Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000281796
Ethics application status
Approved
Date submitted
3/02/2021
Date registered
15/02/2022
Date last updated
12/12/2022
Date data sharing statement initially provided
15/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Motor Improvement in Neurological Conditions (MINC): Feasibility of using a virtual dolphin to influence arm function and cognition in multiple sclerosis.
Scientific title
Motor Improvement in Neurological Conditions (MINC): Feasibility of using the MindPod video-game to control arm function and cognition in people with multiple sclerosis.
Secondary ID [1] 303128 0
None
Universal Trial Number (UTN)
U1111-1263-5670
Trial acronym
MINC MindPod: Multiple Sclerosis
Linked study record

Health condition
Health condition(s) or problem(s) studied:
multiple sclerosis 320234 0
Condition category
Condition code
Neurological 318169 318169 0 0
Multiple sclerosis
Physical Medicine / Rehabilitation 318932 318932 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study consists of an immersive game where the patient has to control a dolphin on a 2D-screen with their arm. The system being used is the MindPod, designed by M-square health. The MindPod is able to track the movement of the patient's arm via a camera.

Patients will train 24 times for up to 60 minutes time-on-task (2 times per week for 12 weeks). Training sessions will be supervised by researchers or trained students. Training takes place at ECU in Joondalup or MSWA in Wilson.

3D movements of the arm control the movement of a virtual dolphin, swimming through different ocean scenes with various task goals including chasing and eating fish, eluding attacks, and performing jumps. Tasks are designed to promote movement in all planes throughout the active ranges of motion, and titrated based on successful completion of progressive levels of difficulty.
The difficulty level of the game will be adjusted on individual needs, that is through observation of the patient and based on the patient their feedback and how they progress through the different levels of the game. During the game, the patient has to catch fish with the dolphin and stay away from predators. If the level is too difficult, then the patient is not able to catch all fish, resulting in a game-over.

During each session we will determine fatigue levels with a visual analogue scale (VAS). If participants feel fatigued, for example classified on a 10-point as a visual analogue scale of 8 or higher , they will be offered an anti-gravity vest (Ekso Bionics, Richmond, CA) to allow participants to exercise for 60 minutes despite fatigue. The supervisor adjusts the level of support such that the target rate of perceived exertion (RPE) ranges between 5 and 8. The level of support can be adjusted by either changing the stiffness of the springs in the exoskeleton or removing the exoskeleton altogether.
Intervention code [1] 319426 0
Rehabilitation
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326171 0
Feasibility. One feasibility measure will include the recruitment rate as assessed by audit of the study database.
Timepoint [1] 326171 0
At conclusion of the study
Primary outcome [2] 326226 0
Retention rate will be determined to assess feasibility, as assessed by audit of study database
Timepoint [2] 326226 0
At conclusion of study.
Primary outcome [3] 326227 0
Feasibility would be assessed by assessing 4 key areas (process, resources, management, scientific, and acceptability) in feasibility trials in exercise in MS, as outlined previously (Learmonth and Motl, 2018). Questions are specifically designed for this study, based on the framework provided. These areas will be assessed with questionnaires and interviews for the participants and staff involved in the study. Participants have the option to answer the feasibility questions verbally in an interview or via videoconference. Answers will be recorded and transcribed for further analysis.
Timepoint [3] 326227 0
After each training session and within 3 days after the last training session.
Secondary outcome [1] 390357 0
Measure patterns of physical activity frequency, assessed by the Godin Exercise Leisure Time Questionnaire
Timepoint [1] 390357 0
Baseline, within 3 day after the last training session and 6 months after last session.
Secondary outcome [2] 390358 0
Visual analogue motivation towards exercise
Timepoint [2] 390358 0
After each training session
Secondary outcome [3] 390359 0
Exercise Self-efficacy questionnaire.
Timepoint [3] 390359 0
Baseline and within 3 days of last training session
Secondary outcome [4] 390360 0
PACES (Physical activity enjoyment scale)
Timepoint [4] 390360 0
Baseline & within 3 days of last training session
Secondary outcome [5] 390596 0
Intrinsic Motivation Inventory
Timepoint [5] 390596 0
Baseline & within 3 days of last training session
Secondary outcome [6] 390598 0
Depression Anxiety Stress Scale
Timepoint [6] 390598 0
Baseline, within 3 days of last training session and 6 months after last training session
Secondary outcome [7] 390599 0
Cognitive dysfunction assessed with the Symbol Digits Modality Test
Timepoint [7] 390599 0
Baseline, within 3 days of last training session and 6 months after last training session
Secondary outcome [8] 390600 0
Fatigue severity scale
Timepoint [8] 390600 0
Baseline, within 3 days of last training session and 6 months after last training session
Secondary outcome [9] 390601 0
Borg perceived exertion scale
Timepoint [9] 390601 0
After each training session
Secondary outcome [10] 390603 0
Quantify functional mobility, assessed with the Timed-up-and go test
Timepoint [10] 390603 0
Baseline, within 3 days of last training session and 6 months after last training session
Secondary outcome [11] 390604 0
Functional walk test (10m walk test)
Timepoint [11] 390604 0
Baseline, within 3 days of last training session and 6 months after last training session
Secondary outcome [12] 390605 0
Movement kinematics, (including max angle, velocity, acceleration and workspace area of the arms) assessed with the KinArm
Timepoint [12] 390605 0
Baseline, within 3 days of last training session and 6 months after last training session
Secondary outcome [13] 390606 0
Activities Balance Confidence Scale
Timepoint [13] 390606 0
Baseline & within 3 days of last training session
Secondary outcome [14] 390607 0
MSWS-12 (MS walking scale 12 self reported items on walking confidence)
Timepoint [14] 390607 0
Baseline, within 3 days of last training session and 6 months after last training session
Secondary outcome [15] 390608 0
Leeds MS Quality of life scale
Timepoint [15] 390608 0
Baseline, within 3 days of last training session and 6 months after last training session
Secondary outcome [16] 404214 0
Exercise intensity assessed with HR monitors
Timepoint [16] 404214 0
collected during each training session
Secondary outcome [17] 404215 0
Cognitive assessment with the KinArm exoskeleton
Timepoint [17] 404215 0
Baseline, within 3 days of the last training session, 6 months after the last training session
Secondary outcome [18] 404216 0
Arm function with the Action Research Arm Test
Timepoint [18] 404216 0
Baseline, within 3 days and 6 months after the last training sessions
Secondary outcome [19] 406272 0
DNA/RNA. This study is part of a larger observational research program where saliva samples will be collected for future analysis. Therefore, participants have the option to provide a saliva sample to collect their genetic material (DNA and RNA) for future exploratory analyses.
Timepoint [19] 406272 0
Baseline and within 3 days after the last training session

