Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001577808
Ethics application status
Approved
Date submitted
23/09/2021
Date registered
18/11/2021
Date last updated
31/10/2022
Date data sharing statement initially provided
18/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Trial of gamification on physical therapy following Traumatic Brain Injury
Scientific title
Piloting the efficacy of gamification on outcomes from physical therapy after
traumatic brain injury: A single case experimental design case series
Secondary ID [1] 305364 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Traumatic Brain Injury 323705 0
Cardiorespiratory fitness 323706 0
Condition category
Condition code
Neurological 321237 321237 0 0
Other neurological disorders
Cardiovascular 321512 321512 0 0
Normal development and function of the cardiovascular system
Physical Medicine / Rehabilitation 321513 321513 0 0
Other physical medicine / rehabilitation
Injuries and Accidents 321514 321514 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single-case experiments will be conducted (N=10) within the Liverpool Brain Injury Rehabilitation Unit, testing the effectiveness of gamification technologies. These single-case experiments will be planned to ensure scientific rigor, using the Risk of Bias in N-of-1 Trials Scale. An A1-B1-A2-B2 withdrawal design will be employed with each phase lasting a fortnight. Each phase will commence immediately after the preceding phase with no wash out period to minimize changes associated with natural recovery and other rehabilitation interventions administered as part of routine care. Within each fortnight phase, three to eight fitness training therapy sessions will be delivered by a physiotherapist that are measured. The A 'baseline' phase will provide participants with usual feedback from the existing monitors on the gym equipment (e.g., the exercise bike, the treadmill). The B phase will be the intervention phase where feedback will employ virtual reality (VR) gamification strategies delivered by means of LCD monitors. Each session within the phases will typically last between 20-60 mins. Participants will be advised that a minimum requirement for each session is 20 minutes, however any further duration will be dependent on the participant’s ability and their motivational effort. The maximum number of sessions a participant can engage in per phase is eight to allow for phase-based outcome measures to be completed. While the aim is for participants to average approximately 5 sessions per phase, the minimum of 3 sessions is to account for unexpected reasons for missed sessions such as staffing, conflicting therapy/appointment/meeting and the participant feeling unwell.

For each participant, all sessions will be completed on the same fitness training modality, i.e., either the bike or the treadmill. The decision of whether the participant completes therapy sessions on the bike or treadmill will be determined as a joint decision between the participant and their treating physiotherapist. This will be based on participant preference as well as clinical suitability deemed by the treating physiotherapist based on an assessment of the participant’s safety to perform semi-supervised sessions on the bike or treadmill and the participant’s current functional ability.

The VR gamification will be non-immersive (i.e., without the use of VR goggles) and delivered by means of LCD monitors that will provide visual, interactive feedback to participants while they are conducting therapy sessions on the exercise bike or treadmill. The current monitors simply provide basic information about distance, steps and physiological parameters. The VR gamification will vary depending on the gym equipment. In the case of the bike exercises, the participant will see, on the monitor, a track that they are riding along, and they will be competing with other riders on the screen. The faster they pedal on the bike, the faster they ride along the track and the quicker they get to the finish line. In the case of the treadmill, the virtual environment may display a walk through the woods, with the person seeing more views if they walk more quickly.

Adherence to the intervention will be monitored using session attendance checklists recorded by the treating physiotherapist. These checklists will record number of sessions attended per phase and the duration of each session, extracted from a heart rate monitor in real-time that the participant will have turned on during the session.
Intervention code [1] 321774 0
Rehabilitation
Comparator / control treatment
Within the single-case experimental design, each participant acts as their own control. Participants undergo both the intervention and control treatments through a withdrawal A1-B1-A2-B2 design with each phase lasting a fortnight and including three to five fitness training therapy sessions that are measured.

