Computational Design, Fabrication, and Evaluation of Optimized Patient-Specific Transtibial Prosthetic Sockets

NCT03544853 | Completed

• 2 other identifiers: 1101004280R01EB024531-01
• Study Type: interventional
• Target: 10
• Locations: 2 countries
• Sites: 2

Brief Summary

The overall goal of this study is to further develop and clinically assess a computational and data-driven design and manufacturing framework for mechanical interfaces that quantitatively produces transtibial prosthetic sockets in a faster and more cost-effective way than conventional processes. The main hypothesis of this proposal is that the novel quantitative interface is equivalent to, or better than, a conventional interface in terms of: 1) gait symmetry, 2) skin contact pressures, 3) skin surface temperature, and 4) comfort as evaluated from a questionnaire.

Conditions

Amputation Stump

Keywords

Prosthetic socket; Biomechanics

Outcome Measures

Primary Outcomes (4)

• Local skin pressure while wearing a socket

  Local skin contact pressures (in Newton per square meter) are assessed using pressure sensors positioned on the skin surface. Local pressures relate to comfort which is the topic of investigation. These measurements are performed during the (clinical) socket comfort evaluation phase which is typically 3 months after the initial data acquisition phase for each subject. Measurements take place once and in a single session. As such only a single time point is investigated (the time point of the experiment is not a relevant or investigated parameter). The data is compared across subjects and socket types.

  Assessed once during (clinical) socket comfort evaluation phase. Measurements are for standing and walking exercises for the conventional and novel socket.

• Skin surface temperature difference

  Skin surface temperatures (in Celsius) are assessed using a Flir thermal camera, with images taken immediately post-kinematic walking trial. From these measurements the average residuum skin surface temperature is assessed for 4 different view directions: anterior, posterior, medial, and lateral. Measurements take place once and in a single session. As such only a single time point is investigated (the time point of the experiment is not a relevant or investigated parameter). The data is compared across subjects and socket types.

  Assessed once during (clinical) socket comfort evaluation phase. Measurements are for standing and walking exercises for the conventional and novel socket.

• Gait parameter asymmetry

  Socket fit (and discomfort) influences musculoskeletal behavior and may alter gait patterns. Subjects are equipped with markers tracked (units of mm) using a motion capture system (T40s, Vicon Motion Systems Ltd, Oxford, UK). Ground reaction forces (units Newton) are also recorded. From these measurements gait symmetry indices for: joint angles, positions, torques, and ground reaction forces, are computed. These measurements are performed during the (clinical) socket comfort evaluation phase which is typically 3 months after the initial data acquisition phase for each subject. Measurements take place once and in a single session. As such only a single time point is investigated (the time point of the experiment is not a relevant or investigated parameter). The data is compared across subjects and socket types.

  Assessed once during (clinical) socket comfort evaluation phase. Measurements are for standing and walking exercises for the conventional and novel socket.

• Socket evaluation questionnaire

  Socket fit and discomfort is assessed using a questionnaire created to document patient experiences and preferences while using prosthetic interfaces (liners, sockets) both over a longitudinal timeline and on an immediate basis. After establishing subject baselines for socket use, patients complete a section that instructs them to evaluate the novel prosthetic socket provided against their conventional prosthetic socket. Subjects complete the questionnaire via a HIPAA compliant surveying instrument on Redcap, and questions are tailored to minimize bias through adoption of verified metrics (such as those from the TAPES-R instrument) or by the use of sliding scales that eliminate the need for constrained integer number input. The data is analyzed by subject, across subjects as a whole, and socket types.

  Assessed once during (clinical) socket comfort evaluation phase. Measurements are for sitting, standing and walking exercises for the conventional and novel socket.

Study Arms (1)

Prosthetic socket evaluation

EXPERIMENTAL

Intervention: Prosthetic socket for transtibial amputee. A subject's conventional prosthetic socket is compared to a novel prosthetic socket designed as part of the research. For standing and walking exercises the following will be assessed. 1) local skin contact pressures, 2) metabolic power, 3) gait parameters (symmetry indices for joint angles, positions, torques, and also ground reaction forces), and 4) the socket evaluation questionnaire.

Device: Prosthetic socket for transtibial amputee

Interventions

Prosthetic socket for transtibial amputee DEVICE

To wear a prosthetic socket for evaluation of comfort and biomechanical metrics such as skin loading conditions.

Prosthetic socket evaluation

Eligibility Criteria

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

You may qualify if:

• Age: 18-64 years old
• Amputation type: Transtibial amputation (bilateral or unilateral) which took place \>1 year prior to study
• Activity or K-level: At least K3
• Socket quality: The subject's conventional socket(s) should be deemed of high quality and comfortable
• MRI safety: Subjects should be able to undergo MRI

Sponsors & Collaborators

• Massachusetts Institute of Technology: lead
• National Institute for Biomedical Imaging and Bioengineering (NIBIB): collaborator

Study Sites (2)

Massachusetts Institute of Technology, Media Lab

Cambridge, Massachusetts, 02142, United States

Location

Tecnologico de Monterrey, Biomechatronics Lab

Nuevo México, Jalisco, 45201, Mexico

Location

Study Officials

• Hugh M Herr, PhD

  Massachusetts Institute of Technology, Media Lab

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2018
• First Posted: June 4, 2018
• Study Start: September 15, 2017
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: September 30, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); ME (1)