Lower Extremity Outcome Measures in SCI

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.

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Balgrist

Zurich, Canton of Zurich, 8008, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Kinematic movement analysis recorded with a motion capture system

Time frame: 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 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
Kinematic movement analysis recorded with a motion capture system

Time frame: 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 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
Kinematic movement analysis recorded with a motion capture system

Time frame: 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 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

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study 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

Important dates

Study start: 2018
Primary completion: 2021
Study completion: 2021
First posted: Jul 25, 2019
Registry last updated: Dec 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed