Table 1

The Rehabilitation via HOMe Based gaming exercise for the Upper-limb post Stroke (RHOMBUS) Template for Intervention Description and Replication (TIDieR)

TIDieR itemRHOMBUS intervention
1. Brief name: ‘provide the name or phrase that describes the intervention’Non-immersive virtual reality gaming exercise for upper-limb training poststroke
2. Why?: ‘describe any rationale, theory, or goal of the elements essential to the intervention’Rehabilitation for the arm poststroke is at best scant, with demand outstripping available resources; especially in the community setting where there is greater emphasis on the stroke survivor exercising independently.
Virtual reality (VR)-based activities have been suggested as an intervention to improve upper-limb recovery through providing a motivating treatment that helps to address problems with both boredom and compliance but is not reliant on increased time with a therapist.19 20
The average number of upper-limb repetitions completed in outpatient rehabilitation sessions conducted by both occupational therapists and physiotherapists has been shown to be as low as 45 repetitions.13 Repetition is known to be a key principle in driving neural plasticity in the learning and relearning of a task after brain damage.58 The use of video gaming to elicit purposeful upper-limb movements in stroke rehabilitation has also been shown to facilitate up to five times the number of purposeful movement repetitions per session as traditional therapy.59 VR training has been shown to facilitate longer active training time compared with conventional training.60 In this manner, the Neurofenix platform aims to promote high repetition active upper-limb movements through non-immersive VR video gaming.
3. What materials?: ‘describe any physical or informational materials used in the intervention, including those provided to participants or used in intervention delivery or in training of intervention providers. Provide information on where the materials can be accessed’The Neurofenix platform is used (www.neurofenix.com). The platform consists of non-immersive VR software and Bluetooth-connected hand and arm controllers for gamification of upper-limb stroke rehabilitation. The platform is a portable system that uses either a hand controller, the NeuroBall or elasticated arm bands, the NeuroBands. These allow all-in-one arm training through specifically designed rehabilitation games displayed on a tablet or laptop.
The NeuroBall: an innovative gaming controller which is spherical in shape allowing it to move freely on a base in all planes of movement, or to be held comfortably in both hands. The NeuroBall is secured to the impaired upper-limb hand through a system of straps and elastic finger holds. Motion sensors within the NeuroBall detect movements produced by the upper limb and translates these to control games on a tablet computer.
The NeuroBands: for those who do not have sufficient strength and range of movement in the hand and wrist to control the NeuroBall the NeuroBands are used as an alternative. The NeuroBands are two small motion sensors, the first straps around the upper arm and the second around either the forearm or the hand. If the second NeuroBand is placed on the forearm, then elbow flexion and extension can be trained, and if placed around the hand wrist flexion and extension can be used to control the games.
Bespoke rehabilitation games include Scuba Diver, Space Shooter, Pongoal, Holidays Jogging and adapted games such as Coin Frenzy, Pac Man and Solitaire. The games are controlled by the NeuroBall via movements of wrist flexion and extension (eg, in Scuba Diver, Pongoal), forearm pronation and supination (eg, SpaceShooter, Scuba Diver) and power grip (eg, Holidays Jogging). The same games can also be controlled by the NeuroBands through movements of elbow flexion and extension, shoulder flexion, extension (to neutral) internal and external rotation and wrist flexion and extension.
A handbook and ‘Quickstart’ page was produced to facilitate participants’ independent use of the Neurofenix platform. This contained key instructions of how to fit and use the NeuroBall and NeuroBands, how to navigate the menu and game screens, safe and comfortable use, individual game instructions and troubleshooting/help.
Study-specific documentation is used by the research therapists to record home visit sessions and a training checklist ensures all the content is covered. The software automatically measures activity data including game played, duration of play and number of repetitions performed.
The research therapists providing the Neurofenix platform training visit and following clinical and technical support received two half-days of specific training from Neurofenix. Neurofenix engineers are available for additional technical support if required.
4. What (procedures)?: ‘describe each of the procedures, activities and/or processes used in the intervention, including any enabling support activities’This study will examine the Neurofenix platform as an upper-limb exercise intervention over a 7-week intervention period. This commences with a training home visit followed by a 1-week training phase and a subsequent 6-week training phase.
