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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04326712
Enrollment
30
Registered
2020-03-30
Start date
2019-09-06
Completion date
2020-06-30
Last updated
2020-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

3D, Conventional, Loading, Transtibial Amputee

Keywords

amputee, loading, 3D

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.

Interventions

OTHERconventional manufactured socket

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

OTHER3D manufactured socket

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

Sponsors

Marmara University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Measurement of load distrubution on stump in conventional manufactured socketChange from load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during walkingLoad distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during walking.
Measurement of load distrubution on stump in 3D manufactured socketChange from load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during walkingLoad distrubution (mmHg/N/Kg) on stump will be measured with F-socket sensories during walking.
Measurement of load distrubution on stump in 3D-manufactured socketChange from load distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during climbing up and down stairsLoad distrubution (mmHg/N/Kg) on stump will be measured with F-socket film sensories during climbing up and down stairs
Measurement of sole load distrubution (mmHg/N/Kg) in conventional manufactured socketChange from sole load distrubution (mmHg/N/Kg) will be measured with F-socket film sensories during walkingSole load distrubution (mmHg/N/Kg) will be measured with F-scan sensories during walking
Measurement of sole load distrubution (mmHg/N/Kg) in 3D-manufactured socketChange from sole load distrubution (mmHg/N/Kg) will be measured with F-socket film sensories during walkingSole load distrubution (mmHg/N/Kg) will be measured with F-scan sensories during walking

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026