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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Exergame+Neurofeedback
- Exergame [alone]
Treatment groups
Sponsors and collaborators
University of Leicester
Lead sponsor
University of Exeter
Collaborator
University of Nottingham
Collaborator
University of Plymouth
Collaborator
European Bioinformatics Institute
Collaborator