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The effect of gait assistance by a wearable robotic orthosis in patients with complete paraplegia due to spinal cord injury

The effect of gait assistance by a wearable robotic orthosis in patients with complete paraplegia due to spinal cord injury

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0004395
Enrollment
10
Registered
2019-10-29
Start date
2019-07-02
Completion date
Unknown
Last updated
2019-11-05

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 : After conducting a preliminary basic assessment, the existing rehabilitation treatment is continued with preparation period of 8-12 weeks, and basic physical training and wearable rob

Sponsors

Korea Evaluation Institute of Industrial Technology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: ? Age over 19 ? 6 months or more from onset ? Those who are unable to stand and walk independently due to complete motor paralysis (ASIA-A or B) at neurological level of T9 – Lumbar.

Exclusion criteria

Exclusion criteria: ? When cognitive function is deteriorated and it is impossible to determine participation in research independently or to participate in evaluation ? Patients who cannot read the consent form or whose written consent is impossible ? Patients with severe lower extremity joint construction or fracture (Hip joint> 30 degrees, Knee joint> 30 degrees) ? Patients with severe osteoporosis (BMD (t = -3.5) and / or 0.60g / cm2) ? Patients undergoing orthopedic surgery in the lower extremities within 6 months of training ? Patients with cardiovascular abnormalities or venous thrombosis ? Those who have skin abnormalities that limit the wearing of braces. ? Other subjects deemed unsuitable for this study

Design outcomes

Primary

MeasureTime frame
oxygen consumption (mL/kg.min), oxygen cost (mL/kg.meter), 6 minute walking test

Secondary

MeasureTime frame
SCIM-III(Spinal Cord Independence Measure-III), WISCI-II(Walking Index of Spinal Cord Injury-II), Vital Capacity

Countries

Korea, Republic of

Contacts

Public ContactJusun Kim

Yonsei University Health System, Severance Hospital

Outcome results

None listed

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