Technical Evaluation of Commercial IMUs Within Clinical Gait Analysis

NCT ID: NCT05751408

Last Updated: 2024-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-25

Study Completion Date

2025-06-30

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.

Conditions

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Gait Analysis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Stiff knee gait

Subjects referred to clinical 3D gait analysis because of a clinical question related to stiff knee gait

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

Intervention Type PROCEDURE

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

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

Intervention Type PROCEDURE

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

Interventions

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

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Roessingh Research and Development

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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C Nikamp, PhD

Role: PRINCIPAL_INVESTIGATOR

Roessingh Research and Development

Locations

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Roessingh Research and Development

Enschede, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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C Nikamp, PhD

Role: CONTACT

+31880875777

Facility Contacts

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L Schaake, BSc

Role: primary

+3188087577

Other Identifiers

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2022-16038

Identifier Type: -

Identifier Source: org_study_id

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