Lower Extremity Outcome Measures in SCI

Study Overview
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Brief Summary
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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.

Official Title
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Lower Extremity Outcome Measures: A Cross-sectional and Longitudinal Observation of Kinematic, Kinetic and Electromyographic Parameters Focussing on Lower Extremity Function in Spinal Cord Injured Patients

Conditions
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Spinal Cord Injuries

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy controls - cross-sectional project design<br> | |
| Patients - cross-sectional project design<br> | |
| Patients - longitudinal project design<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kinematic movement analysis recorded with a motion capture system | Kinematic movement variables crucial for recovery in lower extremity function after SCI are monitored throughout rehabilitation to generate complex and sensitive profiles of the neurological and functional recovery | Cross-sectional part: one measurement timepoint for patients with chronic SCI within 2 weeks after inclusion (chronic is defined as > 6 months after injury) | 
| Kinematic movement analysis recorded with a motion capture system | Kinematic movement variables crucial for recovery in lower extremity function after SCI are monitored throughout rehabilitation to generate complex and sensitive profiles of the neurological and functional recovery | Longitudinal part: approx. one measurement timepoint per month where outcome measures will be assessed. Starting < 6 weeks after SCI and continued up to 6 months (or end of rehabilitation). | 
| Kinematic movement analysis recorded with a motion capture system | Kinematic movement variables crucial for recovery in lower extremity function after SCI are monitored throughout rehabilitation to generate complex and sensitive profiles of the neurological and functional recovery | Longitudinal part: approx. one measurement timepoint per month where outcome measures will be assessed. Starting < 6 weeks after SCI and continued up to 6 months (or end of rehabilitation) |