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

NCT ID: NCT04326712

Last Updated: 2020-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-06

Study Completion Date

2020-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Transtibial Amputee Loading Conventional 3D

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Unilateral transtibial amputees using conventinional manufactured socket

conventional manufactured socket

Intervention Type OTHER

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

3D manufactured socket

Intervention Type OTHER

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

Interventions

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conventional manufactured socket

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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Marmara University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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yasar tatar

Role: STUDY_DIRECTOR

Marmara University

Locations

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Marmara University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 16919376 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19127605 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17281865 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9184457 (View on PubMed)

Other Identifiers

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09.2019.359

Identifier Type: -

Identifier Source: org_study_id

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