Clinical trial NCT04326712: The Effect of Different Measurement-manufacturing Techniques on Load Distribution in Amputees
Official title: The Effect of Different Measurement-manufacturing Techniques on Stump and Soles Load Distribution in Transtibial Knee Prostheses
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Transtibial Amputee
Loading
Conventional
3D
Keywords: amputee, loading, 3D
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2020-03-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Unilateral transtibial amputees

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.


Eligibility criteria: 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

Primary outcomes:
measure: Measurement of load distrubution on stump in conventional manufactured socket
timeFrame: Change from load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during walking
measure: Measurement of load distrubution on stump in 3D manufactured socket
timeFrame: Change from load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during walking
measure: Measurement of load distrubution on stump in conventional manufactured socket
timeFrame: Change from load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during climbing up and down stairs.
measure: Measurement of load distrubution on stump in 3D-manufactured socket
timeFrame: Change from load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during climbing up and down stairs
measure: Measurement of sole load distrubution (mmHg/N/Kg) in conventional manufactured socket
timeFrame: Change from sole load distrubution (mmHg/N/Kg) will be measured with F-socket film sensories during walking
measure: Measurement of sole load distrubution (mmHg/N/Kg) in 3D-manufactured socket
timeFrame: Change from sole load distrubution (mmHg/N/Kg) will be measured with F-socket film sensories during walking
measure: Measurement of sole load distrubution (mmHg/N/Kg) in conventional manufactured socket
timeFrame: Change from sole load distrubution (mmHg/N/Kg) will be measured with F-socket film sensories during climbing up and down stairs
measure: Measurement of sole load distrubution (mmHg/N/Kg) in 3D-manufactured socket
timeFrame: Change from sole load distrubution (mmHg/N/Kg) will be measured with F-socket film sensories during climbing up and down stairs
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University
Study officials:
affiliation: Marmara University
name: yasar tatar
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.