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Reduction of Shear Forces Using Semi-flexible Sockets on Transtibial Amputees

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ClinicalTrials.gov Identifier: NCT03390153
Recruitment Status : Recruiting
First Posted : January 4, 2018
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
Gurinder Bains, Loma Linda University

Brief 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 making our prosthetic system a more comfortable experience for the prosthetic user.

Condition or disease Intervention/treatment Phase
Amputation Other: semi flexible socket Other: rigid fiber socket Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Reduction of Shear Forces Using Semi-flexible Sockets on Transtibial Amputees
Actual Study Start Date : April 2, 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Limb Loss

Arm Intervention/treatment
Experimental: semi flexible socket group
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.
Other: semi flexible socket
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.

Active Comparator: rigid fiber socket group
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.
Other: rigid fiber socket
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Socket liner integrity [ Time Frame: Change in socket liner between Week 2 and Week 3 of study ]
    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.



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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:

  • 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

Exclusion Criteria:

  • Any open wounds/ulcerations on the residual limb
  • Skin allergies to silicone or latex
  • Unmanaged co-morbidities such a diabetes and congestive heart failure

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): NCT03390153


Contacts
Contact: Gurinder Bains, PhD 909-558-7274 ext 87274 gbains@llu.edu

Locations
United States, California
Loma Linda Universtiy Recruiting
Loma Linda, California, United States, 92350
Contact: Gurinder Bains, PhD         
Sponsors and Collaborators
Loma Linda University
Investigators
Principal Investigator: Gurinder Bains, PhD Loma Linda University

Responsible Party: Gurinder Bains, Associate Professor, Loma Linda University
ClinicalTrials.gov Identifier: NCT03390153     History of Changes
Other Study ID Numbers: 5170454
First Posted: January 4, 2018    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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