Technical Evaluation of Commercial IMUs Within Clinical Gait Analysis

Gait Analysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05751408
• Other study ID #: 2022-16038
• Status: Recruiting
• Start date: January 25, 2023
• Est. completion date: June 2025

Study information

• Verified date: April 2024
• Source: Roessingh Research and Development
• Contact: C Nikamp, PhD
• Phone: +31880875777
• Email: c.nikamp[@]rrd.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gait Analysis

Intervention

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

Locations

Country	Name	City	State
Netherlands	Roessingh Research and Development	Enschede

Sponsors (1)

Lead Sponsor	Collaborator
Roessingh Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Age	Age (in years)	at inclusion
Secondary	Height	Height (in cm)	at inclusion
Secondary	Weight	Weight (in kg)	at inclusion
Secondary	FAC-score	Functional Ambulation Categorie score (0-5 points) to assess independence of walking	at inclusion