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

• Conditions: Transtibial Amputee; Loading; 3D; Conventional
• Interventions: Other: conventional manufactured socket; Other: 3D manufactured socket

• Registration Number: NCT04326712
• Lead Sponsor: Marmara University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-04
• Study Start: 2019-09-06
• Study First Submitted: 2020-03-25
• Study First Submitted QC: 2020-03-27
• Last Update Submitted: 2020-03-27
• Study First Posted: 2020-03-30
• Last Update Posted: 2020-03-30
• Primary Completion: 2020-04-10
• Study Completion: 2020-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	conventional manufactured socket	Unilateral transtibial amputees using conventinional manufactured socket
Group 2	3D manufactured socket	Unilateral transtibial amputees using 3D manufactured socket

Primary Outcome Measures

Name	Time	Method
Measurement of load distrubution on stump in conventional manufactured socket	Change from load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during climbing up and down stairs.	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	Change from load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during climbing up and down stairs	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	Change from load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during walking	Load distrubution (mmHg/N/Kg) on stump will be measured with F-socket sensories during walking.
Measurement of sole load distrubution (mmHg/N/Kg) in conventional manufactured socket	Change from sole load distrubution (mmHg/N/Kg) will be measured with F-socket film sensories during climbing up and down stairs	Sole load distrubution (mmHg/N/Kg) will be measured with F-scan sensories during climbing up and down stairs
Measurement of sole load distrubution (mmHg/N/Kg) in 3D-manufactured socket	Change from sole load distrubution (mmHg/N/Kg) will be measured with F-socket film sensories during climbing up and down stairs	Sole load distrubution (mmHg/N/Kg) will be measured with F-scan sensories during climbing up and down stairs

Trial Locations

Locations (1)

Marmara University; 🇹🇷 Istanbul, Turkey