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

Loma Linda University (LLU)

Status: Completed

Conditions: Hydrostatic Vacuum Casting

Treatments: Other: vacuum casting; Other: hydrostatic casting

Study type: Interventional

Funder types: Other

Identifiers

NCT03891017

5180404

Details and patient eligibility

About

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.

Full 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

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria :

• 18 years of age or older
• Trans-tibial amputation, unilateral
• Able to walk for a six-minute minimum w/o a break
• Amputation history of at least 6 months

Exclusion criteria:

• Syme amputation
• Physical disability or injury affecting a natural gait pattern
• Ulcers or blisters on the residual limb

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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7 participants in 2 patient groups

vacuum casting

Experimental group

Description:

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

Treatment:

Other: vacuum casting

hydrostatic casting

Active Comparator group

Description:

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

Treatment:

Other: hydrostatic casting