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

NCT04326712 | Unknown

• 1 other identifier: 09.2019.359
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Transtibial Amputee; Loading; Conventional; 3D

Keywords

amputee, loading, 3D

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (2)

Group 1

Unilateral transtibial amputees using conventinional manufactured socket

Other: conventional manufactured socket

Group 2

Unilateral transtibial amputees using 3D manufactured socket

Other: 3D manufactured socket

Interventions

conventional manufactured socket OTHER

Presssure disturubition will be measured in conventional manufactured socket during walking and stairing up and down activities in unilateral transtibial amputees

Group 1

3D manufactured socket OTHER

Presssure disturubition will be measured in 3D manufactured socket during walking and stairing up and down activities in unilateral transtibial amputees

Group 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Unilateral transtibial amputees

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University

Istanbul, 34000, Turkey (Türkiye)

Location

Related Publications (4)

• 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). 2006 Dec;21(10):1067-73. doi: 10.1016/j.clinbiomech.2006.06.004. Epub 2006 Aug 17.

  PMID: 16919376 BACKGROUND

• 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.

  PMID: 19127605 BACKGROUND

• 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.

  PMID: 17281865 BACKGROUND

• 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.

  PMID: 9184457 BACKGROUND

Study Officials

• yasar tatar

  Marmara University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2020
• First Posted: March 30, 2020
• Study Start: September 6, 2019
• Primary Completion: April 10, 2020
• Study Completion: June 30, 2020
• Last Updated: March 30, 2020

Record last verified: 2019-04

Locations

TU (1)