AmputationPhase 1NCT01559909
Effect of Socket Wall Height With Vacuum Suspension for Above Knee Amputees
A Phase 1 study testing Vacuum assisted socket technology (Harmony System, Otto Bock Healthcare) in people with Amputation, run by Stony Brook University at 2 sites in United States.
Trial summary
Individuals with transfemoral (TF) amputation (above the knee amputation) may benefit from a socket that uses vacuum assisted suspension (VAS) to hold the socket onto the amputated limb. VAS may improve stability, weight bearing, comfort, proprioception, limb health, and function. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Amputation
- What is being tested?
- Vacuum assisted socket technology (Harmony System, Otto Bock Healthcare)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2012to Dec 2013
- Phase
- Phase 1
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female between the ages of 21 and 75 with a transfemoral amputation.
- Limited household ambulators (K1) to those considered unlimited community ambulators (K4).
- People who are comfortably fitted with a prosthesis for at least 6 months.
Who cannot join
- People with severe cardiac or pulmonary disease that limits ability to walk.
- People with too much discomfort and/or pain.
- People with active wounds on their residual limb or other foot.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Stony Brook University
Stony Brook, New York, 11794'
Long Island Orthotics and Prosthetics
West Babylon, New York, 11704
About this study
Official title: Effect of Brim Height Using Vacuum Assisted Technology With Transfemoral Amputees
Individuals with transfemoral (TF) amputation (above the knee amputation) may benefit from a socket that uses vacuum assisted suspension (VAS) to hold the socket onto the amputated limb. VAS may improve stability, weight bearing, comfort, proprioception, limb health, and function. To date, there is no evidence to support whether VAS alters balance, kinematics, and kinetics when walking for TF amputees as compared to conventional socket suspension technology. Further, there is question regarding what the optimal height of the socket should be to maintain stability and function. So long as stability is not sacrificed, it may be advantageous to lower the height of the socket to allow full hip motion and improve sitting comfort. The purpose of this investigation is to assess if the socket height alters the motion of the leg and changes the way one walks when using VAS compared to conventional socket suspension technology. In this study, TF amputees will be fitted with a VAS socket that will be attached to their current prosthesis using similar alignment. Individuals will be assessed while walking on a level floor and during stair negotiation while wearing the prosthesis with the VAS socket at various socket heights as well as their current socket. Additionally, balance and socket standing and sitting comfort will be investigated.
- Conditions
- Amputation
- Being tested
- Vacuum assisted socket technology (Harmony System, Otto Bock Healthcare)
- Keywords
- Lower limb loss, Leg amputation, walking study, socket technology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vacuum assisted socket technology (Harmony System, Otto Bock Healthcare)Device
The brim height of the socket will be systematically reduced
| Study group | Role | What they receive |
|---|---|---|
| Socket wall height | Experimental | Not described Receives: Device: Vacuum assisted socket technology (Harmony System, Otto Bock Healthcare) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait changes
Step length, stride length, stance time, swing time, velocity
Measured: 1 day
Secondary outcomes (2)
Comfort
Measured: 1 day
Balance
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Collaborators
- Otto Bock Healthcare Products GmbH
- Responsible party
- Principal investigator, Eric Lamberg, Stony Brook University
- Investigators
- Eric M Lamberg, EdD, PT, Principal investigator, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01559909
- Sponsor's protocol ID
- 197622
- Status last verified
- May 2014
- First submitted
- 16 Aug 2011
- Last updated
- 12 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Brim Height Using Vacuum Assisted Technology With Transfemoral Amputees
- ClinicalTrials.gov ID
- NCT01559909
- Acronym / sponsor ID
- 197622
- Conditions
- Amputation
- Keywords
- Lower limb loss, Leg amputation, walking study, socket technology
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Collaborators
- Otto Bock Healthcare Products GmbH
- Study start
- Jun 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 21 Mar 2012 (estimated)
- 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.
Individuals with transfemoral (TF) amputation (above the knee amputation) may benefit from a socket that uses vacuum assisted suspension (VAS) to hold the socket onto the amputated limb. VAS may improve stability, weight bearing, comfort, proprioception, limb health, and function. To date, there is no evidence to support whether VAS alters balance, kinematics, and kinetics when walking for TF amputees as compared to conventional socket suspension technology. Further, there is question regarding what the optimal height of the socket should be to maintain stability and function. So long as stability is not sacrificed, it may be advantageous to lower the height of the socket to allow full hip motion and improve sitting comfort. The purpose of this investigation is to assess if the socket height alters the motion of the leg and changes the way one walks when using VAS compared to conventional socket suspension technology. In this study, TF amputees will be fitted with a VAS socket that will be attached to their current prosthesis using similar alignment. Individuals will be assessed while walking on a level floor and during stair negotiation while wearing the prosthesis with the VAS socket at various socket heights as well as their current socket. Additionally, balance and socket standing and sitting comfort will be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Socket wall height | Experimental | Device: Vacuum assisted socket technology (Harmony System, Otto Bock Healthcare) |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female between the ages of 21 and 75 with a transfemoral amputation.
- Limited household ambulators (K1) to those considered unlimited community ambulators (K4).
- People who are comfortably fitted with a prosthesis for at least 6 months.
Key exclusion criteria (3 listed)
- People with severe cardiac or pulmonary disease that limits ability to walk.
- People with too much discomfort and/or pain.
- People with active wounds on their residual limb or other foot.
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 assisted socket technology (Harmony System, Otto Bock Healthcare)The brim height of the socket will be systematically reduced | Device | Socket wall height |
Primary outcome
Gait changes
Time frame: 1 day
Step length, stride length, stance time, swing time, velocity
2 secondary outcomes
Comfort
Time frame: 1 day
Balance
Time frame: 1 day
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 12 May 2014.
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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.
Eric M Lamberg, EdD, PT principal investigator
Stony Brook University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vacuum assisted socket technology (Harmony System, Otto Bock Healthcare) in people with Amputation, run by Stony Brook University at 2 sites 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 3 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 12 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Gait changes (time frame: 1 day). 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 12 May 2014.