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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
7
Participants will be cast using vacuum casting (Ottobock Harmony) method. The method of casting will be randomized via RNG. Participants will be fitted with both sockets and dynamic alignment procedures will be performed. This 15-minute fitting and alignment period will address any extreme gait deviations and initial socket discomforts. After fitting, the participant will then be given a 15-minute adjustment period to wear the device. We will then begin the assessment phase, beginning with the timed Get-Up and Go test and followed by the 6-Minute Walk test. Each patient will perform 3 rounds of each test and patient order will be determined at random. The participants will be given a 10 min break between each series of tests. At the end, a questionnaire will be given.
Participants will be cast using aqua casting method. The method of casting will be randomized via RNG. Participants will be fitted with both sockets and dynamic alignment procedures will be performed. This 15-minute fitting and alignment period will address any extreme gait deviations and initial socket discomforts. After fitting, the participant will then be given a 15-minute adjustment period to wear the device. We will then begin the assessment phase, beginning with the timed Get-Up and Go test and followed by the 6-Minute Walk test. Each patient will perform 3 rounds of each test and patient order will be determined at random. The participants will be given a 10 min break between each series of tests. At the end, a questionnaire will be given.
Loma Linda Universtiy
Loma Linda, California, United States
Six-Minute Walk Test
Participants will walk in a 100-ft hallway on a flat, hard surface in a period of 6 minutes.
Time frame: between 7-10- days after study enrollment
Volume Calculation
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.
Time frame: between 7-10- days after study enrollment
Volume Calculation
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.
Time frame: between 14-20 days after study enrollment
Six-Minute Walk Test
Participants will walk in a 100-ft hallway on a flat, hard surface in a period of 6 minutes.
Time frame: between 14-20 days after study enrollment
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