Lower Extremity Outcome Measures in SCI

University of Zurich (UZH)

Status: Completed

Conditions: Spinal Cord Injuries

Study type: Observational

Funder types: Other

Identifiers

NCT04032314

2018-01451

Details and patient eligibility

About

Lower extremity (LE) function of patients with a spinal cord injury (SCI) will be assessed in an observational project with a cross-sectional and a longitudinal study design. The main goal is to identify kinematic and kinetic parameters to precisely characterize LE function and in parallel the impairment and limitation in SCI patients throughout rehabilitation in acute patients and in chronic patients to define LE function and LE recovery.

Enrollment: 55 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria - Patients:

• Age 18-80
• Written informed consent
• General consent
• Spinal cord injury (SCI)
• ASIA A-D injury with lowest extent of lesion between C1 and Th12
• Mini-Mental stat examintation score > 26

Exclusion Criteria - Patients:

• Inability to undertake any component of the trial protocol
• Clinically significant conditions such as severe cardiovascular, pulmonary or malignant disease
• Pure cauda equina i.e. peripheral nerve injury

Inclusion Criteria - Healthy controls:

• Age 18-80
• Written informed consent
• General consent

Exclusion Criteria - Healthy controls:

• Reliance on walking aids / prostheses for mobilisation
• Orthopaedic diagnosis with potential impact on gait
• Previous operations on the lower limbs or spine with potential impact on gait
• Inabilitay to undertake any component of the trial protocol
• Clinically significant conditions such as severe cardiovascular, pulmonary or malignant disease

Trial design

55 participants in 3 patient groups

Healthy controls - cross-sectional project design

Patients - cross-sectional project design

Patients - longitudinal project design