Technical Evaluation of Commercial IMUs Within Clinical Gait Analysis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Gait Analysis

Intervention / Treatment
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* Procedure: gait analysis using 3D (Vicon) and IMU (Movella)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Stiff knee gait<br>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)<br>* Subjects are measured using Vicon 3D analysis, combined with IMU-sensors<br>|
| Foot surgery<br>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)<br>* Subjects are measured using Vicon 3D analysis, combined with IMU-sensors<br>|

What is the study measuring?
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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 |