Brain Training to Improve Balance in Parkinson's Disease
ConditionParkinson Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of Leicester
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Exergame+Neurofeedback
BehavioralElectroencephalography (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.
Exergame [alone]
BehavioralThe 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Exergame & NeurofeedbackActive comparator 1 intervention
Group B: Exergame & SHAM FeedbackSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Balance Scores
Changes in balance scores using The Limits of stability (LOS) test. This dynamic balance score is measured using a commercially available system (Bertec CDP/IVRTM (Interacoustics)).The participants will be asked to stand barefoot on the centre of the force platform, and will be support by a secure harness throughout to prevent falls. The assessment requires each participant to move their centre of pressure (COP) towards an intended target in the following order: forward, forward right, right, backward right, backward, backward left, left and forward left. Movement velocity (degrees per second), maximal excursion (greatest distance \[cm\] achieved towards the intended target/maximal distance of target \[cm\]) and directional control (\[the amount of intended movement - amount of extraneous movement)/amount of intended movement\] × 100) will be measured, representing the maximum distance an individual can intentionally sway without losing balance or needing to take a step.
Time frame
12 weeksSecondary outcomes
1
Sensory Organisation Scores
Changes in the Sensory Organisation test scores, calculated by an interval scale, with 100 indicating no sway and 0 indicating an uncompleted trial. This task comprises six different sensory conditions in quiet stance and measures the COP path in centimetres. The test progressively becomes harder by either distracting or removing visual and/or proprioceptive feedback. During sway-referenced conditions, erroneous sensory information is presented to the participant while the force platform measures the participant's ability to compensate by using other senses to maintain balance. The following sensory conditions will be used: * Condition 1: Eyes open and fixed support * Condition 2: Eyes closed and fixed support * Condition 3: Eyes open sway-referenced and support sway-referenced * Condition 4: Eyes open and support sway referenced * Condition 5: Eyes closed and support sway-referenced * Condition 6: Eyes open and sway-referenced with support sway-referenced
Time frame
12 weeks2
Daily Life Scores
Changes of activities in daily life. The investigators will use a validated questionnaire to asses functional improvements in activities associated with everyday living. Activities of Daily Living Questionnaire (ADLQ) - A questionnaire aimed for use with patients diagnosed with cognitive impairments, which assesses function in ADL tasks across 6 areas of life. A set of four descriptions of different competence levels; scores range from 0 to 3 where higher scores indicate greater impairment. A fifth response option, "don't know/has never done" is also available, and if this option is selected, the item is excluded from scoring.
Time frame
12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Leicester
Lead sponsor
University of Exeter
Collaborator
University of Nottingham
Collaborator
University of Plymouth
Collaborator
European Bioinformatics Institute
Collaborator
Source ClinicalTrials.gov