The Effect of Different Measurement-manufacturing Techniques on Load Distribution in Amputees

The Effect of Different Measurement-manufacturing Techniques on Stump and Soles Load Distribution in Transtibial Knee Prostheses

Alignment of the prosthesis with the stump is performed through the socket. Good socket stump fit provides near-normal posture and weight-transfer pattern. It also ensures that the walk is painless and low-energy. Recently, studies have been carried out to use 3D printers in socket production. 3D method is accepted as an effective and reliable method in prosthetic socket production. The purpose of this study is to compare the pressures distrubution in the sockets produced by conventional and 3D scanners and printers in the transtibial amputee.

Study Overview

• Status: Unknown
• Conditions: Transtibial Amputee; Loading; Conventional; 3D
• Intervention / Treatment: Other: conventional manufactured socket; Other: 3D manufactured socket

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34000
    • Marmara University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Unilateral transtibial amputees

Description

Inclusion Criteria:

• Being unilateral transtibial amputation
• To have enough perception level to understand and apply commands

Exclusion Criteria:

• To have orthopedic, neurological, etc. disorder other than amputation that will affect posture or gait
• The presence of pain that will affect the posture or walking pattern
• Wound / tenderness on the stump
• Visual impairment that will affect the posture or gait pattern
• Use of any assistive device (walking stick, canary, etc.) during walking

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Unilateral transtibial amputees using conventinional manufactured socket	Other: conventional manufactured socket; Presssure disturubition will be measured in conventional manufactured socket during walking and stairing up and down activities in unilateral transtibial amputees
Group 2; Unilateral transtibial amputees using 3D manufactured socket	Other: 3D manufactured socket; Presssure disturubition will be measured in 3D manufactured socket during walking and stairing up and down activities in unilateral transtibial amputees

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of load distrubution on stump in conventional manufactured socket	Load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during walking.	Change from load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during walking
Measurement of load distrubution on stump in 3D manufactured socket	Load distrubution (mmHg/N/Kg) on stump will be measured with F-socket sensories during walking.	Change from load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during walking
Measurement of load distrubution on stump in conventional manufactured socket	Load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during climbing up and down stairs.	Change from load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during climbing up and down stairs.
Measurement of load distrubution on stump in 3D-manufactured socket	Load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during climbing up and down stairs	Change from load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during climbing up and down stairs
Measurement of sole load distrubution (mmHg/N/Kg) in conventional manufactured socket	Sole load distrubution (mmHg/N/Kg) will be measured with F-scan sensories during walking	Change from sole load distrubution (mmHg/N/Kg) will be measured with F-socket film sensories during walking
Measurement of sole load distrubution (mmHg/N/Kg) in 3D-manufactured socket	Sole load distrubution (mmHg/N/Kg) will be measured with F-scan sensories during walking	Change from sole load distrubution (mmHg/N/Kg) will be measured with F-socket film sensories during walking
Measurement of sole load distrubution (mmHg/N/Kg) in conventional manufactured socket	Sole load distrubution (mmHg/N/Kg) will be measured with F-scan sensories during climbing up and down stairs	Change from sole load distrubution (mmHg/N/Kg) will be measured with F-socket film sensories during climbing up and down stairs
Measurement of sole load distrubution (mmHg/N/Kg) in 3D-manufactured socket	Sole load distrubution (mmHg/N/Kg) will be measured with F-scan sensories during climbing up and down stairs	Change from sole load distrubution (mmHg/N/Kg) will be measured with F-socket film sensories during climbing up and down stairs

Collaborators and Investigators

• Sponsor: Marmara University
• Investigators: Study Director: yasar tatar, Marmara University

Publications and helpful links

General Publications

• Dou P, Jia X, Suo S, Wang R, Zhang M. Pressure distribution at the stump/socket interface in transtibial amputees during walking on stairs, slope and non-flat road. Clin Biomech (Bristol, Avon). 2006 Dec;21(10):1067-73. doi: 10.1016/j.clinbiomech.2006.06.004. Epub 2006 Aug 17.
• Jia X, Suo S, Meng F, Wang R. Effects of alignment on interface pressure for transtibial amputee during walking. Disabil Rehabil Assist Technol. 2008 Nov;3(6):339-43. doi: 10.1080/17483100802044634.
• Xiaohong J, Xiaobing L, Peng D, Ming Z. The Influence of Dynamic Trans-tibial Prosthetic Alignment on Standing Plantar Foot Pressure. Conf Proc IEEE Eng Med Biol Soc. 2005;2005:6916-8. doi: 10.1109/IEMBS.2005.1616096.
• Lee VS, Solomonidis SE, Spence WD. Stump-socket interface pressure as an aid to socket design in prostheses for trans-femoral amputees--a preliminary study. Proc Inst Mech Eng H. 1997;211(2):167-80. doi: 10.1243/0954411971534287.

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2019
• Primary Completion (Anticipated): April 10, 2020
• Study Completion (Anticipated): June 30, 2020

Study Registration Dates

• First Submitted: March 25, 2020
• First Submitted That Met QC Criteria: March 27, 2020
• First Posted (Actual): March 30, 2020

Study Record Updates

• Last Update Posted (Actual): March 30, 2020
• Last Update Submitted That Met QC Criteria: March 27, 2020
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: amputee, loading, 3D
• Other Study ID Numbers: 09.2019.359

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No