The A phases will be the control which will be fitness training sessions on the recumbent bike or treadmill without the VR gamification, constituting usual care in the brain injury unit.
Control group
Active

Outcomes
Primary outcome [1] 329028 0
The amount of time in which participants work within their training zone (40-85% heart rate reserve).
Timepoint [1] 329028 0
During each session within in each A1-B1-A2-B2 phase
Secondary outcome [1] 401204 0
Exercise enjoyment - A purpose-designed 10-point visual analogue scale (anchors 0 Not enjoyable at all and 10 Most enjoyable ever) will be rated by the participant
Timepoint [1] 401204 0
At the end of each session within in each A1-B1-A2-B2 phase
Secondary outcome [2] 401206 0
6 Minute Walk Test (6MWT)
A widely-used self-paced submaximal test of functional capacity It measures the distance that the participant records walking on a flat, hard surface for 6 minutes. It is a continuous variable without ceiling effects
Timepoint [2] 401206 0
To be taken fortnightly at the start of A1, and then the end of A1, B1, A2, and B2.
Secondary outcome [3] 401208 0
10 Metre Walk Test (10MWT)
A performance measure used to assess walking speed and cadence. The participant is asked to walk at their preferred comfortable and fastest walking speed over a distance of 14 metres. The time taken to walk the middle 10 metres of a 14 metre walkway is timed to allow for acceleration and deceleration. Time (secs) and speed (10m x 60 secs / time = m/sec) is then recorded. A change is reflected by 0.15 and 0.25m/s increase in comfortable and fast-paced walking respectively
Timepoint [3] 401208 0
To be taken fortnightly at the start of A1, and then the end of A1, B1, A2, and B2.
Secondary outcome [4] 401209 0
Cardiovascular Fitness test - Peak heart rate
A peak fitness test specific to the modality utilised in the training session (i.e. bike or treadmill) to measure the participant’s peak cardiovascular capacity. It involves the
participant working at incremental increases in effort until they reach their peak effort or reach their predicted maximum heart rate (220-age) or if the test was terminated
due to criteria listed by the ACSM guidelines (ACSM, 2000).
Timepoint [4] 401209 0
To be taken fortnightly at the start of A1, and then the end of A1, B1, A2, and B2.
Secondary outcome [5] 402506 0
Cardiovascular Fitness test - Exercise test time
A peak fitness test specific to the modality utilised in the training session (i.e. bike or treadmill) to measure the participant’s peak cardiovascular capacity. It involves the
participant working at incremental increases in effort until they reach their peak effort or reach their predicted maximum heart rate (220-age) or if the test was terminated
due to criteria listed by the ACSM guidelines (ACSM, 2000).
Timepoint [5] 402506 0
To be taken fortnightly at the start of A1, and then the end of A1, B1, A2, and B2.
Secondary outcome [6] 402507 0
Cardiovascular Fitness test - maximal workload
A peak fitness test specific to the modality utilised in the training session (i.e. bike or treadmill) to measure the participant’s peak cardiovascular capacity. It involves the
participant working at incremental increases in effort until they reach their peak effort or reach their predicted maximum heart rate (220-age) or if the test was terminated
due to criteria listed by the ACSM guidelines (ACSM, 2000).
Timepoint [6] 402507 0
To be taken fortnightly at the start of A1, and then the end of A1, B1, A2, and B2.
Secondary outcome [7] 402508 0
Cardiovascular Fitness test - estimated VO2 peak for treadmill (calculated using equations validated in neurological population to compare to normative values)
A peak fitness test specific to the modality utilised in the training session (i.e. bike or treadmill) to measure the participant’s peak cardiovascular capacity. It involves the
participant working at incremental increases in effort until they reach their peak effort or reach their predicted maximum heart rate (220-age) or if the test was terminated
due to criteria listed by the ACSM guidelines (ACSM, 2000).
Timepoint [7] 402508 0
To be taken fortnightly at the start of A1, and then the end of A1, B1, A2, and B2.
Secondary outcome [8] 402509 0
duration of session - physiological measure collected through the heart rate monitor as a secondary measure of fitness
Timepoint [8] 402509 0
During each session within in each A1-B1-A2-B2 phase
Secondary outcome [9] 402510 0
maximum heart rate - physiological measure collected through the heart rate monitor as a secondary measure of fitness
Timepoint [9] 402510 0
During each session within in each A1-B1-A2-B2 phase
Secondary outcome [10] 402511 0
average heart rate - physiological measure collected through the heart rate monitor as a secondary measure of fitness
Timepoint [10] 402511 0
During each session within in each A1-B1-A2-B2 phase
Secondary outcome [11] 402512 0
kilocalories expended - physiological measure collected through the heart rate monitor as a secondary measure of fitness
Timepoint [11] 402512 0
During each session within in each A1-B1-A2-B2 phase


