Investigating Kinematic and Electromyographic Changes After SCI and Their Relation to Clinical and Functional Outcome

February 15, 2021 updated by: University of Zurich
The study aims at discerning specific gait patterns and elucidating locomotor control of spinal cord injured patients in order to find sensitive kinematic and electromyographic outcome measures that are able to reveal information on underlying mechanisms of normal and aberrant gait control and its recovery over time. These measures may also be used to compare the outcome across different neurological disorders.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

161

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland
        • Balgrist University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Spinal cord injury patients and healthy control subjects

Description

Inclusion Criteria:

Patients: We will monitor patients who were admitted to the Spinal Cord Injury Center of the University Hospital Balgrist. We will record patients with various aetiologies, grades of impairment and types of spinal cord lesions. Patients need to have minimal voluntary motor capacities: the motor scores of the key muscles according to the ASIA classification (www.asia-spinalinjury.org) should be at least 3 for extensor muscles and 2 for flexor muscles. Written informed consent is required. Control subjects: Healthy subjects, written informed consent.

Exclusion Criteria:

Patients: Comorbidities which influence or inhibit gait or upper-limb motion (e.g. peripheral nerve lesions). Orthostatic problems that greatly impair upright body position. Mental illness, cognitive impairments. Control subjects: neurologic disease, walking disabilities, mental illness, cognitive impairments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Healthy subjects
SCI patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of gait kinematics after spinal cord injury over one year
Time Frame: 1) very acute: 0 - 14 days after injury; 2) acute I: 2 - 4 weeks post-injury; 3) acute II: 4 - 12 weeks post-injury; 4) acute III: 12 - 24 weeks post-injury; 5) chronic: 24 - 48 weeks post-injury
1) very acute: 0 - 14 days after injury; 2) acute I: 2 - 4 weeks post-injury; 3) acute II: 4 - 12 weeks post-injury; 4) acute III: 12 - 24 weeks post-injury; 5) chronic: 24 - 48 weeks post-injury

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2011

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

May 13, 2014

First Submitted That Met QC Criteria

May 27, 2014

First Posted (Estimate)

May 30, 2014

Study Record Updates

Last Update Posted (Actual)

February 16, 2021

Last Update Submitted That Met QC Criteria

February 15, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEK-ZH-2011-0257/PB_2016-00228

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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