Clinical trial NCT05751408: Technical Evaluation of Commercial IMUs Within Clinical Gait Analysis
Official title: Technical Evaluation of Commercial IMUs Within Clinical Gait Analysis in Adult Patients With Neurological Disorders
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gait Analysis
Lead sponsor: Roessingh Research and Development
Sponsor class: OTHER
First posted: 2023-03-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
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

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Ankle angle assessed by Vicon
timeFrame: baseline
measure: Ankle angle assessed by Vicon
timeFrame: 1 year
measure: Knee angle assessed by Vicon
timeFrame: baseline
measure: Knee angle assessed by Vicon
timeFrame: 1 year
measure: Hip angle assessed by Vicon
timeFrame: baseline
measure: Hip angle assessed by Vicon
timeFrame: 1 year
measure: Ankle angle assessed by IMU sensors
timeFrame: baseline
measure: Ankle angle assessed by IMU sensors
timeFrame: 1 year
measure: Knee angle assessed by IMU sensors
timeFrame: baseline
measure: Knee angle assessed by IMU sensors
timeFrame: 1 year
measure: Hip angle assessed by IMU sensors
timeFrame: baseline
measure: Hip angle assessed by IMU sensors
timeFrame: 1 year
Secondary outcomes:
measure: Age
timeFrame: at inclusion
measure: Height
timeFrame: at inclusion
measure: Weight
timeFrame: at inclusion
measure: FAC-score
timeFrame: at inclusion
Other outcomes:
Locations:
city: Enschede
country: Netherlands
facility: Roessingh Research and Development
Study officials:
affiliation: Roessingh Research and Development
name: C Nikamp, PhD
role: PRINCIPAL_INVESTIGATOR
References: