NCT07003087

Brief Summary

Artificial intelligence (AI) technology makes gait analysis based on two-dimensional images feasible. The first aim of this study is to develop an analysis platform that uses two-dimensional image analysis technology to determine the relative excursion of body segments and limbs in gait. The second aim is to apply this analysis platform to develop an artificial intelligence model for customized shoe adjustment to optimize gait. For the methodology, OpenPose will be used as the analysis tool to quantify the relative shifts between specific joint/node trajectories of the body, and the VICON three-dimensional motion analysis system will be used to verify the acquisition parameters. For the second aim, an existing 2D gait image database before customized shoe adjustment will be used to obtain the inputs to the customized shoe adjustment AI model. Through training the AI model, enabling to generate the outputs of the most appropriate adjustment parameters for shoe soles. After the AI model has well-trained, the walking kinematics and foot pressure before and after wearing ordinary sports shoes or customized shoes will be compared during running on a treadmill. This research is expected to establish an efficient customized shoe adjustment AI model, allowing users to improve walking efficiency.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
4mo left

Started Aug 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress85%
Aug 2024Aug 2026

Study Start

First participant enrolled

August 5, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 4, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2026

Last Updated

June 4, 2025

Status Verified

February 1, 2025

Enrollment Period

2 years

First QC Date

February 26, 2025

Last Update Submit

June 3, 2025

Conditions

Keywords

gait asymmetry

Outcome Measures

Primary Outcomes (1)

  • kinemaitc asymmetry

    kinemaitc asymmetry during level walking

    Day 1 (After enrollment, a single session for assessment of the gait changes wearing different shoes)

Study Arms (1)

Gait Asymmetry

Individual with gait asymmetry or disorder, which potentially can be modified with shoe's adjustment

Other: Shoe's sole modification

Interventions

Shoe's sole modification by insertion of supporting materials

Gait Asymmetry

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals with gait asymmetry or disorder

You may qualify if:

  • Self-percieved discomforts in lower extremity
  • Be able to walk independently at least for 30 minutes and run independently at least for 10 minutes

You may not qualify if:

  • Obvious foot deformity, trauma in the lower extremity
  • Motor or neurologic disorder that affect walking patterns

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University, Department of Physical Therapy

Taichung, 406040, Taiwan

Location

MeSH Terms

Conditions

Mobility Limitation

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, China Medical University, Department of Physical Therapy

Study Record Dates

First Submitted

February 26, 2025

First Posted

June 4, 2025

Study Start

August 5, 2024

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

August 30, 2026

Last Updated

June 4, 2025

Record last verified: 2025-02

Locations