Technical Evaluation of Commercial IMUs Within Clinical Gait Analysis

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

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.

Study Overview

• Status: Recruiting
• Conditions: Gait Analysis
• Intervention / Treatment: Procedure: gait analysis using 3D (Vicon) and IMU (Movella)

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.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: C Nikamp, PhD; Phone Number: +31880875777; Email: c.nikamp@rrd.nl

Study Locations

• Netherlands
  • Enschede, Netherlands, 7522AH
    • Recruiting
    • Roessingh Research and Development
    • Contact: L Schaake, BSc; Phone Number: +3188087577; Email: l.schaake@rrd.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects minimum 18 years of age, referred for clinical gait analysis at Roessingh, Centre for Rehabilitation in Enschede, the Netherlands with disorders affecting walking, including amongst others stroke, traumatic brain injury, MS, incomplete spinal cord injury, CP, Spina Bifida, neuromuscular diseases

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Stiff knee gait; Subjects referred to clinical 3D gait analysis because of a clinical question related to stiff knee gait	Procedure: gait analysis using 3D (Vicon) and IMU (Movella); Subjects are measured using Vicon 3D analysis, combined with IMU-sensors
Foot surgery; Subjects referred to clinical 3D gait analysis because of a clinical question related to foot surgery	Procedure: gait analysis using 3D (Vicon) and IMU (Movella); Subjects are measured using Vicon 3D analysis, combined with IMU-sensors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ankle angle assessed by Vicon	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)	baseline
Ankle angle assessed by Vicon	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)	1 year
Knee angle assessed by Vicon	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)	baseline
Knee angle assessed by Vicon	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)	1 year
Hip angle assessed by Vicon	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)	baseline
Hip angle assessed by Vicon	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)	1 year
Ankle angle assessed by IMU sensors	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)	baseline
Ankle angle assessed by IMU sensors	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)	1 year
Knee angle assessed by IMU sensors	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)	baseline
Knee angle assessed by IMU sensors	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)	1 year
Hip angle assessed by IMU sensors	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)	baseline
Hip angle assessed by IMU sensors	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)	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age	Age (in years)	at inclusion
Height	Height (in cm)	at inclusion
Weight	Weight (in kg)	at inclusion
FAC-score	Functional Ambulation Categorie score (0-5 points) to assess independence of walking	at inclusion

Collaborators and Investigators

• Sponsor: Roessingh Research and Development
• Investigators: Principal Investigator: C Nikamp, PhD, Roessingh Research and Development

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2023
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: January 25, 2023
• First Submitted That Met QC Criteria: February 20, 2023
• First Posted (Actual): March 2, 2023

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2022-16038

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No