Lower Extremity Outcome Measures in SCI

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04032314
• Other study ID #: 2018-01451
• Status: Completed
• Start date: December 1, 2018
• Est. completion date: July 5, 2021

Study information

• Verified date: December 2023
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: July 5, 2021
• Est. primary completion date: July 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries

Locations

Country	Name	City	State
Switzerland	University Hospital Balgrist	Zürich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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).
Primary	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)