Investigation of Gait Parameters in Health and Neurologic... | NCT02165787

Studies
Investigation of Gait Parameters in Health and Neurological Disease Under Varying Locomotor Conditions

NCT02165787

Sponsor

University of Zurich

Status

Completed

Last Update Posted

Sep 22, 2025Actual

Enrollment

208Actual

Phase

Not provided

Conditions

Gait Analysis in Neurological Disorders

Interventions

Not provided

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2014

Primary Completion Date

Dec 2019Actual

Completion Date

Dec 10, 2019Actual

First Submitted Date

May 23, 2014

First Submission Date that Met QC Criteria

Jun 13, 2014

First Posted Date

Jun 17, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 16, 2025

Last Update Posted Date

Sep 22, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

208Actual

Measure	Description	Time Frame
Change of gait parameter after injury to CNS		Timepoint 0 plus timepoint 6 months and 12 months

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Adult patients aged 18-80 with spinal cord injury, hemispheric stroke, multiple sclerosis, Parkinson disease, vestibular disease, cerebellar disease. Healthy control subjects aged 18-80.

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
University of Zurich		Zurich	Canton of Zurich	8008	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27574966	Background	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.
28280596	Background	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.