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

NCT03390153 | Completed

• 1 other identifier: 5170454
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Amputation

Outcome Measures

Primary Outcomes (1)

• 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.

  Change in balance between Week 2 and Week 3 of study

Secondary Outcomes (1)

• Socket liner integrity

  Change in socket liner between Week 2 and Week 3 of study

Study Arms (2)

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.

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.

Other: rigid fiber socket

Interventions

semi flexible socket 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.

semi flexible socket group

rigid fiber socket 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda Universtiy

Loma Linda, California, 92350, United States

Location

Study Officials

• Gurinder Bains, PhD

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 14, 2017
• First Posted: January 4, 2018
• Study Start: April 2, 2018
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: September 25, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)