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

NCT ID: NCT05385497

Last Updated: 2025-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-07

Study Completion Date

2023-07-15

Brief Summary

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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

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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.

Conditions

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Parkinson's Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

PREVENTION

Blinding Strategy

NONE

Study Groups

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

Individuals diagnosed with PD will participate in AE and VR.

Group Type EXPERIMENTAL

Aerobic Exercise

Intervention Type 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 StepOneā„¢ recumbent stepper

Virtual Reality

Intervention Type 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.

Interventions

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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 StepOneā„¢ recumbent stepper

Intervention Type OTHER

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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Texas Physical Therapy Association

OTHER

Sponsor Role collaborator

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anjali Sivaramakrishnan, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at San Antonio

Locations

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UT Health San Antonio- Dept. of Physical Therapy

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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HSC20220064H

Identifier Type: -

Identifier Source: org_study_id

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