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

Hydrostatic Vacuum Casting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03891017
• Other study ID #: 5180404
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: July 1, 2019

Study information

• Verified date: July 2019
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: July 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hydrostatic Vacuum Casting

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Loma Linda Universtiy	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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