- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04462913
Biometric Recognition and Rehabilitation Assessment of Lower Extremity Sports Injury Based on Gait Touch Information
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background:
The current common clinical methods cannot truly reflect the biomechanical status of the knee joint. The three-dimensional gait analysis is the gold standard, but it is difficult to apply clinically. There is an urgent need for a clinically practical method to quantitatively evaluate the biomechanics of the knee joint under dynamic weight bearing.
Methods:
50 healthy volunteers, 450 sports injuries patients (including hip, knee, and ankle joint diseases) and 50 patients with degenerative osteoarthritis were recruited.
55 passive reflective markers were placed bilaterally on the body. Lower extremity kinematics and dynamic plantar pressure during walking, jogging were collected.
Outcome evaluation indicators and statistical methods: The following indicators use repeated measurement two-factor analysis of variance: the left and right sides, different rehabilitation times are used as repeated measurement variables, to analyze the biomechanical changes of the lower limb joint biomechanics and gait touch information. A variety of machine learning methods (such as PCA, SVM, CNN, etc.) are used to analyze, and select the appropriate algorithm and parameters according to the learning effect. Finally, this study will establish a machine learning models for computer-aided diagnosis, treatment, and rehabilitation assessment.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
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Beijing, China, 100191
- Recruiting
- Peking University Third Hospital
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Contact:
- Hongshi Huang, Doctor
- Phone Number: +8613910093298
- Email: huanghs@bjmu.edu.cn
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
Inclusion Criteria:
- 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 Criteria:
- Cognitive impairment
- other injuries affecting movement performance.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Healthy control
According to the previous clinical diagnosis, volunteers who has never suffered the lower extremity sports injuries.
|
This is an observation study, with 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).
|
This is an observation study, with no intervention
|
|
Patients with degenerative osteoarthritis
According to the previous clinical diagnosis, patients who has suffered the degenerative osteoarthritis.
|
This is an observation study, with no intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
walking speed
Time Frame: On the day of enrollment.
|
Three-dimensional gait analysis system and plantar pressure were used during walking.
|
On the day of enrollment.
|
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ground reaction force
Time Frame: On the day of enrollment.
|
Three-dimensional gait analysis system and plantar pressure were used during walking.
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On the day of enrollment.
|
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knee flexion angle
Time Frame: On the day of enrollment.
|
Three-dimensional gait analysis system and plantar pressure were used during walking.
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On the day of enrollment.
|
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the moment of knee extension in the gait cycle
Time Frame: On the day of enrollment.
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Three-dimensional gait analysis system and plantar pressure were used during walking.
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On the day of enrollment.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The International Knee Documentation Committee (IKDC) score
Time Frame: On the day of enrollment.
|
The International Knee Documentation Committee (IKDC) score was used to evaluate the knee health.The patients completed score by themselves.
The lowest score is 0 and the highest score is 100.
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On the day of enrollment.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- OR001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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