Transfemoral amputation Lower limb amputation Prosthesis use Mobility limitation Transfemoral amputation Prosthetic socket Asian Transfemoral Socket Socket comfort Mobility Walking performance Quality of life Lower limb prosthesis
Conditions
Interventions
the experimental socket design to allow for floor sitting, using specific anatomical
pressure channels to maintain walking stability without expensive parts,Participant existing well fitted transfemor
Experimental Device,Active Comparator Device
Asian Transfemoral socket,Participant own prosthetic socket
Sponsors
Faculty of Medicine Siriraj Hospital, Mahidol University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Adult unilateral fine above knee amputee who has Used prosthesis for more than half a year, Can come to center independently without any walking aids and Has a well-fitted current transfemoral device. (2) Medium to a long length of the residual limb (3) Activity level two or higher (4) Body mass index (BMI) between 17 to 25 kg/m2 or less than 100 kg. (5) Be able to read, understand and write in Thai language.
Exclusion criteria
Exclusion criteria: (1) Any co-morbidities that prevent the participant from undertaking any of the physical activities involved in the outcome measurements which are 6MWT (6-minute walk test), 4SST (4 square step test), PEQ (Prosthetic Evaluation Questionnaire), and SCS (Socket comfort score). (2) More than one major lower limb amputation (3) Any surgical procedure involving the non-amputated side (4) Limitations in hip range of motion (ROM) (5) 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 and Acrylic resin) (6) Problems in comprehension and communication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| socket comfort week 3 and week 6 Socket comfort score,Walking performance week-3 and week-6ek Six minute walk test,Metabolic cost week 3 and week 6 oxygen consumption during walking test,Temporal-Spatial Gait Analysis week 3 and week 6 gait parameters measured using G walk sensor system,dynamic balance week 3 and week 6 four square stepped test, Quality of Life week 6 Prosthesis Evaluation Questionnaire Thai version | — |
Secondary
| Measure | Time frame |
|---|---|
| step count week 3 and week 6 pedometer (Dretek Japan,H-235PK),Hip range of motion Week 6 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
Outcome results
None listed