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CODY (Co-design for You): An Immersive Technology Tool for Experiencing and Assessing Home Alterations

Primary Purpose

Parkinson Disease (PD)

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Doorway Width Test
Door Frame Color Test
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Parkinson Disease (PD)

Eligibility Criteria

40 Years - 92 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Parkinson's Disease participants

  • Patients with a mild-to-moderate diagnosis of PD, evaluated using the Unified Parkinson's Disease Rating Scale (UPDRS) and the Modified Hoehn and Yahr stages I-III, by a fellowship trained neurologist, arriving at the diagnosis by applying strict UK Brain Bank criteria
  • Disease duration is less than 5 years
  • With phone area code of 352; 904
  • Currently on their medications Inclusion Criteria: Healthy participants
  • Individuals who indicated they would like to be contacted for future research opportunities.
  • Age-matched (+ or - 5 years) healthy participants without PD
  • No history of neurological or orthopedic problems that could impair walking function or upper extremity mobility

Exclusion Criteria:

  • Individuals with atypical features of PD, peripheral neuropathy, vestibular dysfunction, and medications affecting balance or alertness/ attention
  • Individuals with the presence of active unstable medical, diabetes, or any orthopedic conditions
  • Individuals who have previously undergone any brain surgeries
  • Individuals who take any anti-psychotic medications
  • Individuals with dementia as reflected by performance on the Mini-Mental State Examination (MMSE) (score < 24)
  • Individuals with elevated scores on the Beck Depression Inventory-II (I.E., ≥20), the recommended cut-off for depressive symptoms in PD by the task force for the Movement Disorders Society or history of severe pre-existing psychiatric difficulties (i.e., schizophrenia)

Sites / Locations

  • Shimberg Center for Housing Studies

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Parkinson Disease Group

Healthy Participant Group

Arm Description

Each participant is randomized into 3 types of door alterations: Standard (conforms to conventional residential building practices); Enhanced (conforms to Americans with Disabilities Act or ADA residential building practices or recommendations); and Co-design. Then each participant performs Test #1: Doorway Width and Test #2: Door Frame Color.

Each participant is randomized into 3 types of door alterations: Standard (conforms to conventional residential building practices); Enhanced (conforms to Americans with Disabilities Act or ADA residential building practices or recommendations); and Co-design. Then each participant performs Test #1: Doorway Width and Test #2: Door Frame Color.

Outcomes

Primary Outcome Measures

Gait time
Participant will be instructed to walk on a 8' 6" long gait mat and pass through the doorway seen on the headset display. The middle portion of the gait mat with a length of 4' 3" is pressure sensitive and transmits gait time data to the software installed in the encrypted desktop. Gait time is the time between the first heel strike and the last toe off on the mat during the walk is measured as gait time.
Step time
Participant will be instructed to walk on a 8' 6" long gait mat and pass through the doorway seen on the headset display. The middle portion of the gait mat with a length of 4' 3" is pressure sensitive and transmits step time data to the software installed in the encrypted desktop. Step time is the time to complete one full gait cycle.

Secondary Outcome Measures

Full Information

First Posted
May 21, 2019
Last Updated
January 2, 2020
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT03961282
Brief Title
CODY (Co-design for You): An Immersive Technology Tool for Experiencing and Assessing Home Alterations
Official Title
CODY (Co-design for You): An Immersive Technology Tool for Experiencing and Assessing Home Alterations for Veterans With Movement Disabilities and Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
May 25, 2019 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
September 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
CODY (co-design for you) is a Virtual Reality (VR) tool and Application Programming Interface (API) which uses an immersive, interactive environment for using, experiencing and co-designing home alterations. The aim of this research is to assess the efficacy of using CODY to aid and enhance the ability of adults with Parkinson's disease (PD) to experience and choose appropriate home modifications.
Detailed Description
Accessible housing is a widespread need in this country. This is particularly true among those persons with mobility impairments and movement disorders. While design and construction guidebooks exist for modifying homes for people with disabilities, there are also many documented instances where a standard, "by-the-book" alteration or assistive technology did not support the need or condition of the particular individual it was intended for. Just as occupational therapists recognize that a critical component of successful rehabilitation assistance is a person-centered plan that facilitates individualized solutions, likewise diverse design (or home alterations/modification, referred here as HM) approaches which approximate a person-centered plan also provide a more effective fit for persons with disabilities. A "one-size-fits-all" approach is not comprehensive for the diverse disability community. This research entails the design and development of CODY (co-design for you), a Virtual Reality (VR) tool and Application Programming Interface (API), which uses an immersive, interactive environment for using, experiencing and co-designing home alterations. The 'co-design' nature of CODY denotes that persons with movement disorders, such as Parkinson's disease can: virtually interact with and experience a home alteration/modification (HM) in a virtual, simulated environment; have multiple variations of a HM that the user can choose from; and is able to assess and manipulate the HM for appropriateness to one's need and circumstances before actually installing devices or making modifications to one's own home. As such, CODY is a new assistive technology that aids and enhances the ability of individuals with disabilities to live in adapted homes that supports their needs. This study focuses on movement disorders faced by persons with Parkinson's disease (PD) to demonstrate how effective CODY may be for those with major movement challenges, characterized by tremor, bradykinesia, postural instability, and freezing of gait (FoG). Collectively, these symptoms increase fall risk, fear of falling and impact the quality of life when compared to other age-matched non-PD adults. While clinical observations suggest that attributes of the physical interior environment may make daily activities easier or harder for persons with PD, few studies have actually examined the impact of specific changes in interior design on an individual's performance. One research study revealed that FoG, one of the major contributors to falls, was induced by doorways. Another study similarly revealed a significant increase in doorway-provoked FoG indicators by decreasing doorway width. The aims of this research are: (1) To develop the Virtual Reality-based CODY tool and corresponding API; and (2) To assess the efficacy of using CODY to aid and enhance the ability of persons with PD to experience and choose appropriate home modifications. The underlying purpose of CODY is to provide opportunities for the growing population of persons with movement disabilities and disorders to actively engage in decisions affecting their living environment. Although VR games have been used for rehabilitation and therapy purposes, no research studies exist that demonstrate the use or effectiveness of integrated VT simulations in allowing persons with disabilities to interactively design residential alterations. The study team's expectation is that CODY will not only be successful in this short-term pilot study, but will lead to further refinement, development and, potentially, a commercial product. The investigators envision CODY's integrated, immersive, and interactive simulation will be used by neurologists, rehabilitation specialists, and occupational therapists for working with consumers to assess and determine optimal home modifications for those with ambulatory and other movement impairments.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease (PD)

