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

Not Applicable

Recruiting

• Conditions: Parkinson's Disease
• Interventions: Other: Aerobic Exercise; Device: Virtual Reality

• Registration Number: NCT05385497
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

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 25 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 Timeline

• Study First Submitted: 2022-05-17
• Study First Submitted QC: 2022-05-17
• Study First Posted: 2022-05-23
• Study Start: 2022-11-07
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-18
• Primary Completion: 2026-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Combined Aerobic Exercise (AE) and Virtual Reality (VR)-based program	Aerobic Exercise	Individuals diagnosed with PD will participate in AE and VR.
Combined Aerobic Exercise (AE) and Virtual Reality (VR)-based program	Virtual Reality	Individuals diagnosed with PD will participate in AE and VR.

Primary Outcome Measures

Name	Time	Method
Spatiotemporal Parameters	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.
Balance	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.
Gait speed	Baseline to 3 weeks	10 Meter Walk Test for comfortable and fast gait speed (m/s).
Cognition	Baseline to 3 weeks	Parkinson's disease (PD)-cognitive rating scale
Corticomotor excitability	Baseline to 3 weeks	Change in Corticomotor excitability as measured with transcranial magnetic stimulation (TMS).

Secondary Outcome Measures

Name	Time	Method
Quality of Life Survey	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.

Trial Locations

Locations (1)

UT Health San Antonio- Dept. of Physical Therapy; 🇺🇸 San Antonio, Texas, United States