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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05385497
Enrollment
10
Registered
2022-05-23
Start date
2022-11-07
Completion date
2023-07-15
Last updated
2025-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Keywords

Aerobic Exercise, Virtual Reality

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.

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.

Interventions

OTHERAerobic 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

DEVICEVirtual 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.

Sponsors

Texas Physical Therapy Association
CollaboratorOTHER
The University of Texas Health Science Center at San Antonio
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Gait speedBaseline to 3 weeks10 Meter Walk Test for comfortable and fast gait speed (m/s).
Spatiotemporal ParametersBaseline to 3 weeksSpatiotemporal 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.
CognitionBaseline to 3 weeksParkinson's disease (PD)-cognitive rating scale
BalanceBaseline to 3 weeksBalance 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.
Corticomotor excitabilityBaseline to 3 weeksChange in Corticomotor excitability as measured with transcranial magnetic stimulation (TMS).

Secondary

MeasureTime frameDescription
Quality of Life SurveyBaseline to 3 weeksChange 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026