Hydrostatic Vacuum CastingNCT03891017
Qualitative & Quantitative Comparison of Hydrostatic vs Vacuum Casting Methods in Trans-Tibial Amputees
A study testing vacuum casting and hydrostatic casting in people with Hydrostatic Vacuum Casting, run by Loma Linda University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hydrostatic Vacuum Casting
- What is being tested?
- vacuum casting and hydrostatic casting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 1 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Syme amputation
- Physical disability or injury affecting a natural gait pattern
- Ulcers or blisters on the residual limb
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Hydrostatic Vacuum Casting
- Being tested
- vacuum casting, hydrostatic casting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vacuum castingOther
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 castingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| vacuum casting | Experimental | 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 Receives: Other: vacuum casting |
| hydrostatic casting | Active comparator | 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 Receives: Other: hydrostatic casting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six-Minute Walk Test
Participants will walk in a 100-ft hallway on a flat, hard surface in a period of 6 minutes.
Measured: between 7-10- days after study enrollment
Secondary outcomes (3)
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.
Measured: between 7-10- days after study enrollment
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.
Measured: between 14-20 days after study enrollment
Six-Minute Walk Test
Participants will walk in a 100-ft hallway on a flat, hard surface in a period of 6 minutes.
Measured: between 14-20 days after study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start1 Apr 2019
- Primary completion1 Jul 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hydrostatic Vacuum CastingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heather Appling, Loma Linda University
- Investigators
- Heather Appling, MSOP, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03891017
- Sponsor's protocol ID
- 5180404
- Status last verified
- Jul 2019
- First submitted
- 18 Mar 2019
- Last updated
- 15 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qualitative & Quantitative Comparison of Hydrostatic vs Vacuum Casting Methods in Trans-Tibial Amputees
- ClinicalTrials.gov ID
- NCT03891017
- Acronym / sponsor ID
- 5180404
- Conditions
- Hydrostatic Vacuum Casting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 26 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vacuum casting | Experimental | Other: vacuum castingVacuum 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 |
| hydrostatic casting | Active comparator | Other: hydrostatic castingFor 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Syme amputation
- Physical disability or injury affecting a natural gait pattern
- Ulcers or blisters on the residual limb
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vacuum castingParticipants 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 | vacuum casting |
| hydrostatic castingParticipants 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. | Other | hydrostatic casting |
Primary outcome
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.
3 secondary outcomes
Volume Calculation
Time frame: between 7-10- days after study enrollment
Volume Calculation
Time frame: between 14-20 days after study enrollment
Six-Minute Walk Test
Time frame: between 14-20 days after study enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2019.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather Appling, MSOP principal investigator
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vacuum casting and hydrostatic casting in people with Hydrostatic Vacuum Casting, run by Loma Linda University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six-Minute Walk Test (time frame: between 7-10- days after study enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2019.