Qualitative & Quantitative Comparison of Hydrostatic vs Vacuum Casting Methods in Trans-Tibial Amputees

Not Applicable

Completed

• Conditions: Hydrostatic Vacuum Casting
• Interventions: Other: vacuum casting; Other: hydrostatic casting

• Registration Number: NCT03891017
• Lead Sponsor: Loma Linda University

Brief Summary

The purpose of this graduate research study is to compare hydrostatic and vacuum casting techniques using patient mobility indicators, volume displacement, comfort, and overall satisfaction outcomes in trans-tibial amputees.

Detailed Description

Visit 1

* Informed Consent

* Subject will be casted using both the hydrostatic and vacuum system techniques

Visit 2 (7-10 days after Visit 1)

* One of two sockets will be randomly assigned and fitted/aligned by investigators

* Subject will be asked to perform a Timed Up and Go Test followed by a Six-Minute Walk Test

* Subject will fill out a comfort questionnaire for the prosthesis worn

Visit 3 (7 to 10 days after Visit 2)

• Subject will be asked to do the same testing as you performed in Visit 2

Study Timeline

• Study First Submitted: 2019-03-18
• Study First Submitted QC: 2019-03-25
• Study First Posted: 2019-03-26
• Study Start: 2019-04-01
• Status Verified: 2019-07
• Primary Completion: 2019-07-01
• Study Completion: 2019-07-01
• Last Update Submitted: 2019-07-11
• Last Update Posted: 2019-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
vacuum casting	vacuum casting	Vacuum casting will be performed using the Ottobock vacuum casting system. For our vacuum casting procedures, we will be following the protocols outlined in the Harmony Fabrication Quick Guide
hydrostatic casting	hydrostatic casting	For the aqua casting system, we will be using an in-house manufactured device. This device will be created following guidelines from the PCAST Technical Manual

Primary Outcome Measures

Name	Time	Method
Six-Minute Walk Test	between 7-10- days after study enrollment	Participants will walk in a 100-ft hallway on a flat, hard surface in a period of 6 minutes.

Secondary Outcome Measures

Name	Time	Method
Six-Minute Walk Test	between 14-20 days after study enrollment	Participants will walk in a 100-ft hallway on a flat, hard surface in a period of 6 minutes.
Volume Calculation	between 14-20 days after study enrollment	The Ohio Willow Wood Omega Tracer 3-dimensional image capture device and associated Omega shape capture software will be used to determine the volumes of each socket type, comparing the vacuum and aqua casting volume metrics. The scanning variables of width, depth, and length will determine the total displacement of each socket type. It has been determined that laser scanning is a valid and reliable method for accurately measuring volume fluctuations between casting methods.

Trial Locations

Locations (1)

Loma Linda Universtiy; 🇺🇸 Loma Linda, California, United States