Combining Aerobic Exercise and Virtual Reality for Cognitive-motor Rehabilitation in PD

Combining Aerobic Exercise and Virtual Reality for Cognitive-motor Rehabilitation in Parkinson's Disease

This project will provide preliminary data on the feasibility and effects of exercise and VR on motor behavior and neuroplasticity in PD. Results from this work will provide insight into whether combination interventions utilizing AE and VR have parallel effects on cognition, gait, and neuroplasticity in PD.

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease
• Intervention / Treatment: Other: Aerobic Exercise; Device: Virtual Reality

Detailed Description

In this pilot proof-of-concept study, the study team will recruit 10 individuals with Parkinson's disease who will perform aerobic exercise (AE) followed by virtual reality (VR). The study team will measure the effects of the intervention on dual task performance, clinical measures of gait, cognition, TMS measures and questionnaires pertaining to quality of life.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • UT Health San Antonio- Dept. of Physical Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Diagnosis of idiopathic PD (ages 18 - 85) in Hoehn and Yahr stages 1 - 3.
2. Subjects need to demonstrate a score of equal to or greater than 23 on the Mini Mental State Examination.

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.
3. Subjects with a history of PD-specific surgical procedure 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. Subjects who use of medications that could alter corticomotor excitability or increase risk of seizure
8. Subjects with skull abnormalities, fractures, unexplained, recurring headaches.
9. Subjects who have cognitive or communication impairment that would affect participation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Combined Aerobic Exercise (AE) and Virtual Reality (VR)-based program; Individuals diagnosed with PD will participate in AE and VR.

Other: Aerobic Exercise; Participants will perform a 30-minute exercise protocol (5 minutes warm-up and cool-down each and 20 minutes moderate intensity exercise) on a StepOne™ recumbent stepper; Device: Virtual Reality; Participants will interact with the virtual environment and view the gaming environment on a flat-screen TV placed in front of them at a suitable distance. The participants will play four games (50 repetitions/game divided into three blocks with 1-2 minutes rest between blocks), with the order of the games randomized in every session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait speed	10 Meter Walk Test for comfortable and fast gait speed (m/s).	Baseline to 3 weeks
Spatiotemporal Parameters	Spatiotemporal measures of gait will be acquired with a gait mat during single and dual task conditions. Participants will perform 2 trials each at their self-selected speed for the single task and dual task conditions for the the gait tests.	Baseline to 3 weeks
Cognition	Parkinson's disease (PD)-cognitive rating scale	Baseline to 3 weeks
Balance	Balance will be tested with the Mini-BESTest (Balance Evaluation Systems Test), involving 14 different tasks to assess static and dynamic balance. The Mini-BESTest is a clinical test for the construct of dynamic balance. It consists of 14 items, divided into four subcomponents: anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait. Items are scored from 0 (unable or requiring help) to 2 (normal) on an ordinal scale, with the maximal total score of 28 points. A higher score indicates better balance.	Baseline to 3 weeks
Corticomotor excitability	Change in Corticomotor excitability as measured with transcranial magnetic stimulation (TMS).	Baseline to 3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life Survey	Change in QoL as assessed by PDQ-8, a self-reported Parkinson's Disease Questionnaire using 8 questions with the answers: Never, occasionally, sometimes, often or always (or cannot do at all). Scores range from 0-32 with a higher score indicating worse quality of life.	Baseline to 3 weeks

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborators: Texas Physical Therapy Association
• Investigators: Principal Investigator: Anjali Sivaramakrishnan, PT, PhD, The University of Texas Health Science Center at San Antonio

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2022
• Primary Completion (Actual): July 15, 2023
• Study Completion (Actual): July 15, 2023

Study Registration Dates

• First Submitted: May 17, 2022
• First Submitted That Met QC Criteria: May 17, 2022
• First Posted (Actual): May 23, 2022

Study Record Updates

• Last Update Posted (Estimated): October 9, 2025
• Last Update Submitted That Met QC Criteria: October 7, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Virtual Reality; Aerobic Exercise
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: HSC20220064H

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No