Comparative Exploration Clinical Trial of Gait in Conventional Non-powered Thigh Prosthesis and Hip-Knee Combined Smart Robot Lower Limb Prosthesis

Clinical Trial Exploring a Comparative Analysis of Walking between Conventional Non-powered Thigh Prosthesis and Hip-Knee Combined Smart Robot Lower Limb Prosthesis in Femoral Amputees

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0009095

Enrollment

Registered

2024-01-05

Start date

2023-10-17

Completion date

Unknown

Last updated

2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : This clinical trial satisfies the inclusion/exclusion criteria and performs and calculates basic tests and K-Level. K-Level is used as a valid evaluation index for prosthesis in clini

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients who have undergone femoral amputation surgery and/or peripheral nerve interface creation surgery in the last 50 years. 2. Patients with a body weight within the range of 45 kg to 100 kg. 3. Patients with a K-level of 1 or above during screening. 4. Patients using a conventional non-powered thigh prosthesis. 5. Patients aged 19 to 75 years.

Exclusion criteria

Exclusion criteria: Patients with a body weight less than 45 kg or exceeding 100 kg. Patients with skin disorders on the contact area of the robotic prosthesis. Patients with cognitive impairments. Patients with coexisting diseases or health conditions that may impact the research (e.g., stroke, pacemaker placement, severe ischemic heart disease, etc.).

Design outcomes

Primary

Measure	Time frame
Gait evaluation	—

Secondary

Measure	Time frame
pain evaluation	—

Countries

Korea, Republic of

Contacts

Public ContactHyojin Kim

Asan Medical Center

kimhyo41014101@gmail.com+82-2-2045-4291

Outcome results