Brain Training to Improve Balance in Parkinson's Disease (NCT05986643) | Clinical Trial Compass
RecruitingNot Applicable
Brain Training to Improve Balance in Parkinson's Disease
United Kingdom100 participantsStarted 2023-08-04
Plain-language summary
People living with Parkinson's (PwP) rank balance problems amongst the most disabling symptom. Over time, balance function continues to decline and PwP go on to fall, affecting between 45-68% of PwP. Falling directly impacts upon the individuals' quality of life (QoL), as it prevents patients from doing everyday activities, and places PwP at greater risk of other medical problems, such as fractures.
New treatments are urgently needed to improve balance and reduce falls in order to improve QoL for PwP. The aim of this project is to achieve these goals by using exercise to alter brain activity. Supporting our idea, are previous studies that show both exercise alone as well as changing brain activity at rest via visual feedback (similar to how breathing can be controlled to lower blood pressure), can be used to rehabilitate balance. Here researchers test the idea that better results can be achieved for PwP, if a specific exercise program is used as the feedback to change brain activity.
PwP will be assigned randomly into 2 groups, one receiving the exergaming physical therapy (PT) alone with a placebo feedback and, the second group will be required to change brain activity using exercise feedback to change brain activity.
Each intervention will be performed 3 times/week with each session lasting 1⁄2 an hour, for 12 consecutive weeks. Participants are expected to attend 5 sessions over each fortnight. Assessments of balance will be made before and after all three treatments. This will allow us to measure any improvements and compare the 2 different methods to see which one improves balance the most in PwP.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
*…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.