Hydrostatic Vacuum Casting
Conditions
Brief 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
Interventions
OTHERvacuum 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.
OTHERhydrostatic 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.
Sponsors
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Six-Minute Walk Test | between 7-10- days after study enrollment | Participants will walk in a 100-ft hallway on a flat, hard surface in a period of 6 minutes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Volume Calculation | between 7-10- days after study enrollment | 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. |
| Six-Minute Walk Test | between 14-20 days after study enrollment | Participants will walk in a 100-ft hallway on a flat, hard surface in a period of 6 minutes. |
Countries
United States
Outcome results
None listed