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
There are 3 types of door alterations in a simulated residential setting being tested: Standard (conforms to conventional residential building practices); Enhanced (conforms to Americans with Disabilities Act or ADA residential building practices or recommendations); and Co-design.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Parkinson Disease Group
Arm Type
Experimental
Arm Description
Each participant is randomized into 3 types of door alterations: Standard (conforms to conventional residential building practices); Enhanced (conforms to Americans with Disabilities Act or ADA residential building practices or recommendations); and Co-design. Then each participant performs Test #1: Doorway Width and Test #2: Door Frame Color.
Arm Title
Healthy Participant Group
Arm Type
Experimental
Arm Description
Each participant is randomized into 3 types of door alterations: Standard (conforms to conventional residential building practices); Enhanced (conforms to Americans with Disabilities Act or ADA residential building practices or recommendations); and Co-design. Then each participant performs Test #1: Doorway Width and Test #2: Door Frame Color.
Intervention Type
Other
Intervention Name(s)
Doorway Width Test
Other Intervention Name(s)
Test #1
Intervention Description
The first test consists of Doorway Width. Standard level is a doorway width of 30 inches; Enhanced is doorway width of 36 inches; Co-design allows the participant to adjust the width anywhere from 26 to 48 inches.
Intervention Type
Other
Intervention Name(s)
Door Frame Color Test
Other Intervention Name(s)
Test #2
Intervention Description
The second test consists of Door Frame Color. Standard level is same color (hue) as light-color wall; Enhanced level is same hue but of higher color intensity for contrast; Co-design allows the participant to adjust the color intensity range from lowest (same as wall) to highest intensity (stronger contrast than in Enhanced).
Primary Outcome Measure Information:
Title
Gait time
Description
Participant will be instructed to walk on a 8' 6" long gait mat and pass through the doorway seen on the headset display. The middle portion of the gait mat with a length of 4' 3" is pressure sensitive and transmits gait time data to the software installed in the encrypted desktop. Gait time is the time between the first heel strike and the last toe off on the mat during the walk is measured as gait time.
Time Frame
Day 1 (3 seconds)
Title
Step time
Description
Participant will be instructed to walk on a 8' 6" long gait mat and pass through the doorway seen on the headset display. The middle portion of the gait mat with a length of 4' 3" is pressure sensitive and transmits step time data to the software installed in the encrypted desktop. Step time is the time to complete one full gait cycle.
Time Frame
Day 1 (0.8 second)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
92 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Parkinson's Disease participants Patients with a mild-to-moderate diagnosis of PD, evaluated using the Unified Parkinson's Disease Rating Scale (UPDRS) and the Modified Hoehn and Yahr stages I-III, by a fellowship trained neurologist, arriving at the diagnosis by applying strict UK Brain Bank criteria Disease duration is less than 5 years With phone area code of 352; 904 Currently on their medications Inclusion Criteria: Healthy participants Individuals who indicated they would like to be contacted for future research opportunities. Age-matched (+ or - 5 years) healthy participants without PD No history of neurological or orthopedic problems that could impair walking function or upper extremity mobility Exclusion Criteria: Individuals with atypical features of PD, peripheral neuropathy, vestibular dysfunction, and medications affecting balance or alertness/ attention Individuals with the presence of active unstable medical, diabetes, or any orthopedic conditions Individuals who have previously undergone any brain surgeries Individuals who take any anti-psychotic medications Individuals with dementia as reflected by performance on the Mini-Mental State Examination (MMSE) (score < 24) Individuals with elevated scores on the Beck Depression Inventory-II (I.E., ≥20), the recommended cut-off for depressive symptoms in PD by the task force for the Movement Disorders Society or history of severe pre-existing psychiatric difficulties (i.e., schizophrenia)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ravi Srinivasan, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shabboo Valipoor, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shimberg Center for Housing Studies
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32603
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

CODY (Co-design for You): An Immersive Technology Tool for Experiencing and Assessing Home Alterations

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