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

NACompletedINTERVENTIONAL
Enrollment

7

Participants

Timeline

Start Date

April 1, 2019

Primary Completion Date

July 1, 2019

Study Completion Date

July 1, 2019

Conditions
Hydrostatic Vacuum Casting
Interventions
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.

Trial Locations (1)

92350

Loma Linda Universtiy, Loma Linda

All Listed Sponsors
lead

Loma Linda University

OTHER

NCT03891017 - Qualitative & Quantitative Comparison of Hydrostatic vs Vacuum Casting Methods in Trans-Tibial Amputees | Biotech Hunter | Biotech Hunter