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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05385497
• Other study ID #: HSC20220064H
• Status: Recruiting
• Phase: N/A
• Start date: November 7, 2022
• Est. completion date: April 2025

Study information

• Verified date: April 2024
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Other:
• 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 StepOne™ recumbent stepper

Device:
• 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.

Locations

Country	Name	City	State
United States	UT Health San Antonio- Dept. of Physical Therapy	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio	Texas Physical Therapy Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait speed	10 Meter Walk Test for comfortable and fast gait speed (m/s).	Baseline to 3 weeks
Primary	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.	Baseline to 3 weeks
Primary	Cognition	Parkinson's disease (PD)-cognitive rating scale	Baseline to 3 weeks
Primary	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.	Baseline to 3 weeks
Primary	Corticomotor excitability	Change in Corticomotor excitability as measured with transcranial magnetic stimulation (TMS).	Baseline to 3 weeks
Secondary	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.	Baseline to 3 weeks