CompletedNot Applicable

Lower Extremity Outcome Measures in SCI

Switzerland55 participantsStarted 2018-12-01

Plain-language 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 limitation in SCI patients throughout rehabilitation in acute patients and in chronic patients to define LE function and LE recovery.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Kinematic movement analysis recorded with a motion capture system

Timeframe: 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

Timeframe: 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

Timeframe: 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)

Trial details

NCT IDNCT04032314

SponsorUniversity of Zurich

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-07-05

View on ClinicalTrials.gov More Spinal Cord Injuries trials

Plain-language summary

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Kinematic movement analysis recorded with a motion capture system

Timeframe: 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

Timeframe: 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)