AmputationNCT03390153
Reduction of Shear Forces Using Semi-flexible Sockets on Transtibial Amputees
A study testing semi flexible socket and rigid fiber socket in people with Amputation, run by Loma Linda University at 1 site in United States.
Trial summary
The purpose of this graduate student research study, is to test two different sockets for comfort and test what pressures are created by the socket during daily activities. The objective is to illustrate that semi-flexible sockets will maintain its rigidity and resist progressive shear forces from daily activity, ergo… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Amputation
- What is being tested?
- semi flexible socket and rigid fiber socket
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2018to 1 Aug 2018
- 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
- Transtibial amputee with mature limb
- Minimum of 3-years of prosthetic use
- Capable of ambulating on a treadmill for ten minutes
- Minimum age of 18 years old
- Both Unilateral and Bilateral Amputees
- K-Level K2-K4
Who cannot join
- Any open wounds/ulcerations on the residual limb
- Skin allergies to silicone or latex
- Unmanaged co-morbidities such a diabetes and congestive heart failure
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this graduate student research study, is to test two different sockets for comfort and test what pressures are created by the socket during daily activities. The objective is to illustrate that semi-flexible sockets will maintain its rigidity and resist progressive shear forces from daily activity, ergo making our prosthetic system a more comfortable experience for the prosthetic user.
Read the detailed description
Subjects will immediately be prepared for a casting of their residual limb. On the second visit, subjects will return to be fitted with a definitive rigid carbon fiber socket. At this time, a questionnaire and physical assessments will determine subjects comfort and safety. The physical assessment consists of a ten minute walk on a treadmill, at a self-selected pace. A balancing test on a SMART Balance Master will also be used to assess subject safety, by utilizing the limits of stability protocol. Subjects' will be required to wear the prosthesis given to them for one week before returning for a follow-up appointment. On the third visit, the subjects' will return the first prosthesis to the investigators of the study, where an additional socket will be given to the subject for the second portion of this study. Subjects will be evaluated with a questionnaire and physical assessments to determine comfort and safety. Participants will be required to wear the prosthesis given to them for one week before returning for a follow-up appointment. During the final appointment, the subjects will return all devices given to them to an investigator of the study.
- Conditions
- Amputation
- Being tested
- semi flexible socket, rigid fiber socket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semi flexible socketOther
The investigators will analyze the subject's gait by trained visual diagnosis and video gait analysis, to determine comfort and safety. Any modifications will be done at this time. Once the subjects, student, and faculty investigators are satisfied with the overall fit of prostheses, a student investigator will insert force sensors into the socket to evaluate pressure. In the 'Comfort Test', walk at a self-selected pace on a treadmill for 10 minutes. Subjects will then perform a single stance activity on a Balance Master. Investigators will remove the force sensors and do one final safety check of prostheses before each subject takes their definitive socket home. Subjects will be required to wear the prosthesis given to them for one week before returning for a follow up appointment.
rigid fiber socketOther
The investigators will analyze the subject's gait by trained visual diagnosis and video gait analysis, to determine comfort and safety. Any modifications will be done at this time. Once the subjects, student, and faculty investigators are satisfied with the overall fit of prostheses, a student investigator will insert force sensors into the socket to evaluate pressure. In the 'Comfort Test', walk at a self-selected pace on a treadmill for 10 minutes. Subjects will then perform a single stance activity on a Balance Master. Investigators will remove the force sensors and do one final safety check of prostheses before each subject takes their definitive socket home. Subjects will be required to wear the prosthesis given to them for one week before returning for a follow up appointment.
