The Asian Transfemoral Prosthetic Socket Study

Effectiveness of Asian Contextual Socket for Transfemoral amputee in Resource Limited Countries: pilot study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20260601020

Enrollment

Registered

2026-06-01

Start date

2021-09-27

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

Unilateral transfemoral amputation Transfemoral limb loss Prosthetic socket fitting Functional limitations in transfemoral amputees Restricted hip motion during floor sitting and kneeling Mobility and comfort in lower limb prosthesis users Transfemoral posthesis Prosthetic socket Above knee amputation Resource limited settings Socket Comfort Floor sitting culture Dynamic balance

Interventions

the experimental socket design to allow for floor sitting, using specific anatomical pressure channels to maintain walking stability without expensive parts,Standard transfemoral prosthetic socket u

Experimental Device,Active Comparator Device

Asian Transfemoral socket,Ischial containment socket

Eligibility

Sex/Gender

All

Age

18 Years to 69 Years

Inclusion criteria

Inclusion criteria: 1 Adult unilateral above knee amputee who has used prothesis for at least 1 year. 2 Short to long length of residual limb 3 Cause of amputation is non-dysvascular 4 Has been a prosthesis user for more than a year 5 Activity level two or higher 6 Body mass index (BMI) between 17 to 30 kg/m2 with weight less than 100 kg 7 Be able to read, understand and write in Thai language

Exclusion criteria

Exclusion criteria: 1 They have more than one major lower limb amputation 2 Any surgical procedure involving the non-amputated side 3 Limitations in hip range of motion (ROM) 4 Manual muscle test grade of less than four on either lower extremity, stump edema, stump wounds and any history of allergic reactions to socket plastics (Polypropylene, Polyester resin) and/or EMG electrode materials (Ag/Cl) 5Problems in comprehension and communication

Design outcomes

Primary

Measure	Time frame
socket comfort after walking test and floor sitting Socket comfort score,Walking performance approximately 5hr familiarization period after optimum fit is achieved Six minute walk test ,dynamic balance approximately 5hr familiarization period after optimum fit is achieved four square stepped test ,Metabolic cost approximately 5hr familiarization period after optimum fit is achieved oxygen consumption during walking test ,Temporal-Spatial Gait Analysis approximately 5hr familiarization period after optimum fit is achieved gait parameters measured using G walk sensor system	—

Measure

Time frame

socket comfort after walking test and floor sitting Socket comfort score,Walking performance approximately 5hr familiarization period after optimum fit is achieved Six minute walk test ,dynamic balance approximately 5hr familiarization period after optimum fit is achieved four square stepped test ,Metabolic cost approximately 5hr familiarization period after optimum fit is achieved oxygen consumption during walking test ,Temporal-Spatial Gait Analysis approximately 5hr familiarization period after optimum fit is achieved gait parameters measured using G walk sensor system

—

Secondary

Measure	Time frame
Hip range of motion after functional performance tests general and floor sitting Hip range of motion measure via kinovea system	—

Countries

Thailand

Contacts

Public ContactKazuhiko Sasaki

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

kazuhiko.sas@mahidol.edu024193465

Outcome results

None listed

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