Sport InjuryNCT04462913
Biometric Recognition and Rehabilitation Assessment of Lower Extremity Sports Injury Based on Gait Touch Information
An observational study of Sport Injury and Osteoarthritis, Knee, run by Peking University Third Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Sport Injury, Osteoarthritis, Knee
- How many people
- 550 participants
- Where
- 1 siteChina
- Study dates
- 28 Jul 2017to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- Cognitive impairment
- other injuries affecting movement performance.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, 100191
Hongshi Huang, Doctor, +8613910093298, huanghs@bjmu.edu.cn
About this study
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.
Read the 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.
- Conditions
- Sport Injury, Osteoarthritis, Knee
- Being tested
- no intervention
- Keywords
- sports injury, gait touch information, machine learning
- Medical subject headings
- Osteoarthritis, Knee, Athletic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
This is an observation study, with no intervention
| Study group | Role | What they receive |
|---|---|---|
| Healthy control | According to the previous clinical diagnosis, volunteers who has never suffered the lower extremity sports injuries. Receives: 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). Receives: Other: no intervention | |
| Patients with degenerative osteoarthritis | According to the previous clinical diagnosis, patients who has suffered the degenerative osteoarthritis. Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
walking speed
Three-dimensional gait analysis system and plantar pressure were used during walking.
Measured: On the day of enrollment.
ground reaction force
Three-dimensional gait analysis system and plantar pressure were used during walking.
Measured: On the day of enrollment.
knee flexion angle
Three-dimensional gait analysis system and plantar pressure were used during walking.
Measured: 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.
Measured: On the day of enrollment.
Secondary outcomes (1)
The International Knee Documentation Committee (IKDC) score
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.
Measured: On the day of enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start28 Jul 2017
- Primary completion1 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sport InjuryStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hongshi Huang, Doctor, Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04462913
- Sponsor's protocol ID
- OR001
- Status last verified
- Jun 2020
- First submitted
- 29 Jun 2020
- Last updated
- 8 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biometric Recognition and Rehabilitation Assessment of Lower Extremity Sports Injury Based on Gait Touch Information
- ClinicalTrials.gov ID
- NCT04462913
- Acronym / sponsor ID
- OR001
- Conditions
- Sport Injury, Osteoarthritis, Knee
- Keywords
- sports injury, gait touch information, machine learning
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 28 Jul 2017 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 8 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy control | – | Other: no interventionAccording to the previous clinical diagnosis, volunteers who has never suffered the lower extremity sports injuries. |
| Patients with sports injuries | – | Other: no interventionAccording to the previous clinical diagnosis, patients who has suffered the sports injuries(including hip, knee, and ankle joint diseases). |
| Patients with degenerative osteoarthritis | – | Other: no interventionAccording to the previous clinical diagnosis, patients who has suffered the degenerative osteoarthritis. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (2 listed)
- Cognitive impairment
- other injuries affecting movement performance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionThis is an observation study, with no intervention | Other | Healthy control, Patients with degenerative osteoarthritis, Patients with sports injuries |
Primary outcome
walking speed
Time frame: On the day of enrollment.
Three-dimensional gait analysis system and plantar pressure were used during walking.
ground reaction force
Time frame: On the day of enrollment.
Three-dimensional gait analysis system and plantar pressure were used during walking.
knee flexion angle
Time frame: On the day of enrollment.
Three-dimensional gait analysis system and plantar pressure were used during walking.
the moment of knee extension in the gait cycle
Time frame: On the day of enrollment.
Three-dimensional gait analysis system and plantar pressure were used during walking.
1 secondary outcome
The International Knee Documentation Committee (IKDC) score
Time frame: On the day of enrollment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hongshi Huang, Doctor study chair
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sport Injury and Osteoarthritis, Knee, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongshi Huang, Doctor (+8613910093298, huanghs@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
walking speed (time frame: On the day of enrollment.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2020.