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

NCT05385497 | Completed

• 1 other identifier: HSC20220064H
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson's Disease

Keywords

Aerobic Exercise; Virtual Reality

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Quality of Life Survey

  Baseline to 3 weeks

Study Arms (1)

Combined Aerobic Exercise (AE) and Virtual Reality (VR)-based program

EXPERIMENTAL

Individuals diagnosed with PD will participate in AE and VR.

Other: Aerobic Exercise; Device: Virtual Reality

Interventions

Aerobic Exercise OTHER

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

Combined Aerobic Exercise (AE) and Virtual Reality (VR)-based program

Virtual Reality DEVICE

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.

Combined Aerobic Exercise (AE) and Virtual Reality (VR)-based program

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• Texas Physical Therapy Association: collaborator

Study Sites (1)

UT Health San Antonio- Dept. of Physical Therapy

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Exercise

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)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Anjali Sivaramakrishnan, PT, PhD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study will utilize a single group, pre-post design

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: May 23, 2022
• Study Start: November 7, 2022
• Primary Completion: July 15, 2023
• Study Completion: July 15, 2023
• Last Updated: October 9, 2025

Record last verified: 2025-10

Locations

US (1)