NCT04462913

Brief Summary

The current common clinical methods cannot truly reflect the biomechanical status of the knee joint. Based on the foot-knee coupling mechanism, the simple and practical dynamic gait touch information provided by the 3D force platform are closely related to the knee biomechanics. The purpose of this study is to investigate the disease feature recognition, computer-aided diagnosis and rehabilitation assessment based on the gait touch information related to lower limb injuries.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
550

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 28, 2017

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 8, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

July 8, 2020

Status Verified

June 1, 2020

Enrollment Period

5.3 years

First QC Date

June 29, 2020

Last Update Submit

July 6, 2020

Conditions

Keywords

sports injurygait touch informationmachine learning

Outcome Measures

Primary Outcomes (4)

  • walking speed

    Three-dimensional gait analysis system and plantar pressure were used during walking.

    On the day of enrollment.

  • ground reaction force

    Three-dimensional gait analysis system and plantar pressure were used during walking.

    On the day of enrollment.

  • knee flexion angle

    Three-dimensional gait analysis system and plantar pressure were used during walking.

    On the day of enrollment.

  • the moment of knee extension in the gait cycle

    Three-dimensional gait analysis system and plantar pressure were used during walking.

    On the day of enrollment.

Secondary Outcomes (1)

  • The International Knee Documentation Committee (IKDC) score

    On the day of enrollment.

Study Arms (3)

Healthy control

According to the previous clinical diagnosis, volunteers who has never suffered the lower extremity sports injuries.

Other: no intervention

Patients with sports injuries

According to the previous clinical diagnosis, patients who has suffered the sports injuries(including hip, knee, and ankle joint diseases).

Other: no intervention

Patients with degenerative osteoarthritis

According to the previous clinical diagnosis, patients who has suffered the degenerative osteoarthritis.

Other: no intervention

Interventions

This is an observation study, with no intervention

Healthy controlPatients with degenerative osteoarthritisPatients with sports injuries

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Inclusion: one healthy control group: healthy volunteers; and patients with a certain sports injury (soft tissue injury or degenerative osteoarthritis) of a joint of the lower limb (hip or knee or ankle or foot). Exclusion: Cognitive impairment or other injuries affecting movement performance.

You may qualify if:

  • patients with a certain sports injury (soft tissue injury or degenerative osteoarthritis) of a joint of the lower limb (hip or knee or ankle or foot).

You may not qualify if:

  • Cognitive impairment
  • other injuries affecting movement performance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, 100191, China

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, KneeAthletic Injuries

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesWounds and Injuries

Study Officials

  • Hongshi Huang, Doctor

    Peking University Third Hospital

    STUDY CHAIR

Central Study Contacts

Hongshi Huang, Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2020

First Posted

July 8, 2020

Study Start

July 28, 2017

Primary Completion

December 1, 2022

Study Completion

December 30, 2022

Last Updated

July 8, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations