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

Primary Purpose

Parkinson's Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aerobic Exercise
Virtual Reality
Sponsored by
The University of Texas Health Science Center at San Antonio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Parkinson's Disease focused on measuring Aerobic Exercise, Virtual Reality

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UT Health San Antonio- Dept. of Physical TherapyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

Individuals diagnosed with PD will participate in AE and VR.

Outcomes

Primary Outcome Measures

Gait speed
10 Meter Walk Test for comfortable and fast gait speed (m/s).
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.
Cognition
Parkinson's disease (PD)-cognitive rating scale
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.
Corticomotor excitability
Change in Corticomotor excitability as measured with transcranial magnetic stimulation (TMS).

Secondary Outcome Measures

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.

Full Information

First Posted
May 17, 2022
Last Updated
March 31, 2023
Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
Texas Physical Therapy Association
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1. Study Identification

Unique Protocol Identification Number
NCT05385497
Brief Title
Combining Aerobic Exercise and Virtual Reality for Cognitive-motor Rehabilitation in PD
Official Title
Combining Aerobic Exercise and Virtual Reality for Cognitive-motor Rehabilitation in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 7, 2022 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
Texas Physical Therapy Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Aerobic Exercise, Virtual Reality

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This study will utilize a single group, pre-post design
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Combined Aerobic Exercise (AE) and Virtual Reality (VR)-based program
Arm Type
Experimental
Arm Description
Individuals diagnosed with PD will participate in AE and VR.
Intervention Type
Other
Intervention Name(s)
Aerobic Exercise
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Virtual Reality
Intervention Description
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.
Primary Outcome Measure Information:
Title
Gait speed
Description
10 Meter Walk Test for comfortable and fast gait speed (m/s).
Time Frame
Baseline to 3 weeks
Title
Spatiotemporal Parameters
Description
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.
Time Frame
Baseline to 3 weeks
Title
Cognition
Description
Parkinson's disease (PD)-cognitive rating scale
Time Frame
Baseline to 3 weeks
Title
Balance
Description
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.
Time Frame
Baseline to 3 weeks
Title
Corticomotor excitability
Description
Change in Corticomotor excitability as measured with transcranial magnetic stimulation (TMS).
Time Frame
Baseline to 3 weeks
Secondary Outcome Measure Information:
Title
Quality of Life Survey
Description
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.
Time Frame
Baseline to 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 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.
Facility Information:
Facility Name
UT Health San Antonio- Dept. of Physical Therapy
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anjali Sivaramakrishnan, PT, PhD
Phone
210-567-8626
Email
sivaramakris@uthscsa.edu

12. IPD Sharing Statement

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

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