Training and Testing Database for IMU Based Gait Analysis Methods

NCT07236008 | Not Yet Recruiting

• 2 other identifiers: 25235_IMU-GAIT25235
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Healthy Subjects or Volunteers

Keywords

Gait analysis; Gait events; Spatiotemporal gait parameters (SGP); Inertial measurement units (IMU); Wearable sensors; Motion capture (Vicon); Deep learning; Machine learning; Healthy adults

Outcome Measures

Primary Outcomes (4)

• Heel-Strike Timing Error: Force Plates vs Vicon

  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

  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

  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

  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 Outcomes (14)

• IMU Heel-Strike Detection Accuracy

  4 years

• Step Time Accuracy

  4 years

• IMU Toe-Off Detection Accuracy

  4 years

• IMU Heel-Strike Sensitivity (Recall)

  4

• IMU Heel-Strike Specificity

  4 years

Other Outcomes (3)

• Weight

  4 years

• Height

  4 years

• Body Mass Index (BMI)

  4 years

Study Arms (1)

Healthy subjects

Age 18-65 years old

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy Adults, age 18-65

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead

Central Study Contacts

Redona Brahimetaj, Doctor of Engineering Sciences

CONTACT

0032465597448; redona.brahimetaj@vub.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr.

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: November 19, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): November 30, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: November 19, 2025

Record last verified: 2025-10