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Completed

NCT Number: NCT05385497

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

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UT Health San Antonio- Dept. of Physical Therapy

San Antonio, Texas, 78229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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.
  • 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.

Treatment and study plan

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

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.

Primary outcomes

  1. Gait speed

    Time frame: Baseline to 3 weeks

    10 Meter Walk Test for comfortable and fast gait speed (m/s).

  2. Spatiotemporal Parameters

    Time frame: Baseline to 3 weeks

    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.

  3. Cognition

    Time frame: Baseline to 3 weeks

    Parkinson's disease (PD)-cognitive rating scale

  4. Balance

    Time frame: Baseline to 3 weeks

    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.

  5. Corticomotor excitability

    Time frame: Baseline to 3 weeks

    Change in Corticomotor excitability as measured with transcranial magnetic stimulation (TMS).

Secondary outcomes

  1. Quality of Life Survey

    Time frame: Baseline to 3 weeks

    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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Collaborators

  • Texas Physical Therapy Association

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 23, 2022
Registry last updated
Oct 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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