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

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ClinicalTrials.gov Identifier: NCT03961282
Recruitment Status : Recruiting
First Posted : May 23, 2019
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
University of Florida

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.

Condition or disease Intervention/treatment Phase
Parkinson Disease (PD) Other: Doorway Width Test Other: Door Frame Color Test Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Supportive Care
Official Title: CODY (Co-design for You): An Immersive Technology Tool for Experiencing and Assessing Home Alterations for Veterans With Movement Disabilities and Disorders
Actual Study Start Date : May 25, 2019
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Parkinson Disease Group
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.
Other: Doorway Width Test
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.
Other Name: Test #1

Other: Door Frame Color Test
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).
Other Name: Test #2

Experimental: Healthy Participant Group
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.
Other: Doorway Width Test
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.
Other Name: Test #1

Other: Door Frame Color Test
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).
Other Name: Test #2




Primary Outcome Measures :
  1. Gait time [ Time Frame: Day 1 (3 seconds) ]
    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.

  2. Step time [ Time Frame: Day 1 (0.8 second) ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 92 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03961282


Contacts
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Contact: Sherry Ahrentzen, PhD 352-273-1229 ahrentzen@ufl.edu

Locations
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United States, Florida
Shimberg Center for Housing Studies Recruiting
Gainesville, Florida, United States, 32603
Contact: Sherry Ahrentzen, PhD    352-273-1229    ahrentzen@ufl.edu   
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Ravi Srinivasan, PhD University of Florida
Principal Investigator: Shabboo Valipoor, PhD University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03961282     History of Changes
Other Study ID Numbers: IRB201802634
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases