Neurological Condition: Diagnosed with stroke, traumatic brain injury (TBI), or multiple sclerosis (MS) that impacts upper-limb motor function. Nervous System Diseases
Conditions
Interventions
ReHabGame is a non-invasive, game-based digital therapeutic intervention designed to support upper-limb rehabilitation in individuals with neurological impairments (e.g., stroke, TBI, MS). It combines
Sponsors
Anglia Ruskin University
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion criteria
Inclusion criteria: 1. Adults (aged 18 years or older) diagnosed with a neurological condition, such as stroke, traumatic brain injury (TBI), or multiple sclerosis (MS), that affects upper-limb motor function. 2. To ensure sufficient functional ability to engage with the ReHabGame system, participants must meet at least one of the following objective inclusion criteria: 2.1. A Fugl-Meyer Assessment – Upper Extremity (FMA-UE) score between 20 and 50 (indicating mild-to-moderate impairment and sufficient voluntary movement) 2.2. A Box and Block Test score of =5 blocks per minute (demonstrating basic grasp-and-release function) 2.3. Active range of motion (AROM) of at least 10° in both shoulder and elbow flexion, or a Modified Ashworth Scale score of =3 at the elbow or wrist (to exclude those with severe spasticity that would hinder interaction). 3. Participants must be willing and able to commit to a 6–8 week game-based rehabilitation program (attending 1–2 sessions per week) 4. Have the capacity to provide informed consent, either independently or with support from a caregiver or legally authorised representative
Exclusion criteria
Exclusion criteria: 1. Medical Instability: Unstable cardiac, respiratory, orthopedic, or neurological conditions (e.g., uncontrolled seizures, severe arrhythmias) that pose a safety risk 2. Severe Motor Deficit: Complete paralysis (e.g., plegia) or extreme spasticity preventing meaningful interaction with the system 3. Contraindications to VR/Motion Tracking: Severe motion sickness, significant visual impairments, epilepsy triggered by visual stimuli, or other conditions making Kinect/VR usage unsafe 4. Concurrent Participation in Conflicting Studies: Currently enrolled in another interventional study or rehabilitation program that could confound results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Both quantitative (e.g., clinical assessments) and qualitative (e.g., questionnaire) methods will be employed to provide a comprehensive understanding of ReHabGame’s effectiveness and user experience: 1. Quantitative: 1.1. Clinical assessments: Standardised measures of arm function (e.g., Fugl-Meyer Assessment) at baseline, midpoint (if applicable), and post-intervention. 1.2. System-generated metrics: The ReHabGame software will record range-of-motion data, frequency of play, and task completion rates during sessions. 1.3. Observational checklists: Researchers may observe sessions to note participant posture, any difficulties using the system, and engagement level (e.g., exercise completion, verbal feedback during sessions). 2. Qualitative data collected from the web-based questionnaire. The research team will apply a structured coding framework (e.g., Braun & Clarke’s thematic analysis) to identify key themes around usability, motivation, and perceived impact. If needed, a qualitative data analysis tool (e.g., NVivo or MAXQDA) may be used to organise and manage transcripts. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcome measures will be used to evaluate the feasibility, acceptability, and preliminary clinical impact of the ReHabGame intervention via a questionnaire: 1. Feasibility is measured through recruitment rate, retention rate, session adherence, data completeness, and the occurrence of adverse events, using study screening logs, attendance records, and an adverse event log. These will be assessed continuously throughout the study and summarised at post-intervention (6–8 weeks). 2. Acceptability and user engagement are measured using automated gameplay metrics (e.g., frequency of use, task completion rates) collected at post-intervention (6–8 weeks) The measures will be collected at baseline, post-intervention (6–8 weeks), and 6-month follow-up, where feasible. | — |
Countries
England, United Kingdom
Contacts
Public ContactHassan Shirvani
Outcome results
None listed