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RECRUITINGINTERVENTIONAL

Brain Training to Improve Balance in Parkinson's Disease

Using Biofeedback During Exergaming to Attenuate Alpha Oscillations to Improve Postural Control in People Living With Parkinson's.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: 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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

BEHAVIORAL

Exergame+Neurofeedback

Electroencephalography (EEG) is a device that measures the electrical activity of the brain (brain waves). There are several frequencies of brain waves when we are awake; alpha (medium), beta (fast), and theta (slow). Alpha frequencies of brain activity are linked to maintaining balance, with more alpha activity being associated with poorer balance. EEG neurofeedback treatment involves placing electrodes on a person's head to monitor and change brain activity by giving cued audio or visual feedback. It has been used in PwP to show improvements in balance and walking. Other preliminary research in PwP has shown that exercise can also improve balance.

BEHAVIORAL

Exergame [alone]

The exergame, delivered in virtual reality, involves travelling down a road (to give optic flow) whilst dodging balls that move towards the participant by either shifting their body either to the left or right. They are also be instructed to stand still and catch stars that appear and these will be used to score points and are associated with a monetary reward, ensuring motivation. This group will receive SHAM feedback.

Locations (1)

University of Leicester
Leicester, United Kingdom