NCT03961282

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 23, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

May 25, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

January 3, 2020

Status Verified

January 1, 2020

Enrollment Period

4 months

First QC Date

May 21, 2019

Last Update Submit

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

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.

Other: Doorway Width TestOther: 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.

Other: Doorway Width TestOther: Door Frame Color Test

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.

Also known as: Test #1
Healthy Participant GroupParkinson Disease Group

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).

Also known as: Test #2
Healthy Participant GroupParkinson Disease Group

Eligibility Criteria

Age40 Years - 92 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Ravi Srinivasan, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR
  • Shabboo Valipoor, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
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

Locations