- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02150629
Investigating Kinematic and Electromyographic Changes After SCI and Their Relation to Clinical and Functional Outcome
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Zurich, Switzerland
- Balgrist University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Healthy subjects
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SCI patients
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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
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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
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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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