NCT06133283 · The University of Texas Health Science Center at San Antonio
Endurance Exercise & Virtual Reality for Optimizing Cortical Excitability and Neuroplasticity in PD
What this study is about
This study aims to determine the effects of aerobic exercise as a primer to add-on virtual reality (VR)-based rehabilitation on balance, postural control and neuroplasticity (ability of brain to adapt in structure and function) in individuals with Parkinson's disease (PD).
View original scientific description
This study aims to determine the effects of aerobic exercise as a primer to add-on virtual reality (VR)-based rehabilitation on balance, postural control and neuroplasticity (ability of brain to adapt in structure and function) in individuals with Parkinson's disease (PD). This study will utilize two groups - one group will receive the exercise and VR, while the other group will receive stretching exercise and VR over eight weeks. The study team will administer outcomes at baseline, post-intervention (8 weeks) and follow-up (6 weeks after post-assessment).
Interventions
BEHAVIORAL
High intensity endurance exercise
High intensity interval exercise on a recumbent stepper for 30 minutes, 3 days per week.
BEHAVIORAL
Stretching exercise
Stretches of face, neck, upper extremity, trunk and lower extremity muscles including whole body stretches for 30 minutes, 3 days per week.
BEHAVIORAL
Virtual reality (VR)-based gaming
VR games will involve games that challenge balance such as reaching different targets during activities such as sit to stand, dodging obstacles etc. Participants will play approximately 6 games for 30 minutes, 3 days a week.
Primary outcome measures
Balance
Time frame: Baseline, post (8 week), follow-up (14 weeks)
Balance will be tested with the Mini Balance Evaluation Systems Test(miniBESTest), involving 14 different tasks including the timed up and go test to assess static and dynamic balance. Scores range from 0 to 28 with higher scores suggesting better balance.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Diagnosis of idiopathic PD (ages 18 -85) in Hoehn and Yahr stages 2 - 3.
- Subjects need to demonstrate a score of equal to or greater than 23 on the Mini Mental State Examination.
- Subjects who have a score of ≤21.5 on the Mini Balance Evaluations Systems Test (miniBESTest).
Exclusion criteria
- Subjects with a history of other neurological diseases (i.e., stroke, multiple sclerosis).
- Subjects with a history of severe cardiopulmonary disease, uncontrolled hypertension, orthostatic hypotension, uncontrolled diabetes, severe osteoporosis, severe arthritis affecting their lower extremity joints.
- Subjects with a history of PD-specific surgical procedures such as deep brain stimulation etc.
- Subjects with a history of head injury.
- Subjects with a history of seizures or epilepsy.
- Subjects who are currently pregnant.
- Individuals who use of medications that could alter corticomotor excitability or increase risk of seizure.
- Individuals with skull abnormalities, fractures or unexplained, recurring headaches.
Where
- San Antonio, Texas
Collaborators
National Center for Advancing Translational Sciences (NCATS)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 31, 2026 · Source of record for eligibility and locations