Elisa Arch’s Return to Campus Request Summary

SUBMISSION DATE: 02/09/2021
SENT TO: John Jeka 02/09/2021
Submission Number 1391
Opening Phases Phase 3
Name Elisa Arch
Academic Classification Assistant Professor Tenure-Track
PI Email schranke@udel.edu
Emergency Contact / Phone Number 3014618166
College College of Health Sciences
Department KINESIOLOGY and APPL PHYSIOLOGY
Lab/Facility STAR HEALTH SCIENCE COMPLEX
Limited Face-to-Face Human Subject Interaction This research includes face-to-face human subject interaction. This request is for to resume research studies in my lab involving studying how healthy adult human subjects walk with and adapt to wearing orthotic devices. Research activities for this study will take place in the Orthotics & Prosthetics Lab for Enhanced Mobility (O.P.En. Mobility Lab; Rm 119 STAR HSC), which is an 895 square foot space that therefore has the capacity to hold 7 personnel at a time.

Please note, all research procedures/tests that will be conducted as part of this study have already been approved to restart as part of other studies in Dr. Arch’s lab, just with a different human subjects population. In other words, there are no novel activities that will be conducted as part of this study that have not previously been approved to resume.

Participants in this study are medically healthy individuals. This study consists of a baseline visit, and one or more orthosis fitting/use visits. Each visit takes a maximum of 2 hours to complete. At each visit, motion analysis data will be collected while the participant walks, either with or without wearing the orthotic device. There will at most be 4 individuals (1 participant and 3 research team members) in the laboratory at the same time.

For the majority of the activities, the participant and research team members will all remain more than 6 feet part. Close contact will occur in the following scenarios:
1. Participant setup for the motion analysis – markers and safety harness will be placed on the participant’s skin and anthropometric measurements (height, weight, limb/segment lengths) taken. This process involves palpating anatomical landmarks on the participant and measuring various aspects of the participant’s limbs. We will conduct this setup step as quickly as possible, although this process typically takes 20-30minutes. At the end of the data collection, all markers will be removed from the participant, which takes just a few minutes. This process will be performed by the lead researcher. This process is performed at each data collection in this study.
2. Orthosis Fitting (10 minutes or less) – In the visits involving use of the orthotic device, the participant will put on the orthotic device, and its fit (padding, straps, etc.) will be adjusted as necessary. The lead researcher will assist the participant with putting on the orthosis and adjust padding and strapping, as necessary. This process takes less than 10 minutes.

All equipment and reusable supplies will be cleaned with approved disinfectant after every use. All disposable supplies will be properly discarded after use. All contact points (e.g. desks, computer mice, keyboards, power switches, cabinet doors/handles, light switches, research materials) will be disinfected at the beginning and end of every lab session.

We do not consider any of the activities that will be performed as part of this study to be aerobically demanding and thus the activities will have limited generation of aerosols as participants will be wearing a mask. Researchers who will be in close contact with the participant, as described above, will wear a surgical mask and a face shield. Researchers present in the room but not in extended (>10 minutes) contact with the participant will wear a surgical face mask. In all cases, a researcher may wear a cloth mask over the surgical mask so the latter can be preserved for up to 10 days. Researchers will wear disposable gloves when touching the participant.

Physical Distancing and Density Requirements When close contact is not required, research team members will maintain at least 6 feet distance between each other and the research participant. Researchers who will be in close contact with the participant for more than 10 min will wear a surgical mask and a face shield. Researchers present in the room but not in extended (> 10 min) contact with the participant will wear a surgical face mask. In all cases, a researcher may wear a cloth mask over the surgical mask so the latter can be preserved for up to 10 days. Researchers will wear disposable gloves when touching the participant.

The Orthotics & Prosthetics for Enhanced Mobility Laboratory (room 119 STAR HSC) is 895 square feet and so has the capacity for 7 individuals at a time. All activities will remain well under the max personnel capacity. Electronic calendars are used for scheduling the lab spaces. We will post a sign on the lab door whenever the lab is in use to ensure that distancing and density requirements are maintained.

Additional team members that will need access

Jacob Skigen

TITLE: Graduate Student, EMAIL: jtskigen@udel.edu, CONTACT: , LAB/FACILITY: STAR HEALTH SCIENCE COMPLEX, RM# RM 119

Sarah Garcon

TITLE: Graduate Student, EMAIL: sgarcon@udel.edu, CONTACT: , LAB/FACILITY: STAR HEALTH SCIENCE COMPLEX, RM# RM 119

Keira Morgan

TITLE: Undergraduate, EMAIL: keimorg@udel.edu, CONTACT: , LAB/FACILITY: STAR HEALTH SCIENCE COMPLEX, RM# RM 119

Department Chair John Jeka
Department Chair Email jjeka@udel.edu
Signature Elisa Arch