Parkinson's DiseaseNCT05385497
Combining Aerobic Exercise and Virtual Reality for Cognitive-motor Rehabilitation in PD
A study testing Aerobic Exercise and Virtual Reality in people with Parkinson's Disease, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Aerobic Exercise and Virtual Reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2022to 15 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UT Health San Antonio- Dept. of Physical Therapy
San Antonio, Texas, 78229
About this study
Official title: Combining Aerobic Exercise and Virtual Reality for Cognitive-motor Rehabilitation in Parkinson's Disease
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.
Read the 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.
- Conditions
- Parkinson's Disease
- Being tested
- Aerobic Exercise, Virtual Reality
- Keywords
- Aerobic Exercise, Virtual Reality
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseOther
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 RealityDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Combined Aerobic Exercise (AE) and Virtual Reality (VR)-based program | Experimental | Individuals diagnosed with PD will participate in AE and VR. Receives: Other: Aerobic Exercise; Device: Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait speed
10 Meter Walk Test for comfortable and fast gait speed (m/s).
Measured: 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.
Measured: Baseline to 3 weeks
Cognition
Parkinson's disease (PD)-cognitive rating scale
Measured: 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.
Measured: Baseline to 3 weeks
Corticomotor excitability
Change in Corticomotor excitability as measured with transcranial magnetic stimulation (TMS).
Measured: Baseline to 3 weeks
Secondary outcomes (1)
Quality of Life Survey
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.
Measured: Baseline to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start7 Nov 2022
- Primary completion15 Jul 2023
- Study completion15 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study will utilize a single group, pre-post design
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Texas Physical Therapy Association
- Responsible party
- Sponsor
- Investigators
- Anjali Sivaramakrishnan, PT, PhD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05385497
- Sponsor's protocol ID
- HSC20220064H
- Status last verified
- Oct 2025
- First submitted
- 17 May 2022
- Last updated
- 9 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Aerobic Exercise and Virtual Reality for Cognitive-motor Rehabilitation in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05385497
- Acronym / sponsor ID
- HSC20220064H
- Conditions
- Parkinson's Disease
- Keywords
- Aerobic Exercise, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- Texas Physical Therapy Association
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 15 Jul 2023 (actual)
- First posted
- 23 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study will utilize a single group, pre-post design
| Arm | Type | Receives |
|---|---|---|
| Combined Aerobic Exercise (AE) and Virtual Reality (VR)-based program | Experimental | Other: Aerobic Exercise, Device: Virtual RealityIndividuals diagnosed with PD will participate in AE and VR. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic ExerciseParticipants 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 | Other | Combined Aerobic Exercise (AE) and Virtual Reality (VR)-based program |
| Virtual RealityParticipants 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. | Device | Combined Aerobic Exercise (AE) and Virtual Reality (VR)-based program |
Primary outcome
Gait speed
Time frame: Baseline to 3 weeks
10 Meter Walk Test for comfortable and fast gait speed (m/s).
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.
Cognition
Time frame: Baseline to 3 weeks
Parkinson's disease (PD)-cognitive rating scale
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.
Corticomotor excitability
Time frame: Baseline to 3 weeks
Change in Corticomotor excitability as measured with transcranial magnetic stimulation (TMS).
1 secondary outcome
Quality of Life Survey
Time frame: Baseline to 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anjali Sivaramakrishnan, PT, PhD principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise and Virtual Reality in people with Parkinson's Disease, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait speed (time frame: Baseline to 3 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2025.