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

Marmara University

Status: Unknown

Conditions: Transtibial Amputee; 3D; Loading; Conventional

Treatments: Other: 3D manufactured socket; Other: conventional manufactured socket

Study type: Observational

Funder types: Other

Identifiers

NCT04326712

09.2019.359

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 2 patient groups

Group 1

Description:

Unilateral transtibial amputees using conventinional manufactured socket

Treatment:

Other: conventional manufactured socket

Group 2

Description:

Unilateral transtibial amputees using 3D manufactured socket

Treatment:

Other: 3D manufactured socket