Cervical Spine MyelopathyNCT06242054
Motor Function Assessment System Based on Video Tracking and Artificial Intelligence Technique
A study testing Motor Function Assessment System in people with Cervical Spine Myelopathy, run by Peking University Third Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to develop a motion recognition system based on video tracking technology and combine it with artificial intelligence technology to form a motion recognition and function evaluation system in in healthy people and patients with cervical spondylotic myelopathy. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervical Spine Myelopathy
- What is being tested?
- Motor Function Assessment System
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Dec 2022
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Study Group: 1. Patients with cervical spondylotic myelopathy diagnosed by clinical symptoms and cervical spine imaging examination (including cervical flexion and extension X-ray, cervical spine CT and cervical spine MRI).
- Control Group: 1. Healthy people without clinical and imaging manifestations of cervical spondylotic myelopathy.
- Age 18-80 years old.
- Can complete the informed consent process.
Who cannot join
- Patients with hand dysfunction caused by other reasons (such as rheumatoid arthritis, history of hand trauma, history of hand surgery, etc.).
- Patients who cannot complete the assessment process due to various reasons.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Development and Clinical Application of a Motor Function Assessment System Based on Video Tracking and Artificial Intelligence Technique
The goal of this clinical trial is to develop a motion recognition system based on video tracking technology and combine it with artificial intelligence technology to form a motion recognition and function evaluation system in in healthy people and patients with cervical spondylotic myelopathy. The main questions it aims to answer are:
- The development of this motion recognition system,
- In the scenario of hand motor dysfunction, the key parameters of hand movement in healthy people and patients with cervical spondylotic myelopathy were evaluated, and the hand motor function model was established to achieve an objective, highly sensitive, highly specific, repeatable and easy-to-use system in clinical hand motor function evaluation.
Read more
Participants will recieved the evaluation of this system and mJOA before the surgery.
If there is a comparison group: Researchers will compare the evaluation results of healthy people to see if this system could recognized the hand motor dysfunction of patients with cervical spondylotic myelopathy.
- Conditions
- Cervical Spine Myelopathy
- Being tested
- Motor Function Assessment System
- Keywords
- Cervical spine myelopathy, Hand motor funciton, Video tracking technology, Artificial intelligence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor Function Assessment SystemDiagnostic test
Participants were instructed to extend their fingers and subsequently clench their fists to the maximum possible range of motion, in order to complete the evaluation of Motor Function Assessment System.
| Study group | Role | What they receive |
|---|---|---|
| Patients with cervical spine myelopathy | Experimental | Not described Receives: Diagnostic Test: Motor Function Assessment System |
| Healthy people | Other | Not described Receives: Diagnostic Test: Motor Function Assessment System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Function Assessment System
Motor Function Assessment System
Measured: Before the surgery
mJOA
mJOA
Measured: Before the surgery
10-Seconds Grab and Release Test
10-Seconds Grab and Release Test
Measured: Before the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start1 Jan 2021
- Primary completion1 Jun 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Spine MyelopathyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhou Feifei, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06242054
- Sponsor's protocol ID
- M2021454
- Status last verified
- Jan 2024
- First submitted
- 28 Jan 2024
- Last updated
- 5 Feb 2024
- Results posted
- 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 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development and Clinical Application of a Motor Function Assessment System Based on Video Tracking and Artificial Intelligence Technique
- ClinicalTrials.gov ID
- NCT06242054
- Acronym / sponsor ID
- M2021454
- Conditions
- Cervical Spine Myelopathy
- Keywords
- Cervical spine myelopathy, Hand motor funciton, Video tracking technology, Artificial intelligence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 5 Feb 2024 (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 goal of this clinical trial is to develop a motion recognition system based on video tracking technology and combine it with artificial intelligence technology to form a motion recognition and function evaluation system in in healthy people and patients with cervical spondylotic myelopathy. The main questions it aims to answer are:
- The development of this motion recognition system,
- In the scenario of hand motor dysfunction, the key parameters of hand movement in healthy people and patients with cervical spondylotic myelopathy were evaluated, and the hand motor function model was established to achieve an objective, highly sensitive, highly specific, repeatable and easy-to-use system in clinical hand motor function evaluation.
Participants will recieved the evaluation of this system and mJOA before the surgery.
If there is a comparison group: Researchers will compare the evaluation results of healthy people to see if this system could recognized the hand motor dysfunction of patients with cervical spondylotic myelopathy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with cervical spine myelopathy | Experimental | Diagnostic Test: Motor Function Assessment System |
| Healthy people | Other | Diagnostic Test: Motor Function Assessment System |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Study Group: 1. Patients with cervical spondylotic myelopathy diagnosed by clinical symptoms and cervical spine imaging examination (including cervical flexion and extension X-ray, cervical spine CT and cervical spine MRI).
- Control Group: 1. Healthy people without clinical and imaging manifestations of cervical spondylotic myelopathy.
- Age 18-80 years old.
- Can complete the informed consent process.
Key exclusion criteria (2 listed)
- Patients with hand dysfunction caused by other reasons (such as rheumatoid arthritis, history of hand trauma, history of hand surgery, etc.).
- Patients who cannot complete the assessment process due to various reasons.
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 |
|---|---|---|
| Motor Function Assessment SystemParticipants were instructed to extend their fingers and subsequently clench their fists to the maximum possible range of motion, in order to complete the evaluation of Motor Function Assessment System. | Diagnostic test | Healthy people, Patients with cervical spine myelopathy |
Primary outcome
Motor Function Assessment System
Time frame: Before the surgery
Motor Function Assessment System
mJOA
Time frame: Before the surgery
mJOA
10-Seconds Grab and Release Test
Time frame: Before the surgery
10-Seconds Grab and Release Test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor Function Assessment System in people with Cervical Spine Myelopathy, 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 4 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: finished, as of the sponsor's last update on 5 Feb 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor Function Assessment System (time frame: Before the surgery). The study lists 3 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 5 Feb 2024.