Condition or disease | Intervention/treatment | Phase |
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Parkinson Disease (PD) | Other: Doorway Width Test Other: Door Frame Color Test | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 39 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 |
Actual Primary Completion Date : | September 30, 2019 |
Actual Study Completion Date : | September 30, 2019 |
Arm | Intervention/treatment |
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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.
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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
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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
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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 |
Inclusion Criteria: Parkinson's Disease participants
Exclusion Criteria:
United States, Florida | |
Shimberg Center for Housing Studies | |
Gainesville, Florida, United States, 32603 |
Principal Investigator: | Ravi Srinivasan, PhD | University of Florida | |
Principal Investigator: | Shabboo Valipoor, PhD | University of Florida |
Tracking Information | |||||||
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First Submitted Date ICMJE | May 21, 2019 | ||||||
First Posted Date ICMJE | May 23, 2019 | ||||||
Last Update Posted Date | January 3, 2020 | ||||||
Actual Study Start Date ICMJE | May 25, 2019 | ||||||
Actual Primary Completion Date | September 30, 2019 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | CODY (Co-design for You): An Immersive Technology Tool for Experiencing and Assessing Home Alterations | ||||||
Official Title ICMJE | CODY (Co-design for You): An Immersive Technology Tool for Experiencing and Assessing Home Alterations for Veterans With Movement Disabilities and Disorders | ||||||
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. |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Not Applicable | ||||||
Study Design ICMJE | 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 |
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Condition ICMJE | Parkinson Disease (PD) | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
39 | ||||||
Original Estimated Enrollment ICMJE |
50 | ||||||
Actual Study Completion Date ICMJE | September 30, 2019 | ||||||
Actual Primary Completion Date | September 30, 2019 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE |
Inclusion Criteria: Parkinson's Disease participants
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 40 Years to 92 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03961282 | ||||||
Other Study ID Numbers ICMJE | IRB201802634 | ||||||
Has Data Monitoring Committee | Not Provided | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | University of Florida | ||||||
Study Sponsor ICMJE | University of Florida | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | University of Florida | ||||||
Verification Date | January 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |