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Exploratory clinical trial comparing the gait of amputees with below-knee prosthetics and an AI-based robotic lower limb prosthesis

Exploratory clinical trial comparing the gait between existing non-powered lower limb prostheses and AI-based robotic lower limb prostheses that detect gait intention in below-knee amputees

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0010375
Enrollment
6
Registered
2025-04-02
Start date
2024-10-15
Completion date
Unknown
Last updated
2025-05-07

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

Conditions

None listed

Interventions

None listed

Sponsors

Asan Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. All patients who have undergone either a below-knee amputation surgery only or both a below-knee amputation surgery and a peripheral nerve interface 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: 1. Patients whose weight is less than 45kg or more than 100kg 2. Patients who use walking assistive devices 3. Patients with skin conditions at the contact area of robotic prosthetics 4. Patients with cognitive impairments 5. Patients with comorbid diseases or health conditions that may affect the study (e.g., stroke, pacemaker placement, severe ischemic heart disease, etc.) 6. Patients with visual impairments who are unable to participate in virtual reality limb rehabilitation units

Design outcomes

Primary

MeasureTime frame
Electromyography (EMG) Test, Gait evaluation

Secondary

MeasureTime frame
Appearance Assessment, Pain evaluation

Countries

Korea, Republic of

Contacts

Public ContactKim Hyojin

Asan Medical Center

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

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026