CODY (Co-design for You): An Immersive Technology Tool for Experiencing and Assessing Home Alterations
1 other identifier
interventional
39
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2019
CompletedFirst Posted
Study publicly available on registry
May 23, 2019
CompletedStudy Start
First participant enrolled
May 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2019
CompletedJanuary 3, 2020
January 1, 2020
4 months
May 21, 2019
January 2, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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.
Day 1 (0.8 second)
Study Arms (2)
Parkinson Disease Group
EXPERIMENTALEach 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
EXPERIMENTALEach 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.
Interventions
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.
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).
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shimberg Center for Housing Studies
Gainesville, Florida, 32603, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ravi Srinivasan, PhD
University of Florida
- PRINCIPAL INVESTIGATOR
Shabboo Valipoor, PhD
University of Florida
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2019
First Posted
May 23, 2019
Study Start
May 25, 2019
Primary Completion
September 30, 2019
Study Completion
September 30, 2019
Last Updated
January 3, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share