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

Transtibial Amputee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04326712
• Other study ID #: 09.2019.359
• Status: Active, not recruiting
• Start date: September 6, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: April 2019
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: June 30, 2020
• Est. primary completion date: April 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• 3D
• Conventional
• Loading
• Transtibial Amputee

Intervention

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

Locations

Country	Name	City	State
Turkey	Marmara University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

References & 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, Avon). 2006 Dec;21(10):1067-73. Epub 2006 Aug 17. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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.
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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