ReHabGame: a feasibility randomised controlled study of a markerless, Kinect-based game intervention versus standard physiotherapy to improve upper limb motor function in adults with neurological impairments

Ongoing (inferred)MS (type not specified)ISRCTN10134617

What it found

Still running

No result yet.

What it measured

Main measures

  • 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 met

    Arm and hand functionPhysical function

Other measures (1)

  • 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.

    Quality of life (reported by participants)SafetyFeasibility

Who could take part

MS (type not specified) · 18 to 110

Show the full criteria

Inclusion criteria

Inclusion: 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: 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

Exclusion criteria

Not separately supplied in the registry.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

Background and study aims ReHabGame is a research study exploring a fun and interactive way to support people who have difficulty moving their arm or hand due to a neurological condition like a stroke, brain injury, or multiple sclerosis. These conditions can make everyday tasks like eating, dressing, or writing more difficult, and traditional rehabilitation exercises can sometimes feel repetitive or boring. ReHabGame aims to make therapy more engaging by turning it into a game with rewards. Using a depth camera (Kinect), the system tracks the person’s movements without needing any wearable sensors. The player moves their arm or hand to control a virtual avatar on the screen, completing tasks like reaching, grasping, or pressing buttons. The game provides instant feedback and adapts to the person’s abilities, helping them improve. Who can participate? Adult patients (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. What does the study involve? In this study, participants will be invited to use ReHabGame for 6 to 8 weeks, attending two short sessions (each 30 min) per week. Their arm movement will be assessed before and after the program using a standard test, and again around 6 months later to see if any improvements last. The follow-up can be in-person or online over Microsoft Teams. They will also be asked how easy and enjoyable the game was and whether they would recommend it to others. This is a feasibility study, meaning its aim is to determine whether the game works well enough for real rehabilitation settings, how easy it is to participate in the study, and whether people like using it. The information gathered will help to design a larger study in the future. What are the possible benefits and risks of participating? ReHabGame has the potential to offer a motivating, low-cost, and home-friendly option for people working to regain their independence after neurological injury. Where is the study run from? Anglia Ruskin University (UK) When is the study starting and how long is it expected to run for? July 2024 to July 2027 Who is funding the study? Anglia Ruskin University (UK) Who is the main contact? Dr Shabnam Sadeghi Esfahlani, shabnam.sadeghi-esfahlani@aru.ac.uk

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History

    1. Started

      Jul 2025

    2. Finished

      Jul 2027

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