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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Hydrostatic Vacuum Casting

Intervention / Treatment
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* Other: vacuum casting
* Other: hydrostatic casting


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vacuum casting<br>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 | Other: vacuum casting<br>* 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.<br>|
| Active Comparator: hydrostatic casting<br>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 | Other: hydrostatic casting<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | between 14-20 days after study enrollment |