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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02165787
Other study ID # KEK-ZH-2014-0004/PB_2016-00386
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 2014
Est. completion date March 2025

Study information

Verified date May 2023
Source University of Zurich
Contact Marc Bolliger, PD
Phone +41 44 510 72 01
Email marc.bolliger@balgrist.ch
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In the cross-sectional component of this study, our overall objective is to gather a large pool of data from which we can generate gait "profiles". These profiles will consist of a constellation of gait (+/- electrophysiological) parameters associated with a particular neurological diagnosis or specific lesion(s) in neuroanatomical systems. Once developed, these profiles can be compared for differences and similarities; allowing insights into the specificity of the effect on gait of a given diagnosis or lesion in the case of the former and redundancy of neuroanatomical systems in that of the latter. A longitudinal component of the study will look at the evolution of gait parameters over time in a group of patients with spinal cord injury.


Recruitment information / eligibility

Status Recruiting
Enrollment 340
Est. completion date March 2025
Est. primary completion date March 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: Patients: - age 18 - 80 - written, informed consent - one of the following established diagnoses: unilateral stroke affecting motor system, Parkinson syndrome, cerebellar disease, vestibular dysfunction, spinal cord injury, multiple sclerosis - Brain and whole spine T1, T2 & FLAIR magnetic resonance imaging performed within the last four months and available for study purposes or no contraindications to performing these scans Healthy subjects: - age 18 - 80 - written informed consent Exclusion Criteria: Patients: - Colour-blindness - Known to be pregnant or breastfeeding - Body mass index (weight in kg/height in metres squared) >40 Unable to walk 50m within 6 minutes (with or without walking aids) Inability to undertake any component of the trial protocol - Terminal diagnosis with life expectancy less than six months - Cognitive disturbance defined as MMSE < 25 Clinically significant comorbidities such as severe cardiovascular, pulmonary or malignant disease Healthy subjects: - Colour-blindness - Known to be pregnant or breastfeeding - Body mass index (weight in kg/height in metres squared) >40 Unable to walk 50m within 6 minutes - Reliance on walking aids / prostheses for mobilisation - Significant neurological or orthopaedic diagnosis with potential impact on gait // Previous operations on the lower limbs or spine with potential impact on gait Inability to undertake any component of the trial protocol Clinically significant conditions such as severe cardiovascular, pulmonary or malignant disease

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Switzerland University of Zurich Zurich

Sponsors (1)

Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (4)

Filli L, Meyer C, Killeen T, Lorincz L, Gopfert B, Linnebank M, von Tscharner V, Curt A, Bolliger M, Zorner B. Probing Corticospinal Control During Different Locomotor Tasks Using Detailed Time-Frequency Analysis of Electromyograms. Front Neurol. 2019 Jan 29;10:17. doi: 10.3389/fneur.2019.00017. eCollection 2019. — View Citation

Killeen T, Easthope CS, Demko L, Filli L, Lorincz L, Linnebank M, Curt A, Zorner B, Bolliger M. Minimum toe clearance: probing the neural control of locomotion. Sci Rep. 2017 May 15;7(1):1922. doi: 10.1038/s41598-017-02189-y. — View Citation

Killeen T, Easthope CS, Filli L, Linnebank M, Curt A, Bolliger M, Zorner B. Modulating Arm Swing Symmetry with Cognitive Load: A Window on Rhythmic Spinal Locomotor Networks in Humans? J Neurotrauma. 2017 May 15;34(10):1897-1902. doi: 10.1089/neu.2016.4554. Epub 2016 Oct 12. — View Citation

Killeen T, Easthope CS, Filli L, Lorincz L, Schrafl-Altermatt M, Brugger P, Linnebank M, Curt A, Zorner B, Bolliger M. Increasing cognitive load attenuates right arm swing in healthy human walking. R Soc Open Sci. 2017 Jan 25;4(1):160993. doi: 10.1098/rsos.160993. eCollection 2017 Jan. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change of gait parameter after injury to CNS Timepoint 0 plus timepoint 6 months and 12 months