- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07236008
Training and Testing Database for IMU Based Gait Analysis Methods (IMU-GAIT)
The goal of this study is to establish a high-quality, synchronised dataset of gait events (GE) by simultaneously collecting inertial measurement unit (IMU) data and validated ground truth detections using a Vicon motion capture system. The primary objective is to address existing limitations in GE detection - such as poor generalisability, limited data diversity, and lack of precise synchronisation - through a rigorous protocol that ensures accuracy and transparency. The experiment is structured in three phases. First, Vicon-derived GE will be validated and refined using complementary modalities (force plates and video recordings). Next, deep learning (DL) algorithms will be developed and evaluated for GE detection directly from IMU data, with Vicon annotations serving as ground truth. Finally, the impact of differences in GE timing on spatiotemporal gait parameters (SGP) will be analysed to assess the feasibility of using IMU-only systems for reliable gait analysis.
By achieving these objectives, the study aims to improve the accuracy of GE detection from wearable sensors and enable more accessible, scalable, and reliable gait analysis outside the laboratory environment.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Redona Brahimetaj, Doctor of Engineering Sciences
- Phone Number: 0032465597448
- Email: redona.brahimetaj@vub.be
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Healthy subjects with no motor impairments that disrupt the walking pattern.
- No history of pain in the lower limbs in the past 6 months.
- No history of lower limbs injuries/surgeries in the past 6 months.
- Language: Dutch and/or English and/or French speakers.
- Age 18-65 years old
- Subjects must be able to understand the instructions and to answer questions. Additionally, they should be able to; signal pain, fear, discomfort; give inform consent.
Exclusion Criteria:
- Persons with comorbidity that could hinder the study (e.g.: unstable cardiovascular system disorders, lung disorders, severe osteoporosis).
- Individuals with metal implants or skin conditions that would make sensor or marker placement difficult.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Healthy subjects
Age 18-65 years old
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heel-Strike Timing Error: Force Plates vs Vicon
Time Frame: 4 years
|
Absolute time difference between heel-strike detected by synchronized force plates (reference) and heel-strike detected by the Vicon motion-capture system. Force-plate heel-strike is defined as the first frame with vertical ground-reaction force. Vicon heel-strike is the kinematic event labeled "heel-strike" per the lab's standard pipeline. Error is computed per step, then summarised as overall mean ± SD across participant(s). Lower values indicate better agreement. Unit of Measure: milliseconds (ms) |
4 years
|
|
Toe-Off Timing Error: Force Plates vs Vicon
Time Frame: 4 years
|
Absolute time difference between toe-off from force plates and toe-off detected by Vicon. Error is computed per step, averaged within participant, then summarized as overall mean ± SD. Lower values indicate better agreement. Unit of Measure: milliseconds (ms) |
4 years
|
|
Event Agreement (%): Vicon vs Video - Heel-Strike
Time Frame: 4 years
|
Percentage of heel-strike events for which Vicon and frame-by-frame video annotation indicate the same event within ms tolerance window (several tolerance windows will be explored). Agreement is computed per participant and summarized as mean ± SD across participant(s). Higher values indicate better agreement. Unit of Measure: percent (%) |
4 years
|
|
Event Agreement (%): Vicon vs Video - Toe-Off
Time Frame: 4 years
|
Percentage of toe-off events for which Vicon and video annotation match within a tolerance window (several tolerance windows will be assessed). Computed per participant; summarized as mean ± SD per participant(s). Higher values indicate better agreement. Unit of Measure: percent (%) |
4 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
IMU Heel-Strike Detection Accuracy
Time Frame: 4 years
|
Proportion of correctly classified heel-strike events by the IMU-based deep learning model relative to Vicon ground truth (correct classifications / total events), computed per participant and summarized as mean ± SD across participant(s). Reference & tolerance: Vicon event labels; a match is counted when IMU and Vicon events fall within same detection frame or within a tolerance window we will evaluate. Unit of Measure: percent (%) |
4 years
|
|
Step Time Accuracy
Time Frame: 4 years
|
Description: Absolute difference in step time between IMU-derived and Vicon-derived gait event detection. Step time is defined as the time between consecutive heel-strikes of opposite feet. Unit of Measure: milliseconds (ms) |
4 years
|
|
IMU Toe-Off Detection Accuracy
Time Frame: 4 years
|
Proportion of correctly classified toe off events by the IMU-based deep learning model relative to Vicon ground truth (correct classifications / total events), computed per participant and summarized as mean ± SD across participant(s). Reference & tolerance: Vicon event labels; a match is counted when IMU and Vicon events fall within same detection frame or within a tolerance window we will evaluate. Unit of Measure: percent (%) |
4 years
|
|
IMU Heel-Strike Sensitivity (Recall)
Time Frame: 4
|
