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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03891017
Recruitment Status : Completed
First Posted : March 26, 2019
Last Update Posted : July 15, 2019
Sponsor:
Information provided by (Responsible Party):
Heather Appling, Loma Linda University

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.

Condition or disease Intervention/treatment Phase
Hydrostatic Vacuum Casting Other: vacuum casting Other: hydrostatic casting Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Qualitative & Quantitative Comparison of Hydrostatic vs Vacuum Casting Methods in Trans-Tibial Amputees
Actual Study Start Date : April 1, 2019
Actual Primary Completion Date : July 1, 2019
Actual Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Limb Loss

Arm Intervention/treatment
Experimental: vacuum casting
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
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.

Active Comparator: hydrostatic casting
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
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.




Primary Outcome Measures :
  1. Six-Minute Walk Test [ Time Frame: 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 Outcome Measures :
  1. Volume Calculation [ Time Frame: 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.

  2. Volume Calculation [ Time Frame: between 14-20 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.

  3. Six-Minute Walk Test [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03891017


Locations
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United States, California
Loma Linda Universtiy
Loma Linda, California, United States, 92350
Sponsors and Collaborators
Loma Linda University
Investigators
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Principal Investigator: Heather Appling, MSOP Loma Linda University
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Responsible Party: Heather Appling, Assistant Professor, Loma Linda University
ClinicalTrials.gov Identifier: NCT03891017    
Other Study ID Numbers: 5180404
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No