RecruitingNAINTERVENTIONAL

Brain Training to Improve Balance in Parkinson's Disease

Living with Parkinson's can often mean facing challenges with balance, which can lead to falls and affect daily life. This study aims to find new and better ways to help people with Parkinson's disease improve their balance and reduce the risk of falling. Researchers are investigating whether a special exercise game, combined with 'brain training' (neurofeedback), can change brain activity and lead to better balance. Participants will be split into two groups: one will play the exercise game with real-time brain feedback, and the other will play the game with a dummy feedback. Both groups will attend sessions three times a week for 12 weeks. Researchers will compare how effectively each method improves balance before and after the study.

At a glance

Status

Recruiting

Phase

Sponsor

University of Leicester

Enrolment target

100

Start

04 Aug 2023

Estimated completion

01 May 2027

Parkinson Disease

What is this study about?

Balance problems are a major concern for many people living with Parkinson's disease, often making daily activities difficult and increasing the risk of falls. Falls can lead to injuries like fractures and significantly impact a person's quality of life. Because of this, doctors and researchers are always looking for new and effective treatments to help improve balance and prevent falls.

This study looks at a new approach using a special exercise game, sometimes called an 'exergame.' This game works in a virtual reality setting, asking you to move and react to things on screen. The interesting part is that some participants will also get 'brain training' while they play. This 'brain training,' or neurofeedback, aims to help you learn to change your brain activity, similar to how concentrating on your breathing can help you relax. Researchers want to see if combining this specific exercise game with brain training can lead to even better improvements in balance for people with Parkinson's.

The study will involve two groups of participants, chosen randomly. One group will play the exercise game along with real brain training, while the other group will play the same game but with a 'dummy' brain feedback that doesn't actually reflect their brain activity. This helps researchers understand which part of the treatment is truly making a difference. Everyone will attend regular sessions, and researchers will measure their balance before and after the study to see which method works best.

Key takeaways

Aims to improve balance and reduce falls for people with Parkinson's.
Tests an exercise game combined with 'brain training' (neurofeedback).
Involves 12 weeks of regular, half-hour exercise sessions.
Compares real brain training with a dummy version of brain training.
Could lead to new ways to manage Parkinson's symptoms.
Participation helps future research and understanding of Parkinson's.

Who may be eligible?

To be considered for this study, you would need to have Parkinson's disease that is mild to moderate, but also causes significant disability. You should be able to stand and walk on your own without help. You must also have fallen at least once in the past year and experienced 'freezing of gait' (where your feet briefly feel stuck to the floor). If you're currently taking medication for Parkinson's, your dose should have been stable for at least a month, or you shouldn't be expected to start new medication in the next three months. We are looking for people who don't already get much aerobic exercise.

There are also some reasons why you might not be able to join. For example, if you need a walking aid or wheelchair, or if you've had a stroke or dementia. People with metal implants in their head, like a deep brain stimulator, or who are taking certain medications like beta-blockers or antipsychotics, would also not be able to participate. If you have other serious health conditions that affect your balance, ability to exercise, or thinking skills, you might also not be suitable for this study.

This study is open to adults of any age, as long as they meet the other requirements. The main idea is to make sure participants are safe and can fully take part in the exercise game and training.

Quick self-check

Do you have mild to moderate Parkinson's disease?
Can you stand and walk on your own without help?
Have you fallen at least once in the last year?
Do you experience 'freezing of gait'?
Do you currently get less than the recommended amount of aerobic exercise?
Are you able to manage using a virtual reality exercise game?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you will be randomly placed into one of two groups. Both groups will take part in physical therapy involving a special exercise game. You'll attend three sessions per week, with each session lasting about 30 minutes. This will continue for a total of 12 consecutive weeks, meaning you'll attend around 36 sessions. Over each two-week period, you're expected to attend 5 sessions.

Before you start the exercise program, and again after you finish, researchers will carry out assessments to measure your balance and other related abilities. This helps them understand if and how much your balance has improved. You won't need to change any regular medication you're taking, as long as your doses are stable. The total duration of your active involvement in the study will be for these 12 weeks of sessions plus the initial and final assessments.

Potential risks and benefits

Potential benefits of taking part in this study include improved balance and a reduced risk of falls, which could boost your confidence and make daily activities easier. You would also be contributing to important research that could help many other people with Parkinson's in the future. Potential risks are generally low, mainly related to exercise, such as muscle soreness or fatigue. The exercise game is designed to be safe, but just like any physical activity, there's a small chance of discomfort or a fall, though safety measures will be in place to minimise this. Your safety and well-being are a top priority, and you have the right to withdraw from the study at any time, for any reason, without it affecting your care.

Locations (1)

University of Leicester
Leicester, United Kingdom· Recruiting

Common questions

What is 'brain training' (neurofeedback)?

It's a technique that helps you learn to change your brain activity. In this study, while you play an exercise game, you'll get real-time feedback on your brainwaves, helping you 'train' your brain.

What is the exercise game like?

It's a virtual reality game where you travel down a road and dodge objects by shifting your body, or catch stars. It's designed to improve movement, balance, fitness, and coordination.

How long will the study last if I join?

You'll have an initial assessment, then attend exercise sessions three times a week for 12 weeks (about 36 sessions), followed by a final assessment.

Will I know which group I'm in?

No, this is a 'double-blind' study, meaning neither you nor the researchers analysing the data will know if you're getting the real brain training or the dummy feedback. This helps make the results more reliable.

What if I feel unwell during the study?

Your safety is important. If you feel unwell or unable to continue at any point, you can stop participating without it affecting your usual medical care.

How to find out more

Yasmin Godhania

RGOsponsor@leicester.ac.uk 0116 373 6039 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.