MedDataX Logo

Lower Extremity Outcome Measures in SCI

NCT ID: NCT04032314

Last Updated: 2023-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-01

Study Completion Date

2021-07-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Spinal Cord Injuries

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Healthy controls - cross-sectional project design

No interventions assigned to this group

Patients - cross-sectional project design

No interventions assigned to this group

Patients - longitudinal project design

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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


* Age 18-80
* Written informed consent
* General consent

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Zurich

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital Balgrist

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2018-01451

Identifier Type: -

Identifier Source: org_study_id