Spinal Cord InjuryNCT02150629
Investigating Kinematic and Electromyographic Changes After SCI and Their Relation to Clinical and Functional Outcome
An observational study of Spinal Cord Injury, run by University of Zurich at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury
- How many people
- 161 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2011to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Spinal cord injury patients and healthy control subjects
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Spinal Cord Injury
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SCI patients | Not described | |
| Healthy subjects | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of gait kinematics after spinal cord injury over one year
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2014 (estimated)
- Study startJan 2011
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02150629
- Sponsor's protocol ID
- KEK-ZH-2011-0257/PB_2016-00228
- Status last verified
- Feb 2021
- First submitted
- 13 May 2014
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Kinematic and Electromyographic Changes After SCI and Their Relation to Clinical and Functional Outcome
- ClinicalTrials.gov ID
- NCT02150629
- Acronym / sponsor ID
- KEK-ZH-2011-0257/PB_2016-00228
- Conditions
- Spinal Cord Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jan 2011 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 30 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCI patients | – | – |
| Healthy subjects | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Spinal cord injury patients and healthy control subjects
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injury, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2021.