Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001064998
Ethics application status
Approved
Date submitted
14/08/2020
Date registered
16/10/2020
Date last updated
12/12/2022
Date data sharing statement initially provided
16/10/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Motor Improvement in Neurological Conditions (MINC): Using a virtual dolphin to improve arm function in chronic stroke.
Scientific title
Motor Improvement in Neurological Conditions (MINC) :Using the MindPod video-game to improve arm function and cognition in chronic stroke survivors.
Secondary ID [1] 302036 0
None
Universal Trial Number (UTN)
U1111-1257-0030
Trial acronym
MINC: Chronic Stroke
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 318619 0
Condition category
Condition code
Stroke 316636 316636 0 0
Haemorrhagic
Stroke 316637 316637 0 0
Ischaemic
Physical Medicine / Rehabilitation 317082 317082 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 her arm. The system being used is the MindPod, designed by M-square health. Patients will train 20 times for 90 minutes time-on-task. The system is able to track the arm via a camera. Patients can be assigned to a group training 5 times a week (for 4 weeks), or another group training 3 times a week (for 6.67 weeks). Patients will wear an exoskeleton (EksoBionics) during training to provide anti-gravity support to their arms. This exoskeleton is like a backpack but then with arm supports. Training sessions will be supervised by researchers or trained students. Training takes place at ECU in Joondalup.

Difficulty level of the game and the amount of support by the exoskeleton 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. This results in individualisation of the training, that is the training is tailored to the level of function of each individual. 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. When that happens we know that the difficulty level of the game has to get adjusted. There are 27 difficulty levels we can chose from.

The exoskeleton is spring operated. We can chose 1 of 5 levels of spring stiffnesses, with higher spring levels providing more support. If the spring level is too low, then the patient will not be able to lift their arms up higher then 90 degrees of shoulder flexion. If that occurs, then we increase the spring level. Also, a higher spring level can be used if the patients indicates that she gets fatigued and is not able to lift up her arm to control the dolphin on the screen.

We will assess the compliance by number of sessions completed per patient.
Intervention code [1] 318331 0
Rehabilitation
Comparator / control treatment
We will conduct a dose comparison, that is we have two groups. One that trains 5 days a week, and one group that trains 3 times a week. This allows us to assess the effect of dosing.
Control group
Dose comparison

Outcomes
Primary outcome [1] 324757 0
Feasibility, assessed with compliance and number of sessions completed per patient..
Timepoint [1] 324757 0
Within 3 days after the last training session.
Primary outcome [2] 324758 0
Session duration, assessed by time taken to complete 90mins time-on task. The game shows the time-on-task in the left corner of the screen.
Timepoint [2] 324758 0
At the end of each training sessions.

