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Recruiting NCT05751408

Technical Evaluation of Commercial IMUs Within Clinical Gait Analysis

Observational Gait Analysis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: gait analysis using 3D (Vicon) and IMU (Movella).
Who it may be relevant to
Registry conditions: Gait Analysis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Technical Evaluation of Commercial IMUs Within Clinical Gait Analysis in Adult Patients With Neurological Disorders

Overview

A standard clinical gait analysis consists of observing walking with video (2D) or advanced equipment (VICON 3D). This 3D method provides detailed information about the gait pattern, but is time-consuming in implementation and data analysis. There are commercial 3D systems on the market that are used in healthy individuals and in sports. These so-called Inertial Measurement Units (IMUs) may also be suitable for use in the clinic. In this research protocol, the aim is to test the usability of commercial sensors and technically compare them with standard clinical 3D gait analysis in adult patients with a neurological disorder.

Detailed description

Measurements will include subjects that perform routine clinical 3D gait analysis because of a clinical question related to stiff knee gait or surgical intervention of the foot. During routine clinical gait analysis, Vicon markers and EMG-measurements of specified muscles is included. IMU-sensors will be included to this routine measurements to measure accelorometer, gyroscope and magnetometer data of both feet, both upper and lower legs, the sternum and the sacrum.

Interventions

  • Procedure gait analysis using 3D (Vicon) and IMU (Movella)
    Subjects are measured using Vicon 3D analysis, combined with IMU-sensors

Primary outcome measures

  • Ankle angle assessed by Vicon [Time frame: baseline]
  • Ankle angle assessed by Vicon [Time frame: 1 year]
  • Knee angle assessed by Vicon [Time frame: baseline]
  • Knee angle assessed by Vicon [Time frame: 1 year]
  • Hip angle assessed by Vicon [Time frame: baseline]
  • Hip angle assessed by Vicon [Time frame: 1 year]
  • Ankle angle assessed by IMU sensors [Time frame: baseline]
  • Ankle angle assessed by IMU sensors [Time frame: 1 year]
  • Knee angle assessed by IMU sensors [Time frame: baseline]
  • Knee angle assessed by IMU sensors [Time frame: 1 year]
Secondary outcome measures (4)
  • Age [Time frame: at inclusion]
  • Height [Time frame: at inclusion]
  • Weight [Time frame: at inclusion]
  • FAC-score [Time frame: at inclusion]

Eligibility criteria

Subjects referred for clinical gait analysis at Roessingh Centre for Rehabilition in Enschede, the Netherlands:

Inclusion criteria

  • Disorders affecting walking, including amongst others stroke, traumatic brain injury, MS, incomplete spinal cord injury, CP, Spina Bifida, neuromuscular diseases
  • age minimum 18 years
  • Viosca score minimum 2; meaning minimal independent walking ability indoors
  • increased fall risk or increased effort of walking because of: 1) decreased stability during stance; and/or 2) decreased foot clearance during swing; and/or 3) not able to walk on bare feet because of equinovarus; and/or 4) fatigue during walking because of compansatory strategies.

Exclusion criteria

  • subjects referred for clinical gait analysis because of problems other than stiff knee gait or foot surgery
  • severe deficits in communication, memory and understanding at such a level that it would affect instructions during the measurements

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Netherlands · 1 center
  • Roessingh Research and Development — Enschede

Identifiers

NCT: NCT05751408 · 2022-16038

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