NCT04032314

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2018

Completed
18 days until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
8 months until next milestone

First Posted

Study publicly available on registry

July 25, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2021

Completed
Last Updated

December 13, 2023

Status Verified

December 1, 2023

Enrollment Period

2.6 years

First QC Date

November 13, 2018

Last Update Submit

December 12, 2023

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (3)

  • 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

    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

    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

    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)

Study Arms (3)

Healthy controls - cross-sectional project design

Patients - cross-sectional project design

Patients - longitudinal project design

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with an acute or chronic spinal cord injury

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Balgrist

Zurich, Canton of Zurich, 8008, Switzerland

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2018

First Posted

July 25, 2019

Study Start

December 1, 2018

Primary Completion

July 5, 2021

Study Completion

July 5, 2021

Last Updated

December 13, 2023

Record last verified: 2023-12

Locations

CH(1)