## Protocol Section
### Identification Module
**NCT ID:** NCT04003779

**Brief Title:** Reconfiguring the Patient Room to Increase Patient Stability

**Official Title:** Reconfiguring the Patient Room for a Fall Protection Strategy to Increase Patient Stability During Ambulation

#### Organization Study ID Info
**ID:** 00099410
#### Organization
**Class:** OTHER
**Full Name:** University of Utah
### Status Module
#### Completion Date
**Date:** 2024-09-29

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-11-08

**Type:** ACTUAL

**Last Update Submit Date:** 2023-11-07

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-09

**Type:** ESTIMATED

#### Start Date
**Date:** 2022-07-14

**Type:** ACTUAL

**Status Verified Date:** 2023-11

#### Study First Post Date
**Date:** 2019-07-01
**Type:** ACTUAL
**Study First Submit Date:** 2019-06-25
**Study First Submit QC Date:** 2019-06-28
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** The Center for Health Design

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Utah

#### Responsible Party

**Investigator Affiliation:** University of Utah

**Investigator Full Name:** Bob Wong

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Despite decades of research into patient falls, falls and the injuries incurred continue to be a serious threat to patient safety. Fall rates continue to be unacceptably high. The purpose of this project is to increase the safety of a hospital room for patient mobility, using innovative simulation strategies and patient-centric design.

**Detailed Description:** Despite decades of research into patient falls, falls and the injuries incurred continue to be a serious threat to patient safety. Fall rates continue to be unacceptably high. The purpose of this project is to increase the safety of a hospital room for patient mobility, using innovative simulation strategies and patient-centric design.

An innovative simulation environment will be built to enable rapid assessment of room layout and fixture positioning and patient stability. The results from multiple simulations will be used to fabricate a prototype room layout that will be tested by patients with Parkinson disease and reviewed and updated with input from other relevant stakeholders. A final room prototype will be built and tested. Results will be translated and shared with all stakeholders and disseminated for implementation.

### Conditions Module

**Conditions:**

- Elderly, Frail

- Accidental Falls

- Hospitals

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

**Intervention Model Description:** Using virtual reality and ergonomic measures, we will sequentially adjust features of the hospital room to determine the most stable gate in frail elderly patients.

##### Masking Info

**Masking:** NONE

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 25

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Single-arm. Ergonomically exploring patient stability moving around various configurations of a hospital room.

**Intervention Names:**

- Other: Room configuration

**Label:** Participant stability with various room configurations

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Participant stability with various room configurations

**Description:** Adjust distance, handrails, degrees of turn for participant

**Name:** Room configuration

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Increased balance

**Measure:** Gait: increased stability

**Time Frame:** 24 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Frail elderly, impaired gait

Exclusion Criteria:

* Use of walking aid

**Minimum Age:** 60 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** bob.wong@nurs.utah.edu

**Name:** Bob G Wong, PhD

**Phone:** 801-587-9666

**Role:** CONTACT

**Contact 2:**

**Email:** a.merryweather@utah.edu

**Name:** Andrew Merryweather, PhD

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Salt Lake City

**Contacts:**

***Contact 1:***

- **Email:** u0104136@utah.edu

- **Name:** Bo Foreman

- **Phone:** 801-581-3496

- **Role:** CONTACT

**Country:** United States

**Facility:** Dumke Health Professions Building

**State:** Utah

**Status:** RECRUITING

**Zip:** 84108

#### Overall Officials

**Official 1:**

**Affiliation:** University of Utah

**Name:** Bob G Wong, PhD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** University of Utah

**Name:** Andrew Merryweather, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
