Parkinson Disease (PD)NCT03961282
CODY (Co-design for You): An Immersive Technology Tool for Experiencing and Assessing Home Alterations
A study testing Doorway Width Test and Door Frame Color Test in people with Parkinson Disease (PD), run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 92 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease (PD)
- What is being tested?
- Doorway Width Test and Door Frame Color Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2019to 30 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 92 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Shimberg Center for Housing Studies
Gainesville, Florida, 32603
About this study
Official title: CODY (Co-design for You): An Immersive Technology Tool for Experiencing and Assessing Home Alterations for Veterans With Movement Disabilities and Disorders
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.
Read the 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.
- Conditions
- Parkinson Disease (PD)
- Being tested
- Doorway Width Test, Door Frame Color Test
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doorway Width TestOther
Also called Test #1
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.
Door Frame Color TestOther
Also called Test #2
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).
| Study group | Role | What they receive |
|---|---|---|
| Parkinson Disease Group | Experimental | 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. Receives: Other: Doorway Width Test; Other: Door Frame Color Test |
| Healthy Participant Group | Experimental | 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. Receives: Other: Doorway Width Test; Other: Door Frame Color Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 (3 seconds)
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.
Measured: Day 1 (0.8 second)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study start25 May 2019
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson Disease (PD)Studies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ravi Srinivasan, PhD, Principal investigator, University of FloridaShabboo Valipoor, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03961282
- Sponsor's protocol ID
- IRB201802634
- Status last verified
- Jan 2020
- First submitted
- 21 May 2019
- Last updated
- 3 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CODY (Co-design for You): An Immersive Technology Tool for Experiencing and Assessing Home Alterations for Veterans With Movement Disabilities and Disorders
- ClinicalTrials.gov ID
- NCT03961282
- Acronym / sponsor ID
- IRB201802634
- Conditions
- Parkinson Disease (PD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 25 May 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 23 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Parkinson Disease Group | Experimental | Other: Doorway Width Test, Other: Door Frame Color TestEach 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. |
| Healthy Participant Group | Experimental | Other: Doorway Width Test, Other: Door Frame Color TestEach 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. |
Who may qualify
- Ages
- 40 to 92 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doorway Width TestAlso: Test #1The 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 | Healthy Participant Group, Parkinson Disease Group |
| Door Frame Color TestAlso: Test #2The 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 | Healthy Participant Group, Parkinson Disease Group |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2020.
- Individual participant dataSharing planned: No
Related trials for Parkinson Disease (PD)
Recruiting
Automated Language Analysis in Neurodegenerative Diseases: Application of Artificial Intelligence Models
Alzheimer's Disease (AD), Frontotemporal Dementia (FTD)
Recruiting
Investigating Basal Ganglia-Cortical Physiology During Sleep and Its Modulation by Adaptive Deep Brain Stimulation in Parkinson Disease
Parkinson's Disease (PD)
Active, not recruitingPhase 2
A Study to Evaluate Efficacy, Safety and Tolerability of Hydroxychloroquine in Subjects With Parkinson's Disease
Parkinson&Amp;#39;s Disease
RecruitingPhase 2
A Phase 2 Study and Open-Label Extension of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease
Parkinson Disease, Parkinson
RecruitingPhase 2/3
A Study of Buntanetap in Participants With PD
Parkinson's Disease (PD), Deep Brain Stimulation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ravi Srinivasan, PhD principal investigator
University of Florida
Shabboo Valipoor, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doorway Width Test and Door Frame Color Test in people with Parkinson Disease (PD), run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait time (time frame: Day 1 (3 seconds)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2020.