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Completed

NCT Number: NCT03891017

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

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.

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Key information

Conditions

Hydrostatic Vacuum Casting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loma Linda Universtiy

Loma Linda, California, 92350, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

vacuum casting

Other

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

Other

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 26, 2019
Registry last updated
Jul 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.