None listed
Conditions
Interventions
Medical Device : This clinical trial is a comparative study. Once a subject who meets the inclusion and exclusion criteria voluntarily signs the informed consent form by hand, the subject will be enro
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who have undergone transtibial (below-knee) amputation and peripheral nerve interface surgery. 2) Patients weighing between 45 kg and 100 kg. 3) Patients with a K-level of 1 or higher at screening. 4) Patients who use a non-powered (passive) lower-limb prosthesis. 5) Patients aged 19 to 75 years (inclusive).
Exclusion criteria
Exclusion criteria: 1) Patients who weigh less than 45 kg or more than 100 kg. 2) Patients who use a walking aid or assistive device for ambulation. 3) Patients with skin disease at the contact area of the microprocessor-controlled prosthetic limb. 4) Patients with cognitive impairment. 5) Patients with comorbidities or health conditions that may affect the study (e.g., history of stroke, presence of a cardiac pacemaker, severe ischemic heart disease, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gait evaluation and Gait analysis | — |
Secondary
| Measure | Time frame |
|---|---|
| patient satisfaction questionnaire;Electromyography;Appearance and Pain Assessment | — |
Countries
Korea, Republic of
Contacts
Public Contactjoomin Hwang
Asan Medical Center
Outcome results
None listed