| Study group | Role | What they receive |
|---|---|---|
| semi flexible socket group | Experimental | A new form of residuum containment is the semi-flexible carbon fiber prosthetic socket. A semi-flexible carbon fiber socket is constructed with the same security for the subject in mind, and is even more lightweight than a rigid socket. The carbon fiber and resin used in a semi-flexible socket may provide the same durability and stability as previous designs, but will deform, intentionally, without failing (breaking). This distinct feature of semi-flexible sockets makes them a potential option for people living with limb loss. By moving slightly with the residual limb, the socket-user-interface should experience fewer forces/stresses, and yield greater comfort for the prosthetic user. Receives: Other: semi flexible socket |
| rigid fiber socket group | Active comparator | A rigid carbon fiber socket is constructed for security and is mechanically lightweight to ensure stability and efficient build height. Carbon is used for its durability and stability. It proves to be a detriment in comfort and flexibility. The standard for carbon fiber weaves come in two forms: Unidirectional (UD) and Bidirectional (BD). UD carbon fiber has a zero-degree alignment, which is highly durable when compressed, but has low torsional durability. The BD carbon fibers are aligned in a 90 degree angle allowing for moderate compression and torsional strength. When oriented at 45 degrees to the line of progression, fibers become more flexible and exhibit greater torsional strength. Resins and glass composites are added to ensure security and sturdiness. Receives: Other: rigid fiber socket |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance
The SMART Balance Master is a device used to measure balance. It consists of a plate with force sensors that can measure the subject's center of gravity as the subject shifts their position back and forth through the exercise. We will be exerting the subjects through the different phases of gait also known as a Limits of Stability test, one of the many pre-programed tests available to choose from.The SMART Balance Master is a widely used device in the rehabilitation world to test an individual's balance and ascertain their functional limits. It is a device that has great repeatability and is used to test individuals rehabilitation progress. It is also used extensively in research due to its high reproducibility. The SMART Balance Master is manufactured by Natus Medical Incorporated which is located in Pleasanton California.
Measured: Change in balance between Week 2 and Week 3 of study
Secondary outcomes (1)
Socket liner integrity
The Socket Liner Integrity Checklist (SLIC) has been developed by one of our student investigators which has worked in the industry for 9 years. The SLIC will be used to evaluate the wear that the socket exerts on the liner. We hypothesize that semi-flexible sockets will reduce wear of the liner, and we will use the SLIC to evaluate. The semi-flexible socket will also need to be evaluated. A semi-flexible socket might be a more comfortable experience for the user but if it does not hold up to the rigours of daily activities wear and tear, it is not a better alternative. This checklist will focus on specific areas of that socket which are prone to failure to more easily catch any major flaws.
Measured: Change in socket liner between Week 2 and Week 3 of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2018
- Study start2 Apr 2018
- Primary completion1 Aug 2018
- Study completion1 Aug 2018
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.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- 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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gurinder Bains, Loma Linda University
- Investigators
- Gurinder Bains, PhD, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03390153
- Sponsor's protocol ID
- 5170454
- Status last verified
- Sep 2018
- First submitted
- 14 Dec 2017
- Last updated
- 25 Sep 2018
- 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 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Shear Forces Using Semi-flexible Sockets on Transtibial Amputees
- ClinicalTrials.gov ID
- NCT03390153
- Acronym / sponsor ID
- 5170454
- Conditions
- Amputation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 2 Apr 2018 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 4 Jan 2018 (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 student research study, is to test two different sockets for comfort and test what pressures are created by the socket during daily activities. The objective is to illustrate that semi-flexible sockets will maintain its rigidity and resist progressive shear forces from daily activity, ergo making our prosthetic system a more comfortable experience for the prosthetic user.
