Brain training to enhance balance in people with Parkinson's disease
Using Biofeedback During Exergaming to Attenuate Alpha Oscillations to Improve Postural Control in People Living With Parkinson's.
This study is testing a new virtual reality exercise program to see if it can help people with Parkinson's disease improve their balance and reduce falls.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Sex | All |
| Sponsor | University of Leicester Academic / other |
| Locations | 1 site (Leicester) |
| Trial ID | NCT05986643 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults with mild to moderate Parkinson's disease who have experienced falls and freezing of gait but can stand and walk unaided.
Not a fit: Patients with severe lower limb motor impairments, those requiring walking aids or wheelchairs, or individuals with a history of stroke or dementia may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance balance and reduce fall risk for individuals with Parkinson's disease, improving their overall quality of life.
How similar studies have performed: Previous studies have shown promise in using exercise and neurofeedback for rehabilitation, suggesting potential success for this innovative approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Leicester
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.