Eligibility
Key inclusion criteria
At least 18 years of age
Diagnosis of MS
PDDS score of >0 and <=3 (< or =) (measure of your MS severity)
stable medical treatment at least 1 month prior to the intervention;
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Already participating in exercise research
Diagnosis of another neurological illness or musculoskeletal disorder different to MS;
Diagnosis of a cardiovascular, respiratory, or metabolic illness or other conditions which may interfere with the study;
Suffering a flare-up, relapse or hospitalization in the last month prior to commencement of the assessment protocol or during the process of the therapeutic intervention;
Pregnancy.
The presence of a noncorrected visual disorders

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
In this feasibility study we aim to include up to 15 participants. This will give us enough data to then conduct a power calculation to determine sample sizes in future studies in this population.
We will use parametric testing if the requirements for these tests are met (eg normally distributed) or non-parametric if the requirements are not met. All alpha-values will be set to 0.05.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
14/03/2022
Actual
Date of last participant enrolment
Anticipated
1/02/2023
Actual
Date of last data collection
Anticipated
29/09/2023
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 307535 0
Charities/Societies/Foundations
Name [1] 307535 0
Multiple Sclerosis Society of Western Australia
Country [1] 307535 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
270 Joondalup Drive
Joondalup WA 6027
Australia
Country
Australia
Secondary sponsor category [1] 308213 0
None
Name [1] 308213 0
Address [1] 308213 0
Country [1] 308213 0
Other collaborator category [1] 281593 0
University
Name [1] 281593 0
Murdoch Univeristy
Address [1] 281593 0
90 South St
Murdoch WA 6150
Australia
Country [1] 281593 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307601 0
Edith Cowan University Human Research Ethics Committee
Ethics committee address [1] 307601 0
Ethics committee country [1] 307601 0
Australia
Date submitted for ethics approval [1] 307601 0
Approval date [1] 307601 0
18/01/2021
Ethics approval number [1] 307601 0
2020-01763

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

Contacts
Principal investigator
Name 107818 0
Dr Onno van der Groen
Address 107818 0
Edith Cowan University
School of Medical and Health Sciences
270 Joondalup drive
Joondalup WA, 6027
Country 107818 0
Australia
Phone 107818 0
+61 863043644
Fax 107818 0
Email 107818 0
[email protected]
Contact person for public queries
Name 107819 0
Kirsten van Rijn
Address 107819 0
Edith Cowan University
School of Medical and Health Sciences
270 Joondalup drive
Joondalup WA, 6027
Country 107819 0
Australia
Phone 107819 0
+61 863046977
Fax 107819 0
Email 107819 0
[email protected]
Contact person for scientific queries
Name 107820 0
Onno van der Groen
Address 107820 0
Edith Cowan University
School of Medical and Health Sciences
270 Joondalup drive
Joondalup WA, 6027
Country 107820 0
Australia
Phone 107820 0
+61 863043644
Fax 107820 0
Email 107820 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?
De-identified individual participant data underlying published results only, could be made available upon request or if the scientific journal request the data to be publicly available
When will data be available (start and end dates)?
Beginning 3 months after main publication, no end date determined
Available to whom?
Only 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 and the research team (dr. Onno van der Groen, [email protected])


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.