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NCT06133283 | RECRUITING | Parkinson Disease

Endurance Exercise & Virtual Reality for Optimizing Cortical Excitability and Neuroplasticity in PD
Sponsor:

The University of Texas Health Science Center at San Antonio

Brief Summary:

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).

Condition or disease

Parkinson Disease

Intervention/treatment

High intensity endurance exercise

Stretching exercise

Virtual reality (VR)-based gaming

Phase

NA

Detailed Description:

This study will enroll individuals diagnosed with Parkinson's disease who will be randomly assigned to 2 groups: 1) high intensity endurance exercise and virtual reality (experimental) or 2) stretching and virtual reality (control) for eight weeks (three sessions, thrice weekly). Outcomes will include balance and gait measures, blood-based biomarkers, neuroplasticity measures (assessed by transcranial magnetic stimulation), spinal reflex excitability (measured by H reflex) and quality of life.

Study Type : INTERVENTIONAL
Estimated Enrollment : 16 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : High Intensity Endurance Exercise as a Primer to Virtual Reality for Optimizing Cortical Excitability and Neuroplasticity in Parkinson's Disease (PD)
Actual Study Start Date : 2024-02-09
Estimated Primary Completion Date : 2026-12-31
Estimated Study Completion Date : 2026-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 85 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Diagnosis of idiopathic PD (ages 18 -85) in Hoehn and Yahr stages 2 - 3.
  • 2. Subjects need to demonstrate a score of equal to or greater than 23 on the Mini Mental State Examination.
  • 3. Subjects who have a score of ≤21.5 on the Mini Balance Evaluations Systems Test (miniBESTest).
Exclusion Criteria
  • 1. Subjects with a history of other neurological diseases (i.e., stroke, multiple sclerosis).
  • 2. Subjects with a history of severe cardiopulmonary disease, uncontrolled hypertension, orthostatic hypotension, uncontrolled diabetes, severe osteoporosis, severe arthritis affecting their lower extremity joints.
  • 3. Subjects with a history of PD-specific surgical procedures such as deep brain stimulation etc.
  • 4. Subjects with a history of head injury.
  • 5. Subjects with a history of seizures or epilepsy.
  • 6. Subjects who are currently pregnant.
  • 7. Individuals who use of medications that could alter corticomotor excitability or increase risk of seizure.
  • 8. Individuals with skull abnormalities, fractures or unexplained, recurring headaches.
Endurance Exercise & Virtual Reality for Optimizing Cortical Excitability and Neuroplasticity in PD

Location Details

NCT06133283

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Texas

UT Health San Antonio- Dept. of Physical Therapy

Saint Anthony, Texas, United States, 78229