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Long-term usage of 3d printing prosthetic socket in below knee amputee

The Advancement of prosthetic socket fabrication through 3D printing technology and improving quality of life of prosthesis users for amputee

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260514002
Enrollment
36
Registered
2026-05-14
Start date
2025-10-29
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Transtibial amputation Amputee

Interventions

Sponsors

Faculty of Medicine, Siriraj Hospital, Mahidol University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Transtibial amputation 2. Walk independently with their prosthesis

Exclusion criteria

Exclusion criteria: 1. Bilateral lower limb amputations 2. Neuromuscular diseases affecting gait 3. Patients with edema or very short stump with complex residual limb structure or sensitive skin to the materials used in the 3D printing process. Patients with pain point to the stump / phantom limb pain.

Design outcomes

Primary

MeasureTime frame
Lower limb kinematic data of prosthetic side Immediately after fitting, 1 month follow-up, and 3 months follow-up Lower limb joints range of motion

Secondary

MeasureTime frame
Six-minute walk test Immediately after fitting, 1 month follow-up, and 3 months follow-up Distance,Six-minute walk test Immediately after fitting, 1 month follow-up, and 3 months follow-up Walking Speed, Gait Symmetry Index, Cadence, Stride Length, Left Stance Phase, Right Stance Phase, Left Propulsion, Right Propulsion,Ten-Meter Walk Test Immediately after fitting, 1 month follow-up, and 3 months follow-up Walking Speed, Gait Symmetry Index, Cadence, Stride Length, Left Stance Phase, Right Stance Phase, Left Propulsion, Right Propulsion

Countries

Thailand

Contacts

Public ContactMuhammad Nouman

Sirindhorn School of Prosthetics and Orthotics, Faculty of Medicine, Siriraj Hospital, Mahidol University

muhammad.nou@mahidol.ac.th024193443

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026