Technical Evaluation of Commercial IMUs Within Clinical Gait Analysis

• Sponsor: Roessingh Research and Development (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05751408
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Anticipated Duration (Months): 10.2
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Gait Analysis	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 Design

• Study Type: Observational
• Anticipated Enrollment: 20 participants
• Observational Model: Other
• Time Perspective: Other
• Official Title: Technical Evaluation of Commercial IMUs Within Clinical Gait Analysis in Adult Patients With Neurological Disorders
• Actual Study Start Date: Jan 25, 2023
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Ankle angle assessed by Vicon [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 Outcome Measures

1. Age [at inclusion]

   Age (in years)

2. Height [at inclusion]

   Height (in cm)

3. Weight [at inclusion]

   Weight (in kg)

4. FAC-score [at inclusion]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Roessingh Research and Development	Enschede		Netherlands	7522AH

Sponsors and Collaborators

• Roessingh Research and Development

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Roessingh Research and Development
• ClinicalTrials.gov Identifier: NCT05751408
• Other Study ID Numbers: 2022-16038
• First Posted: Mar 2, 2023
• Last Update Posted: Mar 2, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Mar 2, 2023