Technical Evaluation of Commercial IMUs Within Clinical Gait Analysis
ConditionGait Analysis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRoessingh Research and Development
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial 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
Trial design
Design model
Other
Time perspective
Other
Treatments tested in this trial
gait analysis using 3D (Vicon) and IMU (Movella)
Procedure/SurgerySubjects are measured using Vicon 3D analysis, combined with IMU-sensors
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Stiff knee gait1 intervention
Group B: Foot surgery1 intervention
Trial outcomes
Primary outcomes
1
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)
Time frame
baseline2
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)
Time frame
1 year3
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)
Time frame
baseline4
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)
Time frame
1 yearSecondary outcomes
1
Age
Age (in years)
Time frame
at inclusion2
Height
Height (in cm)
Time frame
at inclusion3
Weight
Weight (in kg)
Time frame
at inclusion4
FAC-score
Functional Ambulation Categorie score (0-5 points) to assess independence of walking
Time frame
at inclusionSponsors and contacts
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Source ClinicalTrials.gov