Z89.5
Conditions
Interventions
Group 1: Measurement session 1: Fitting and biomechanical investigation with the Ottobock Taleo Low Profile prosthetic foot
Measurement session 2: Fitting and biomechanical investigation with the Blat
Sponsors
Otto Bock France
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Person is at least 18 years old. - Person is a unilateral transtibial amputee with stabilized residual limb. - Person has mobility level corresponding to the code d4608 in the International Classification of Functioning, Disability and Health14 (ability to move around in different environments) - Person has at least 6 months experience in walking with a prosthesis. - Person has a foot size between 22 and 30. - Person weights with a prosthesis between 50 and 125 kg - Person wears a prosthesis daily and = 8 hours/day. - Person is willing and able to independently provide informed consent. - Person is willing to comply with study procedures.
Exclusion criteria
Exclusion criteria: - Person is pregnant. - Person has conditions that would prevent participation and pose increased risk (e.g., unstable car-diovascular conditions that preclude physical activity such as walking). - Person is not available for study visits during planned study duration. - Person is participating in another study or intends to participate in another study during this study’s duration. - Person cannot personally provide their consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of minimum toe clearance (MTC) during level ground walking. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Evaluation of further biomechanical parameters while standing, walking on level ground and ramps, • Evaluation of the socket comfort while using each of the tested feet with the Socket Comfort Score (SCS), • Evaluation of the satisfaction with each of the tested feet with the assistive device part of the Que-bec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) questionnaire. | — |
Countries
Germany
Contacts
Public ContactPawel Maciejasz
Clinical Research & Services, Ottobock SE & Co. KGaA
Outcome results
None listed