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

NCT ID: NCT03390153

Last Updated: 2018-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-02
• Study Completion Date: 2018-08-01

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

semi flexible socket

Intervention Type: OTHER

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 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.

Group Type: ACTIVE_COMPARATOR

rigid fiber socket

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Loma Linda University

OTHER

Sponsor Role: lead

Responsible Party

Gurinder Bains

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gurinder Bains, PhD

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University

Locations

Loma Linda Universtiy

Loma Linda, California, United States

Countries

United States

Other Identifiers

5170454

Identifier Type: -

Identifier Source: org_study_id