Using Biofeedback During Exergaming to Attenuate Alpha Oscillations to Improve Postural Control in People Living With Parkinson's.

This is a multi-centre centre study with University of Leicester and DeMontfort University being research sites. NHS organisations will be PIC sites where participants will be identified from. No medical data or access to patient medical records will be made. A PIC mNCA will be in place with NHS organisations.

For the design of the study, the investigators will adopt a double-blinded randomised clinical trial. This means that patients will not know their group allocation and the research associate that will be analysing the data will also not know what treatment the patient received.

Participants will be allocated into either group 1 or 2. Participants in both groups will both perform the exergame rehabilitation. The exergame, delivered in virtual reality, involves travelling down a road (to give optic flow) whilst dodging balls that move towards the participant by either shifting their body either to the left or right. Patients are also be instructed to stand still and catch stars that appear, and these will be used to score points and are associated with reward, ensuring motivation.

This exergame has been specifically designed to combine aspects of movement and balance control, body position, aerobic fitness, strengthening of core muscles and elements of co-ordination and speed.

The difference between the two groups will be the neuro-feedback provided during the performance of the exercise game. That is, group 1 will receive real feedback of brain activity whilst group 2 will receive a placebo which is called SHAM feedback. This corresponds to a random recording that has no association/correlation with on-going brain (EEG) activity. All participants will be randomly assigned a unique key code via a random computer generator, this will be facilitated by the Data Monitoring and Ethics committee. The research technician, that will perform the analysis of the data, will not be privy to particular intervention of interest. After the random allocation, but before the intervention, all participants will receive a familiarisation procedure for their allocation. Once the participants have successfully undergone the eligibility screening (see section below for details), participants will be randomly allocated to one of two groups. The research team will then conduct the familiarisation sessions before proceeding to the pre-intervention assessment (limit of stability at baseline). This will be followed by the 12-week training program (that requires attendance at 30 1/2hr sessions over the course of three months. This will be followed by the 12 week (end of program) post-intervention assessment to measure the limit of stability, and a further single follow-up at 6 months to asses for long-term retention of any benefits. The 12-week post-intervention testing sessions will occur within 72 hours, but no less than 24 hours following the preceding training session. For the Pre-and Post- assessments: this will include the : (i) the Limits of Stability test, (ii) Sensory Organisation Test, (iii) Parkinson's Disease Questionnaire, (iv) Berg Balance Scale, (v) Section III of UPDRS, (vi) mBEST, (vii) 6 Metre WalkTest, (viii) 4 Square Step Test, and (ix) the Daily Activities Questionnaire. All of the aforementioned measures are openly available and do not require any licenses/permission to use. Accordingly, there will not be any need to share data with the license holders.