Lower Extremity Outcome Measures in SCI

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

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.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injuries

• Study Type: Observational
• Enrollment (Actual): 55

Contacts and Locations

Study Locations

• Switzerland
  • Zurich
    • Zürich, Zurich, Switzerland, 8008
      • University Hospital Balgrist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients with an acute or chronic spinal cord injury

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Healthy controls - cross-sectional project design
Patients - cross-sectional project design
Patients - longitudinal project design

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University of Zurich

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): July 5, 2021
• Study Completion (Actual): July 5, 2021

Study Registration Dates

• First Submitted: November 13, 2018
• First Submitted That Met QC Criteria: July 24, 2019
• First Posted (Actual): July 25, 2019

Study Record Updates

• Last Update Posted (Estimated): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: 2018-01451

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No