Detailed description
Subjects will immediately be prepared for a casting of their residual limb. On the second visit, subjects will return to be fitted with a definitive rigid carbon fiber socket. At this time, a questionnaire and physical assessments will determine subjects comfort and safety. The physical assessment consists of a ten minute walk on a treadmill, at a self-selected pace. A balancing test on a SMART Balance Master will also be used to assess subject safety, by utilizing the limits of stability protocol. Subjects' will be required to wear the prosthesis given to them for one week before returning for a follow-up appointment. On the third visit, the subjects' will return the first prosthesis to the investigators of the study, where an additional socket will be given to the subject for the second portion of this study. Subjects will be evaluated with a questionnaire and physical assessments to determine comfort and safety. Participants will be required to wear the prosthesis given to them for one week before returning for a follow-up appointment. During the final appointment, the subjects will return all devices given to them to an investigator of the study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| semi flexible socket group | Experimental | Other: semi flexible socketA new form of residuum containment is the semi-flexible carbon fiber prosthetic socket. A semi-flexible carbon fiber socket is constructed with the same security for the subject in mind, and is even more lightweight than a rigid socket. The carbon fiber and resin used in a semi-flexible socket may provide the same durability and stability as previous designs, but will deform, intentionally, without failing (breaking). This distinct feature of semi-flexible sockets makes them a potential option for people living with limb loss. By moving slightly with the residual limb, the socket-user-interface should experience fewer forces/stresses, and yield greater comfort for the prosthetic user. |
| rigid fiber socket group | Active comparator | Other: rigid fiber socketA rigid carbon fiber socket is constructed for security and is mechanically lightweight to ensure stability and efficient build height. Carbon is used for its durability and stability. It proves to be a detriment in comfort and flexibility. The standard for carbon fiber weaves come in two forms: Unidirectional (UD) and Bidirectional (BD). UD carbon fiber has a zero-degree alignment, which is highly durable when compressed, but has low torsional durability. The BD carbon fibers are aligned in a 90 degree angle allowing for moderate compression and torsional strength. When oriented at 45 degrees to the line of progression, fibers become more flexible and exhibit greater torsional strength. Resins and glass composites are added to ensure security and sturdiness. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Transtibial amputee with mature limb
- Minimum of 3-years of prosthetic use
- Capable of ambulating on a treadmill for ten minutes
- Minimum age of 18 years old
- Both Unilateral and Bilateral Amputees
Key exclusion criteria (3 listed)
- Any open wounds/ulcerations on the residual limb
- Skin allergies to silicone or latex
- Unmanaged co-morbidities such a diabetes and congestive heart failure
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 |
|---|---|---|
| semi flexible socketThe investigators will analyze the subject's gait by trained visual diagnosis and video gait analysis, to determine comfort and safety. Any modifications will be done at this time. Once the subjects, student, and faculty investigators are satisfied with the overall fit of prostheses, a student investigator will insert force sensors into the socket to evaluate pressure. In the 'Comfort Test', walk at a self-selected pace on a treadmill for 10 minutes. Subjects will then perform a single stance activity on a Balance Master. Investigators will remove the force sensors and do one final safety check of prostheses before each subject takes their definitive socket home. Subjects will be required to wear the prosthesis given to them for one week before returning for a follow up appointment. | Other | semi flexible socket group |
| rigid fiber socketThe investigators will analyze the subject's gait by trained visual diagnosis and video gait analysis, to determine comfort and safety. Any modifications will be done at this time. Once the subjects, student, and faculty investigators are satisfied with the overall fit of prostheses, a student investigator will insert force sensors into the socket to evaluate pressure. In the 'Comfort Test', walk at a self-selected pace on a treadmill for 10 minutes. Subjects will then perform a single stance activity on a Balance Master. Investigators will remove the force sensors and do one final safety check of prostheses before each subject takes their definitive socket home. Subjects will be required to wear the prosthesis given to them for one week before returning for a follow up appointment. | Other | rigid fiber socket group |
Primary outcome
Balance
Time frame: Change in balance between Week 2 and Week 3 of study
The SMART Balance Master is a device used to measure balance. It consists of a plate with force sensors that can measure the subject's center of gravity as the subject shifts their position back and forth through the exercise. We will be exerting the subjects through the different phases of gait also known as a Limits of Stability test, one of the many pre-programed tests available to choose from.The SMART Balance Master is a widely used device in the rehabilitation world to test an individual's balance and ascertain their functional limits. It is a device that has great repeatability and is used to test individuals rehabilitation progress. It is also used extensively in research due to its high reproducibility. The SMART Balance Master is manufactured by Natus Medical Incorporated which is located in Pleasanton California.
1 secondary outcome
Socket liner integrity
Time frame: Change in socket liner between Week 2 and Week 3 of study
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 25 Sep 2018.
- Individual participant dataSharing planned: No
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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.
Gurinder Bains, PhD 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 semi flexible socket and rigid fiber socket in people with Amputation, 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 6 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 25 Sep 2018. 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?
Balance (time frame: Change in balance between Week 2 and Week 3 of study). 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 25 Sep 2018.