Eligibility
Key inclusion criteria
Inclusion criteria comprise: (i) having sustained a TBI; (ii) aged 18 years or over; (iii)
attending the LBIRU physiotherapy gym; (iv) who experience physical impairment (or
deconditioning) and (v) have a need for fitness training (vi) emerged from post-
traumatic amnesia (vi) able to do 10m walk test without assist (vii) clearance to
participate in a maximal fitness test as assessed through a pre-exercise screening
checklist and through consultation with the treating specialist.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria comprise: (i) Medical condition(s) precluding moderate to high
intensity exercise (unstable cardiac disease, uncontrolled hypertension, uncontrolled
metabolic diseases, large abdominal aortic aneurysm or a weight-bearing restriction)
in consultation with the treating specialist (ii) Insufficient English or language skills to
understand verbal instruction and feedback (iii) Cognitive impairment likely to
interfere with their ability to consistently participate in 30min bout fitness sessions on
a bike/treadmill (iv) Inadequate vision to interpret and understand the VR technology
and visual feedback (v) Anticipated management by LBIRU service for 8 weeks

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data from the primary and secondary outcomes will be evaluated for each individual separately, using both structured visual analysis, together with statistical techniques suitable for within-subject, time-series data. Structured visual analysis will use the standard protocol of Kratochwill et al. (2013). It will focus on six features of the data making both within- and between-phase comparisons for response level, trend, variability, immediacy, consistency, and overlap. The Tau-U technique will be used to statistically quantify overlap, and generate effect sizes.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/01/2022
Actual
21/01/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 20592 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 35381 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 309735 0
Hospital
Name [1] 309735 0
Liverpool Brain Injury Rehabilitation Unit
Country [1] 309735 0
Australia
Primary sponsor type
Hospital
Name
Liverpool Brain Injury Rehabilitation Unit
Address
Brain Injury Rehabilitation Unit,
Liverpool Hospital,
Elizabeth Street,
Liverpool, NSW, Australia 2170
Country
Australia
Secondary sponsor category [1] 310755 0
None
Name [1] 310755 0
Address [1] 310755 0
Country [1] 310755 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309492 0
South Western Sydney Local Health District HREC
Ethics committee address [1] 309492 0
Ethics committee country [1] 309492 0
Australia
Date submitted for ethics approval [1] 309492 0
Approval date [1] 309492 0
21/12/2020
Ethics approval number [1] 309492 0
2020/ETH02520

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

Contacts
Principal investigator
Name 114338 0
A/Prof Grahame Simpson
Address 114338 0
Ingham Institute
Liverpool Hospital
Locked Bag 7103
Liverpool BC NSW 1871
Country 114338 0
Australia
Phone 114338 0
+61 2 8738 5495
Fax 114338 0
Email 114338 0
[email protected]
Contact person for public queries
Name 114339 0
Grahame Simpson
Address 114339 0
Ingham Institute
Liverpool Hospital
Locked Bag 7103
Liverpool BC NSW 1871
Country 114339 0
Australia
Phone 114339 0
+61 2 8738 5495
Fax 114339 0
Email 114339 0
[email protected]
Contact person for scientific queries
Name 114340 0
Grahame Simpson
Address 114340 0
Ingham Institute
Liverpool Hospital
Locked Bag 7103
Liverpool BC NSW 1871
Country 114340 0
Australia
Phone 114340 0
+61 2 8738 5495
Fax 114340 0
Email 114340 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
All participant data will be deidentified and only reported at group level for the purposes of confidentiality for participants.


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.