Rehabilitation using virtual gaming for Hospital and HOMe-Based Upper-limb exercise post Stroke (RHOMBUS II): a feasibility randomized controlled trial
Stroke
Following baseline assessments participants will be randomly allocated to the intervention or usual care group in a 2:1 ratio. An individual independent of the study will generate a sequence using permuted blocks of randomly chosen size three or six. The allocation sequence will be placed in opaque, sealed envelopes. Following each baseline assessment, an envelope will be drawn sequentially by the research assistant who will inform the participant if they are in the intervention or control group. NeuroBall + usual care study arm: The NeuroBall intervention is described in detail elsewhere using the Template for Intervention Description and Replication (TIDieR) (Kilbride et al 2018b). In summary, the NeuroBall is a non-immersive virtual reality digital platform in the form of an app on a computer tablet designed for upper limb stroke rehabilitation. The device is a portable sensor-enabled hand controller that tracks arm and hand movements and provides extrinsic feedback on a stroke survivor’s exercise session through an artificial intelligence (AI) enabled analytics dashboard. The device can be used to promote the specific practice of unilateral or bilateral movements in the shoulder, elbow, wrist and hand through uniquely designed games displayed on a tablet computer. The NeuroBall software automatically measures activity data including game played, duration of play and the number of repetitions performed. Data is automatically sent via secure transmission to the bioengineers at Neurofenix. Each participant in the intervention group will be provided with their own NeuroBall for personal use for 7 weeks (including training/familiarisation time). The device can be used both as an adjunct to therapy led rehabilitation and for self-directed exercise outside of timetabled therapy sessions. Participants will be encouraged to slowly increase their use of the device towards the minimum national daily target of 45 minutes (this can be achieved in short, frequent session
Stroke survivors: 1. Aged 18 years or over 2. Clinically confirmed acute stroke with new unilateral weakness 3. Able to provide consent to take part in the study and to comply with the requirements of the protocol 4. Motricity Index score between 9-25 for elbow (from 90 flexion) and/or shoulder movement (shoulder abduction) 5. Ability to communicate in English, sufficient for completion of the trial intervention and assessment 6. Able to see the graphics and visual display on the screen Members of the healthcare team (stroke unit or early stroke supported discharge team): 1. Aged 18 years and over 2. Participated in the delivery of the intervention 3. Provided informed consent
Stroke survivors: 1. Unstable medical conditions 2. Unable to follow a two-stage command 3. Uncontrolled photosensitive epilepsy 4. Shoulder/arm pain exacerbated on movement 5. Already participating in an upper limb rehabilitation trial 6. Patients with significant cognitive impairment and unable to comprehend and follow all instructions relating to participation in the study 7. Care home residents