Brain Training to Improve Balance in Parkinson's Disease

NCT05986643 | Recruiting DMC

• 2 other identifiers: 0903324686
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease

Keywords

Balance; Gait

Outcome Measures

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.

  12 weeks

Secondary Outcomes (2)

• Sensory Organisation Scores

  12 weeks

• Daily Life Scores

  12 weeks

Study Arms (2)

Exergame & Neurofeedback

ACTIVE COMPARATOR

Six 5 minutes sets of participants standing on a balance board within virtual environment playing the exergame and receiving real neurofeedback with 1 minute rest between each set.

Behavioral: Exergame+Neurofeedback

Exergame & SHAM Feedback

SHAM COMPARATOR

Six 5 minutes sets of participants standing on a balance board within virtual environment playing the exergame and receiving SHAM neurofeedback with 1 minute rest between each set.

Behavioral: Exergame [alone]

Interventions

Exergame+Neurofeedback BEHAVIORAL

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.

Exergame & Neurofeedback

Exergame [alone] BEHAVIORAL

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.

Also known as: Exergame

Exergame & SHAM Feedback

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Leicester: lead
• University of Exeter: collaborator
• University of Nottingham: collaborator
• University of Plymouth: collaborator
• European Bioinformatics Institute: collaborator

Study Sites (1)

University of Leicester

Leicester, LE1 7RH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Exergaming; Single Person

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors

Study Officials

• Qadeer Arshad

  University of Leicester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yasmin Godhania

CONTACT

0116 373 6039; RGOsponsor@leicester.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Random computer generation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: To maintain the gold standard approach of complete randomisation but we have tightened the inclusion criteria to stipulate both a history of falls and freezing of gait (FoG).

Study Record Dates

• First Submitted: April 19, 2023
• First Posted: August 14, 2023
• Study Start: August 4, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Before the trial commences
• Access Criteria: No criteria

Locations

GB (1)