Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 85 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
This study will utilize a randomized controlled design
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
High intensity endurance exercise and virtual reality (experimental)
The exercise group will perform high intensity interval exercise and VR-based games 3 times a week for 8 weeks.
  • Behavioral: High intensity endurance exercise
    High intensity interval exercise on a recumbent stepper 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.
Other
Stretching and virtual reality (control)
The stretching group will perform stretching exercises and VR-based games 3 times a week for 8 weeks.
  • 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.

Recruiting Locations

UT Health San Antonio- Dept. of Physical Therapy
San Antonio, Texas 78229
Contact:
Anjali Sivaramakrishnan, PT, PhD
210-567-8626
sivaramakris@uthscsa.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center at San Antonio

Study Contact

Anjali Sivaramakrishnan, PhD
210-567-8626
sivaramakris@uthscsa.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.