The training home visit commences with a brief questionnaire about the participant’s prior experience with technology and video games and confidence in using new technology. This allows the research therapist to tailor the pace and depth of teaching based on the participant’s experience and confidence level. The participant will then be given the Neurofenix platform consisting of a NeuroBall or two NeuroBands, a tablet, a tablet stand, chargers and a handbook. A research therapist will then train the participant how to use the platform independently or with the help of a carer if requested.
Specifically, the participant will be trained in the following key activities: (1) how to turn the NeuroBall or NeuroBands and Tablet on and off, (2) safety precautions, (3) how to don the device, (4) calibrate the device, (5) how to use the device to play each of the games on the tablet, (6) how to navigate the menus, (7) how to track their progress, (8) how to use the handbook and (8) how to charge the devices.
The research therapist will monitor for discomfort, fatigue, eye strain, headache and increases in spasticity throughout the session. Participants will be advised to contact the research therapists using the contact details in the handbook for clinical and technical support throughout the intervention. At the end of the training home visit, the participant is encouraged to use the NeuroBall or NeuroBands for 5 days a week, gradually and safely increasing the amount of use with an aim to achieve 45 min a day by the end of the training week.
The participant will receive two scheduled phone calls from the research therapists 1 week and 3 weeks after the training home visit to ensure no clinical problems or technical faults have occurred. After this second follow-up telephone call, the participant will have no input from the research team unless the participant contacts the team for clinical or technical support. The participant will be called at the end of week 7 and asked to stop using the device on the final day of the 7-week intervention.
5. Who provided?: ‘for each category of intervention provider (for example, psychologist, nursing assistant) describe their expertise, background and any specific training given’The initial screening, physical screening, assessments and training home visits are all performed by the two research therapists who are registered physiotherapists.
The research therapists involved in the study received study-specific training on the assessments and intervention delivery.
6. How?: ‘describe the modes of delivery (such as face to face or by some other mechanism, such as Internet or telephone) of the intervention and whether it was provided individually or in a group’1:1 face-to-face delivery: Training home visit, unscheduled follow-up clinical and technical home visits (as required)
Telephone: Scheduled follow-up calls, unscheduled clinical and technical phone calls (as required)
Self-administered: NeuroBall or NeuroBand exercise throughout the 7-week intervention.
7. Where?: ‘describe the type of location(s) where the intervention occurred’Participants’ homes
8. When and how much?: ‘describe the number of times the intervention was delivered and over what period of time including the number of sessions, their schedule, duration, intensity or dose’The training home visit is provided at the participants’ preferred time usually requiring 1.5–2 hours. The participant will be encouraged to use the Neurofenix platform independently with an aim of 45 min a day, 5 days a week or more if they are able, self-limiting use based on fatigue and pain.
The Neurofenix platform records data on the game(s) played, the duration of the session and number of repetitions of upper-limb movements performed. The data are uploaded at the end of each session.
The participants will receive two scheduled follow-up phone calls to ensure they have not experienced clinical or technical difficulties. This will happen at the end of the training phase and 2 weeks into the exercise phase.
9. Tailoring: ‘If intervention was planned to be personalised or adapted, then describe what, why, when and how’If participants are assessed by the research therapists to have sufficient range of movement in the wrist and fingers to use the NeuroBall, they will be issued with this device. If they are unable to achieve a hand position compatible with using the NeuroBall, they will use the NeuroBands.
Once issued with their NeuroBall/NeuroBands, participants will independently decide the duration and frequency with which they use the device, as well as which games they choose to play.
To help guide participants on the duration and frequency of use, the research therapists will assess for signs of pain and fatigue during the training visit and give advice accordingly. During the intervention, the participant is responsible for how often or little they use the device and will not be prompted by the research therapists. The only exception will be if they are significantly overusing the device (>2 hours a day).
10. Modifications: ‘If intervention was modified during the course of the study, describe the changes what, why, when and how’There have been no modifications of the interventions to date.
11. How well (planned)?: ‘If intervention adherence or fidelity was assessed, describe how and by whom, and if any strategies were used to maintain or improve fidelity, describe them’Research therapists complete a training visit checklist to document content of instructions given to participants and to verify completion of home visits.
The Neurofenix platform records data on the game(s) played, the duration of the session and number of repetitions of upper-limb movements performed. The data are uploaded at the end of each session.
Usage data are updated and made available to the research therapists once a week to allow monitoring of participant adherence, but feedback based on this is only given to the participants if they are overusing the device.
12. How well (actual)?: ‘If intervention adherence or fidelity was assessed, describe the extent to which the intervention was delivered as planned’To be explored post hoc.