Exergame+Neurofeedback for Parkinson's (NCT05986643)
Improve balance with exercise feedback
- Trial ID
- NCT05986643
- Official Title
- Using Biofeedback During Exergaming to Attenuate Alpha Oscillations to Improve Postural Control in People Living With Parkinson's.
- Goal
- Improve balance with exercise feedback
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- University of Leicester
- Study Type
- INTERVENTIONAL
- Enrollment
- 100 participants
- Conditions
- Parkinson Disease
- Interventions
- Exergame+Neurofeedback, Exergame [alone]
Summary For Families
The goal is to help people with Parkinson's improve balance and cut down on falls, because balance problems get worse over time and falling lowers quality of life and raises health risks. The approach uses a virtual-reality exercise game where you shift your body to dodge balls and stand still to catch stars, combining balance, core work, coordination and fitness; during the game one group gets real-time feedback from their brain signals aimed at lowering a specific brain rhythm called alpha, while the other group gets a sham random feedback, and both do thirty 30-minute sessions over 12 weeks. They are looking for adults with Parkinson's who can stand and walk without a walking aid, who do less than the recommended aerobic exercise, who have had at least one fall and one freezing episode in the past year, and who are on a stable Parkinson's medication dose or not expected to start treatment soon.
Locations
- University of Leicester, Leicester, United Kingdom
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Exergame+Neurofeedback. The goal is to help people with Parkinson's improve balance and cut down on falls, because balance problems get worse over time and falling lowers quality of life and raises health risks. The approach uses a virtual-reality exercise game where you shift your body to dodge balls and stand still to catch stars, combining balance, core work, coordination and fitness; during the game one group gets real-time feedback from their brain signals aimed at lowering a specific brain rhythm called alpha, while the other group gets a sham random feedback, and both do thirty 30-minute sessions over 12 weeks. They are looking for adults with Parkinson's who can stand and walk without a walking aid, who do less than the recommended aerobic exercise, who have had at least one fall and one freezing episode in the past year, and who are on a stable Parkinson's medication dose or not expected to start treatment soon.
- Who can participate?
- Eligibility criteria vary. Check the full listing on ClinicalTrials.gov for detailed inclusion and exclusion criteria.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 3 years and 4 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- This trial has 2 groups, and 1 is a sham (a pretend version of the procedure) group. Because assignment is random, you have about a 1 in 2 chance (roughly 50%) of being in the sham group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.
- How many visits does this trial involve?
- You will attend 30 half-hour training sessions over a 12-week (three-month) program, plus a pre-intervention (baseline) assessment and post-intervention assessments including a follow-up at 6 months.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Brain wave recording (EEG) (non-invasive); Questionnaires & surveys (non-invasive). Confirm the full schedule with the study coordinator.