Real-time Location System Feasibility Study

Real-time Location System Feasibility Study Part 2

The proposed study will investigate the feasibility of using the Wake Forest Real-time Location System (RTLS) in monitoring patient movement during their in-hospital postoperative recovery. The study will involve patients who have undergone surgery requiring inpatient admission to the surgical ward. Actual patient movement will be monitored during their postoperative recovery and compared with data recorded by the Wake Forest location system.

In this small pilot study, a subgroup of participants will be randomized to two cohorts, continuous walking and interval walking. Tolerability of the varied walking intensity will be measured.

Study Overview

• Status: Completed
• Conditions: Surgery; Mobility
• Intervention / Treatment: Behavioral: Ambulation

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Comprehensive Cancer Center of Wake Forest University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria

• Male or female patients between the ages of 18 and 90.
• Admitted to the Surgical Ward.
• Recovering from surgery.
• Ability to understand and the willingness to sign an Institutional Review Board-approved informed consent document.
• Ability to understand and complete the study survey instruments in English.

Exclusion criteria

• Non-surgical patient.
• Emergency surgical procedure.
• Anticipated discharge less than 24 hour.
• Unable to ambulate or ambulation not permitted by treating provider.
• Unable to understand and complete the study survey instruments in English.
• Post-operative complications that in the opinion of the study investigator would impair the ability of the patient to adhere to the study procedures.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Continuous Ambulation; The total distance will be 40 meters. Study team members will walk, support, and coach the subject to walk as slow as he/she wants	Behavioral: Ambulation; Variation in ambulatory intensity.
Active Comparator: Interval Ambulation; The subject will walk a total distance of 40 meters. This distance will be divided into four intervals of 10 meters to equal the same measured distance as the continuous group. The subject will receive two minutes of rest between each interval and will be supported and coached to walk as fast as they can.	Behavioral: Ambulation; Variation in ambulatory intensity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characterize Number of Participants Who Tolerate Continuous vs Interval 40m Walk.	Characterize number of participants who tolerate continuous vs interval 40m walk by evaluation of adverse events and change in vital signs.	1 day

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2019
• Primary Completion (Actual): June 19, 2019
• Study Completion (Actual): August 19, 2022

Study Registration Dates

• First Submitted: June 12, 2019
• First Submitted That Met QC Criteria: June 14, 2019
• First Posted (Actual): June 17, 2019

Study Record Updates

• Last Update Posted (Estimated): February 22, 2024
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: IRB00039439

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No