NCT03891017

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Loma Linda University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Conditions

• Hydrostatic Vacuum Casting

Interventions

Type	Name	Description
OTHER	vacuum casting	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.
OTHER	hydrostatic casting	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.

Timeline

• Start date: 2019-04-01
• Primary completion: 2019-07-01
• Completion: 2019-07-01
• First posted: 2019-03-26
• Last updated: 2019-07-15

Locations

1 site across 1 country: United States