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NCT Number: NCT05751408

Technical Evaluation of Commercial IMUs Within Clinical Gait Analysis

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.

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Key information

Conditions

Gait Analysis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Roessingh Research and Development

Enschede, 7522AH, Netherlands

Location status: Recruiting

Location contact

L Schaake, BSc

CONTACT

[email protected]

+3188087577

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

gait analysis using 3D (Vicon) and IMU (Movella)

Procedure

Subjects are measured using Vicon 3D analysis, combined with IMU-sensors

Primary outcomes

  1. Ankle angle assessed by Vicon

    Time frame: baseline

    Vicon 3D analysis will be used to assess ankle angles (in degrees) during walking. Angles will be defined from the moment the foot hits the ground (initial contact) until the foot hits the ground again (second initial contact)

  2. Ankle angle assessed by Vicon

    Time frame: 1 year

    Vicon 3D analysis will be used to assess ankle angles (in degrees) during walking. Angles will be defined from the moment the foot hits the ground (initial contact) until the foot hits the ground again (second initial contact)

  3. Knee angle assessed by Vicon

    Time frame: baseline

    Vicon 3D analysis will be used to assess knee angles (in degrees) during walking. Angles will be defined from the moment the foot hits the ground (initial contact) until the foot hits the ground again (second initial contact)

  4. Knee angle assessed by Vicon

    Time frame: 1 year

    Vicon 3D analysis will be used to assess knee angles (in degrees) during walking. Angles will be defined from the moment the foot hits the ground (initial contact) until the foot hits the ground again (second initial contact)

  5. Hip angle assessed by Vicon

    Time frame: baseline

    Vicon 3D analysis will be used to assess hip angles (in degrees) during walking. Angles will be defined from the moment the foot hits the ground (initial contact) until the foot hits the ground again (second initial contact)

  6. Hip angle assessed by Vicon

    Time frame: 1 year

    Vicon 3D analysis will be used to assess hip angles (in degrees) during walking. Angles will be defined from the moment the foot hits the ground (initial contact) until the foot hits the ground again (second initial contact)

  7. Ankle angle assessed by IMU sensors

    Time frame: baseline

    IMU sensors will be used to assess ankle angles (in degrees) during walking. Angles will be defined from the moment the foot hits the ground (initial contact) until the foot hits the ground again (second initial contact)

  8. Ankle angle assessed by IMU sensors

    Time frame: 1 year

    IMU sensors will be used to assess ankle angles (in degrees) during walking. Angles will be defined from the moment the foot hits the ground (initial contact) until the foot hits the ground again (second initial contact)

  9. Knee angle assessed by IMU sensors

    Time frame: baseline

    IMU sensors will be used to assess knee angles (in degrees) during walking. Angles will be defined from the moment the foot hits the ground (initial contact) until the foot hits the ground again (second initial contact)

  10. Knee angle assessed by IMU sensors

    Time frame: 1 year

    IMU sensors will be used to assess knee angles (in degrees) during walking. Angles will be defined from the moment the foot hits the ground (initial contact) until the foot hits the ground again (second initial contact)

  11. Hip angle assessed by IMU sensors

    Time frame: baseline

    IMU sensors will be used to assess knee angles (in degrees) during walking. Angles will be defined from the moment the foot hits the ground (initial contact) until the foot hits the ground again (second initial contact)

  12. Hip angle assessed by IMU sensors

    Time frame: 1 year

    IMU sensors will be used to assess knee angles (in degrees) during walking. Angles will be defined from the moment the foot hits the ground (initial contact) until the foot hits the ground again (second initial contact)

Secondary outcomes

  1. Age

    Time frame: at inclusion

    Age (in years)

  2. Height

    Time frame: at inclusion

    Height (in cm)

  3. Weight

    Time frame: at inclusion

    Weight (in kg)

  4. FAC-score

    Time frame: at inclusion

    Functional Ambulation Categorie score (0-5 points) to assess independence of walking

Study contacts

Contact information is provided by the study sponsor or research team.

C Nikamp, PhD

CONTACT

[email protected]

+31880875777

Sponsors and collaborators

Lead sponsor

Roessingh Research and Development

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Mar 2, 2023
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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