875 0
School of Allied Health, Australian Catholic University, Brisbane
1100 Nudgee Rd, Banyo QLD 4014
Country 93875 0
Australia
Phone 93875 0
+61 7 36237687
Fax 93875 0
Email 93875 0
[email protected]
Contact person for scientific queries
Name 93876 0
Vaughan Nicholson
Address 93876 0
School of Allied Health, Australian Catholic University, Brisbane
1100 Nudgee Rd, Banyo QLD 4014
Country 93876 0
Australia
Phone 93876 0
+61 7 36237687
Fax 93876 0
Email 93876 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?
all of the individual participant data 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?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
Access subject to approvals by Principal Investigator. Appropriate data will then be shared with the principal investigator via email or appropriate cloud storage.


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.