Primary outcome [3] 324759 0
Adverse events, that is serious adverse events that lead to injury. There are no known adverse reactions to the intervention. We will write any adverse event in the logbook (for example a fall or any injury due to the intervention).
Timepoint [3] 324759 0
At the end of each training sessions.
Secondary outcome [1] 385687 0
Physical activity enjoyment scale (PACES): an overall enjoyment for physical activity score
Timepoint [1] 385687 0
Within 3 day after the last training session.
Secondary outcome [2] 385688 0
Arm function, assessed with the Fugl-Meyer upper extremity.
Timepoint [2] 385688 0
Two times at baseline, before the first training session, separated by at least one week, and within 3 days and a 1 month after the last training session.
Secondary outcome [3] 385689 0
Arm function, assessed with the Action Research Arm Test (ARAT).
Timepoint [3] 385689 0
Baseline and within 3 days and a 1 month after the last training session.
Secondary outcome [4] 385691 0
Movement kinematics, (including max angle, velocity, acceleration and workspace area of the arms) assessed with the KinArm exoskeleton.
Timepoint [4] 385691 0
Baseline and within 3 days and a 1 month after the last training session.
Secondary outcome [5] 385692 0
Grip strength, assessed with a handheld grip dynamometer.
Timepoint [5] 385692 0
Baseline and within 3 days and a 1 month after the last training session.
Secondary outcome [6] 385693 0
Quality of life assessment, assessed with the EQ-5D.
Timepoint [6] 385693 0
Baseline and within 3 day after the last training session.
Secondary outcome [7] 385694 0
Depression, assessed with the Depression Anxiety Stress Scale (DASS)
Timepoint [7] 385694 0
Baseline and within 3 day after the last training session.
Secondary outcome [8] 385695 0
Intrinsic motivation towards this intervention, assessed with the Intrinsic Motivation Inventory.
Timepoint [8] 385695 0
Baseline and within 3 day after the last training session.
Secondary outcome [9] 385696 0
Fatigue severity, assessed with the fatigue severity scale.
Timepoint [9] 385696 0
Baseline and within 3 day after the last training session.
Secondary outcome [10] 385697 0
Sleep quality, assessed with the Pittsburgh Sleep Quality Index (PSQI).
Timepoint [10] 385697 0
Baseline and within 3 day after the last training session.
Secondary outcome [11] 385698 0
Emotional status, assessed with the BEES (brief emotional experience survey)
Timepoint [11] 385698 0
Baseline and at 3 days and 1 month after the last training session.
Secondary outcome [12] 385699 0
Global disability, assessed with Modified Rankin Scale (MRS).
Timepoint [12] 385699 0
Baseline and within 3 days after the last training visit.
Secondary outcome [13] 387080 0
Physical status, assessed with the BEEPS ( Brief Physical Experience Scale)
Timepoint [13] 387080 0
At baseline and 3 days and 1 month after the last training session.
Secondary outcome [14] 407080 0
Qualitative questions around intervention acceptability and enjoyment. These will be audio-recorded either via a recorder or via videoconference (e.g. teams).
Timepoint [14] 407080 0
Within 3 days after the last training session.

Eligibility
Key inclusion criteria
1. Confirmed diagnosis of stroke
2. >6 months post stroke
3. Commitment to attend for all sessions
4. Ability to follow simple instructions
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Severe upper extremity pain
2. Fixed contraction
3. Neglect, that is a lack of awareness to one side of space
4. Require manual physical assistance
5. Aphasia, that is language production of comprehension issues

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We aim to randomise the participants by simple randomisation using coin-tossing. However due to the large time commitment 5 days a week is not always possible. These patients will then move to 3 days a week.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
In this feasibility study we aim to include at least 10 participants, that is 5 in each group. 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
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
23/10/2020
Actual
17/07/2020
Date of last participant enrolment
Anticipated
26/08/2022
Actual
13/09/2021
Date of last data collection
Anticipated
30/09/2022
Actual
Sample size
Target
10
Accrual to date
Final
4
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 306456 0
Charities/Societies/Foundations
Name [1] 306456 0
Multiple Sclerosis Society of Western Australia
Country [1] 306456 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
270 Joondalup Drive
Joondalup WA 6027
Australia
Country
Australia
Secondary sponsor category [1] 306977 0
None
Name [1] 306977 0
Address [1] 306977 0
Country [1] 306977 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306663 0
Edith Cowan University Human Research Ethics Committee
Ethics committee address [1] 306663 0
Ethics committee country [1] 306663 0
Australia
Date submitted for ethics approval [1] 306663 0
21/11/2019
Approval date [1] 306663 0
03/02/2020
Ethics approval number [1] 306663 0
2019-00873

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

Contacts
Principal investigator
Name 104602 0
Dr Onno van der Groen
Address 104602 0
Edith Cowan University
School of Medical and Health Sciences
270 Joondalup drive
Joondalup WA, 6027
Country 104602 0
Australia
Phone 104602 0
+61 863043644
Fax 104602 0
Email 104602 0
[email protected]
Contact person for public queries
Name 104603 0
Onno van der Groen
Address 104603 0
Edith Cowan University
School of Medical and Health Sciences
270 Joondalup drive
Joondalup WA, 6027
Country 104603 0
Australia
Phone 104603 0
+61 863043644
Fax 104603 0
Email 104603 0
[email protected]
Contact person for scientific queries
Name 104604 0
Onno van der Groen
Address 104604 0
Edith Cowan University
School of Medical and Health Sciences
270 Joondalup drive
Joondalup WA, 6027
Country 104604 0
Australia
Phone 104604 0
+61 863043644
Fax 104604 0
Email 104604 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.