True positives / (true positives + false negatives) for heel-strike detection vs Vicon, computed per participant(s); summarized as mean ± SD. Higher is better. Unit of Measure: percent (%) Reference & tolerance: Vicon labels; match within a tolerance window to be analysed |
4
|
|
IMU Heel-Strike Specificity
Time Frame: 4 years
|
True negatives / (true negatives + false positives) for heel-strike detection vs Vicon, computed per participant(s); summarized as mean ± SD. Higher is better. Reference & tolerance: Vicon labels; match within a tolerance window to be analysed Unit of Measure: percent (%) |
4 years
|
|
IMU Toe-Off Sensitivity (Recall)
Time Frame: 4 years
|
TP / (TP + FN) for toe-off detection vs Vicon, computed per participant(s); summarized as mean ± SD. Higher is better. Reference & tolerance: Vicon labels; match within a tolerance window to be analysed Unit of Measure: percent (%) Time Frame: 4 years |
4 years
|
|
IMU Toe-Off Specificity
Time Frame: 4 years
|
TN / (TN + FP) for toe-off detection vs Vicon, computed per participant(s); summarized as mean ± SD. Higher is better. Reference & tolerance: Vicon labels; match within a tolerance window to be analysed Unit of Measure: percent (%) Time Frame: 4 years |
4 years
|
|
Cadence Accuracy
Time Frame: 4 years
|
Description: Absolute difference in cadence between IMU-derived and Vicon-derived measurements. Cadence is defined as the number of steps per minute. Unit of Measure: steps per minute (steps/min) |
4 years
|
|
Step Length Accuracy
Time Frame: 4 years
|
Description: Absolute difference in step length between IMU-derived and Vicon-derived measurements. Step length is defined as the distance between heel-strikes of opposite feet. Unit of Measure: meters (mm) |
4 years
|
|
Step-Time Asymmetry Accuracy
Time Frame: 4 years
|
Description: Absolute difference in step-time asymmetry index between IMU-derived and Vicon-derived data. The asymmetry index is calculated as the relative difference between left and right step times. Unit of Measure: percent (%) |
4 years
|
|
Stride Time Accuracy
Time Frame: 4 years
|
Description: Absolute difference in stride time between IMU-derived and Vicon-derived data. Stride time is defined as the time between heel-strikes of the same foot. Unit of Measure: milliseconds (ms) |
4 years
|
|
Stride Length Accuracy
Time Frame: 4 years
|
Description: Absolute difference in stride length between IMU-derived and Vicon-derived measurements. Stride length is defined as the distance between consecutive heel-strikes of the same foot. Unit of Measure: meters (mm) |
4 years
|
|
Stance Time Accuracy
Time Frame: 4 years
|
Description: Absolute difference in stance time between IMU-derived and Vicon-derived data. Stance time is defined as the time from heel-strike to toe-off of the same foot. Unit of Measure: milliseconds (ms) |
4 years
|
|
Double-Support Time Accuracy
Time Frame: 4 years
|
Description: Absolute difference in double-support time between IMU-derived and Vicon-derived measurements. Double-support time refers to the duration during which both feet are in contact with the ground. Unit of Measure: milliseconds (ms) |
4 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight
Time Frame: 4 years
|
Body weight will be measured using a calibrated digital scale, with participants wearing light clothing and no shoes. Weight will be recorded once at baseline and at scheduled follow-ups. Results will be summarized as mean ± standard deviation across participants. Unit of Measure: kilograms (kg) |
4 years
|
|
Height
Time Frame: 4 years
|
Standing height will be measured using a wall-mounted stadiometer, with participants standing upright, without shoes, and heels together. Results will be summarized as mean ± standard deviation across participants. Unit of Measure: meters (mm) |
4 years
|
|
Body Mass Index (BMI)
Time Frame: 4 years
|
BMI will be calculated as weight (kg) divided by height squared (m²). This provides a standardized measure of relative weight adjusted for height. Results will be summarized as mean ± standard deviation across participants. Unit of Measure: kilograms per square meter (kg/m²) |
4 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 25235_IMU-GAIT
- 25235 (Registry Identifier: 25235)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy Subjects or Volunteers
-
University of Novi SadNot yet recruitingHealthy Subjects or Volunteers
-
Poitiers University HospitalCompletedCerebrospinal Fluid | Healthy Subjects or VolunteersFrance
-
Pusan National University Yangsan HospitalRecruitingHealthy Subjects/VolunteersSouth Korea
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
University of Vermont Medical CenterAvocado Nutrition CenterRecruitingHealthy | Healthy Volunteers | Healthy Subjects | Healthy Volunteer | Healthy Adult | Healthy Volunteers Only | Healthy Male and Female Subjects | Healthy Non-smokersUnited States
-
The Methodist Hospital Research InstituteRecruitingHealthy | Healthy Volunteers | Healthy Male and Female SubjectsUnited States
-
University of PalermoCompletedHealthy | Healthy Volunteers | Healthy Subjects | Healthy Participants | Static Stretching | Stretch | StretchingItaly
-
AbbottCompletedHealthy Subjects | Healthy Participants | Bioequivalence | Human VolunteersIndia
-
University of Rhode IslandCompletedHealthy Subjects or Volunteers | People With Identified Painful Trigger Points (Tp) Within the Soleus and Gastrocnemius Muscles ComplexUnited States
-
MedImmune LLCCompletedAsthma | Healthy Subjects or VolunteersUnited States