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Clinical Applicability of Asian Transfemoral Socket

Clinical Applicability of Asian Transfemoral Socket Design for Primary and Experienced Prosthesis Users in a Real-world Clinical Setting

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
TCTR
Registry ID
TCTR20260610002
Enrollment
30
Registered
2026-06-10
Start date
2024-11-25
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

Transfemoral amputation Lower limb amputation Prosthesis rehabilitation Mobility Transfemoral amputation Asian Transfemoral Socket Prosthetic socket Lower limb prosthesis Socket comfort Mobility Quality of life Rehabilitation

Interventions

Transfemoral amputees including primary prosthesis users and experienced prosthesis users who choose and receive the Asian Transfemoral Socket as part of routine clinical prosthetic care. Each partici
Device Feasibility
Transfemoral prosthesis users

Sponsors

Faculty of Medicine Siriraj Hospital, Mahidol University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1 Unilateral transfemoral amputees: Primary prosthesis users with at least 6 months after amputation or experienced transfemoral prosthesis users 2 Well healed residual limb 3 Residual femur length more than 12 cm 4 Medicare Functional Classification level K2 or higher 5 Body mass index between 17 and 25 kg per square meter or body weight less than 100 kg 6 No hip abduction contracture 7 Able to read, understand, and communicate in Thai

Exclusion criteria

Exclusion criteria: 1 Any medical condition that prevents participation in physical activities or outcome assessments 2 Residual limb complications that interfere with prosthetic fitting or use 3 Problems in comprehension and communication

Design outcomes

Primary

MeasureTime frame
Socket comfort Week 0 Week 4 and Week 12 Socket comfort score ,Functional mobility Week 0 Week 4 and Week 12 Timed up and Go test ,Walking capacity Week 0 Week 4 and Week 12 Two Minute Walk Test

Secondary

MeasureTime frame
Quality of life Week 0 Week 4 and Week 12 Prosthesis Evaluation Questionnaire Thai version

Countries

Thailand

Contacts

Public ContactKazuhiko Sasaki

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

kazuhiko.sas@mahidol.edu0894956465

Outcome results

None listed

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