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Trial of gamification on physical therapy following Traumatic Brain Injury

Piloting the efficacy of gamification on outcomes from physical therapy after traumatic brain injury: A single case experimental design case series

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001577808
Enrollment
5
Registered
2021-11-18
Start date
2022-01-21
Completion date
Unknown
Last updated
2022-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Reduced cardiorespiratory fitness is a common secondary impairment for people who have sustained a severe traumatic brain injury (TBI). Gamification including virtual reality (VR) may be one strategy to provide a motivating environment for fitness training. A recent large randomised controlled trial (n=300; including 18 adults with severe TBI) conducted by members of the research team, provided additional rehabilitation using digital devices and demonstrated improvements in mobility and self-reported physical activity at 6-months and cognition at 3 weeks. Fitness training and virtual reality has been investigated in people after TBI by one single group study conducted over 20 years ago. In this study, 13 people with severe TBI underwent 4 weeks of fitness training on a cycle ergometer using VR. This study showed promising results in cognitive changes, but no follow up work was conducted. Given the improved knowledge in dosage and benefits of fitness training in this population, and the growing interest and access to virtual reality systems, a pilot study focused on how best to implement this type of program in practice is warranted. This study will evaluate the efficacy of gamification on outcomes from fitness training using a single-case experimental design protocol with a group of patients from the Liverpool Brain Injury Rehabilitation Unit who require physical rehabilitation after TBI.

Interventions

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 r

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.

Sponsors

Liverpool Brain Injury Rehabilitation Unit
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026