Spinal Cord InjuriesNCT04032314
Lower Extremity Outcome Measures in SCI
An observational study of Spinal Cord Injuries, run by University of Zurich at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries
- How many people
- 55 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Dec 2018to 5 Jul 2021
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with an acute or chronic spinal cord injury
Who may be able to join
- 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
Show all 9Show fewer
- Age 18-80
- Written informed consent
- General consent
Who cannot join
- 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
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Balgrist
Zurich, Canton of Zurich, 8008
About this study
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
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.
- Conditions
- Spinal Cord Injuries
- 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 |
|---|---|---|
| Healthy controls - cross-sectional project design | Not described | |
| Patients - cross-sectional project design | Not described | |
| Patients - longitudinal project design | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 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
Measured: 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 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
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2019
- Study start1 Dec 2018
- Primary completion5 Jul 2021
- Study completion5 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 55 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
- NCT04032314
- Sponsor's protocol ID
- 2018-01451
- Other IDs
- 2018
- Status last verified
- Dec 2023
- First submitted
- 13 Nov 2018
- Last updated
- 13 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04032314
- Acronym / sponsor ID
- 2018-01451
- Conditions
- Spinal Cord Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 5 Jul 2021 (actual)
- Study completion
- 5 Jul 2021 (actual)
- First posted
- 25 Jul 2019 (actual)
- 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.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy controls - cross-sectional project design | – | – |
| Patients - cross-sectional project design | – | – |
| Patients - longitudinal project design | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with an acute or chronic spinal cord injury
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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
- Reliance on walking aids / prostheses for mobilisation
- Orthopaedic diagnosis with potential impact on gait
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
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
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 13 Dec 2023.
Related trials for Spinal Cord Injuries
Recruiting
MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System
Paralysis; Quadriplegic, Quadraplegia
Recruiting
Implant for Walking After Incomplete SCI
Spinal Cord Injury (SCI), Gait
Recruiting
tSCS Combined With Rehabilitation Training in Treating Paraplegic Patients After SCI
Spinal Cord Injury, Paraplegia, Spinal
Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
Recruiting
Cuneiform Nucleus (CnF) Deep Brain Stimulation for Gait Facilitation Following Spinal Cord Injury
Spinal Cord Injuries
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 Injuries, 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 9 inclusion and 8 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 13 Dec 2023. 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?
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)). The study lists 3 primary outcomes in all. 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 13 Dec 2023; AzTrials last refreshed its copy on 31 Oct 2026.