Brain training to enhance balance in people with Parkinson's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project aims to improve balance and reduce falls in individuals with Parkinson's disease through a novel exercise program that alters brain activity. Participants will engage in a virtual reality exergame designed to enhance movement, balance control, and coordination while receiving neurofeedback on their brain activity. The study will utilize a double-blinded randomized clinical trial design, ensuring that neither participants nor data analysts know the treatment allocation. The goal is to determine if the combination of exercise and neurofeedback leads to better outcomes in balance and quality of life for patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

People with Parkinson with mild-moderate disease and severe disability (but able to stand and walk unaided (Hoehn and Yahr stage ≤4) be eligible if:

* in everyday life, they do less than the recommended aerobic exercise for older adults (i.e., vigorous exercise done \<3 times per week, 20 min per session; or moderate exercise done \<5 times per week, 30 min per session).
* they have experienced at least one fall and one episode of freezing of gait in the past year.
* they are taking stable dopaminergic pharmacotherapy (stable dose for at least 1 month) or are still without treatment and not expected to start treatment within the next 3 months.

As long as all criteria are met - we will not impose any lower (assuming they are adults) or upper age limit for recruitment.

Exclusion Criteria:

* severe lower limb motor impairments and/or requirement of a walking aid or wheelchair
* previously diagnosed with stroke or dementia
* having metal implants in the head (i.e. deep brain stimulator or aneurysm clips)
* any other known medical, mental health, or physical condition which may interfere with balance.
* patients on beta-blocking agents or antipsychotics
* patients with other neurological, orthopaedic, or cardiac co-morbidities that make them unfit to do exercise or interferes with balance and cognitive functions required to participate in this study
* patients with psychiatric diseases diagnosed in the past year by a psychiatrist
* patients with dementia
* those unable to tolerate the exergame task.

Where it's running

• University of Leicester
  Leicester, United Kingdom Recruiting

Study contacts

• Principal investigator: Qadeer Arshad — University of Leicester
• Study coordinator: Yasmin Godhania
• Email: RGOsponsor@leicester.ac.uk
• Phone: 0116 373 6039

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.