Gait Disorders, NeurologicNCT04968418
Deep Neural Network for Stroke Patient Gait Analysis and Classification
An observational study of Gait Disorders, Neurologic and Artificial Intelligence, run by Cheng-Hsin General Hospital at 1 site in Taiwan.
Trial summary
Lower limbs of stroke patients gradually recover through Brunnstrom stages, from initial flaccid status to gradually increased spasticity, and eventually decreased spasticitiy. Throughout this process. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gait Disorders, Neurologic, Artificial Intelligence
- What is being tested?
- APDM OPAL system wearable IMU
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Jul 2021to 31 May 2023
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Investigators focus on unilateral stroke patient over 20 years old who visit Cheng Hsin General Hospital outpatient clinic on a regular basis.
Who may be able to join
- Age over 20 years old with first time stroke
- And affected lower limb Brunnstrom stage III-V
- Functional ambulation category VI
- Participants should be able to walk on flat surface without assistance for 6 minutes
- Mini-Mental State Examination (MMSE) should be over 25 and can comply to orders and cooperate with our study
Who cannot join
- Severe central nervous system(CNS)/peripheral nervous system(PNS)neurological disorders apart from stroke
- Patients with high risk of falling down during walking
- Patients who cannot cooperate with testing
- Patients with severe visual/auditory/cognition deficits
- Patients with lower limb fracture within recent 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Deep Neural Network for Abnormal Gait Patterns Based on Inertial Sensors Among Post-Stroke Patients
Lower limbs of stroke patients gradually recover through Brunnstrom stages, from initial flaccid status to gradually increased spasticity, and eventually decreased spasticitiy. Throughout this process. after stroke patients can start walking, their gait will show abnormal gait patterns from healthy subjects, including circumduction gait, drop foot, hip hiking and genu recurvatum.
For these abnormal gait patterns, rehabilitation methods include ankle-knee orthosis(AFO) or increasing knee/pelvic joint mobility for assistance. Prior to this study, similar research has been done to differentiate stroke gait patterns from normal gait patterns, with an accuracy of over 96%.
Read more
This study recruits subject who has encountered first ever cerebrovascular incident and can currently walk independently on flat surface without assistance, and investigators record gait information via inertial measurement units strapped to their bilateral ankle, wrist and pelvis to detect acceleration and angular velocity as well as other gait parameters. The IMU used in this study consists of a 3-axis accelerometer, 3-axis gyroscope and 3-axis magnetometer, with a highest sampling rate of 128Hz.
Afterwards, investigators use these gait information collected as training data and testing data for a deep neural network (DNN) model and compare clinical observation results by physicians simultaneously, in order to determine whether the DNN model is able to differentiate the types of abnormal gait patterns mentioned above.
If this model is applied in the community, investigators hope it is available to early detect abnormal gait patterns and perform early intervention to decrease possibility of fallen injuries.
This is a non-invasive observational study and doesn't involve medicine use. Participants are only required to perform walking for 6 minutes without assistance on a flat surface. This risk is extremely low and the only possible risk of this study is falling down during walking.
Read the detailed description
Abnormal gait patterns can be observed among stroke patient who are able to start ambulation training, including circumduction gait, drop foot, hip hiking and genu recurvatum. The first 6 months after a cerebrovascular incident is considered the golden period for post-stroke rehabilitation, therefore intensive intervention during this period will provide significant help to stroke patients. Currently, clinical treatment methods still heavily rely on subjective diagnosis by physiatrists and therapists, therefore investigators hope by establishing a more objective method to classify abnormal gait patterns, it will provide more significant assistance during long term rehabilitation planning.
In this observational study, investigators plan to recruit 100 stroke patients with first ever, unilateral stroke and are able to perform walking on a flat surface for 6 minutes without assistance. Inclusion criteria includes age over 20 years old with first time stroke and affected lower limb Brunnstrom stage III-V, and functional ambulation category VI. Participants should be able to walk on a flat surface without assistance for 6 minutes and their Mini-Mental State Examination (MMSE) should be over 25, which means participants can comply to orders and cooperate with investigators in this study. Exclusion criteria includes severe central nervous system (CNS)/peripheral neurological disorders apart from stroke, and those with high risk of falling down during walking. Those who cannot cooperate with testing and with severe visual/auditory/cognition deficits are also excluded. Patients with lower limb fracture within recent 6 months are excluded as well.
Investigators recruit participants from outpatient clinics as well as physical therapy rooms and patients will not receive any extra medications before/after this gait study. Participants will continue their physical therapy programs as well as medical regime without any restriction by participating this study. The study method in this study is to strap multiple inertial measurement units (IMUs) on participants' bilateral wrists, ankles and pelvis, and participants are requested to walk indoors on a flat surface for 6 minutes under their most comfortable pace. The IMUs used in this study consists of a 3-axis accelerometer, 3-axis gyroscope and 3-axis magnetometer, with a highest sampling rate of 128Hz. Non-invasive orthosis such as ankle-foot orthosis (AFO) are allowed to increase gait stability and symmetry. Meanwhile, experienced clinical physiatrists and physical therapists will record whether the patients' gait patterns show abnormal gait patterns such as circumduction gait, drop foot, hip hiking or back knee. The participants are allowed to leave after completion of 6 minute walking test without any discomfort.
A deep neural network (DNN) model is constructed to be trained for abnormal gait pattern analysis. The DNN model constructed for this study consists of an input layer, 6 hidden layers, detection output layer and classification output layer. Each hidden layer consists of 100 neurons and detection output layer will label each gait data as normal gait[1,0] or stroke gait[0,1]. Afterwards, the classification layer will label each abnormal stroke gait pattern as stroke gait, circumduction gait, drop foot, hip hiking and back knee as [1,1,1,1,1]. After completion of collecting clinical gait data from participants in this study, investigators use the collected gait data for DNN training, and investigators use k-fold cross validation method to divide participants' gait data into 5 collections randomly, with 4 of them used as training data while the remaining used as testing data, and the testing will be repeated for 5 times. Then investigators will compare clinical observed information done by physiatrists/therapists and DNN model results to see whether the DNN model is available of differentiating circumduction gait, drop foot, hip hiking and genu recurvatum.
- Being tested
- APDM OPAL system wearable IMU
- Medical subject headings
- Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APDM OPAL system wearable IMUDevice
The OPAL system contains wearable IMUs with a sampling rate of 128 Hz and a resolution of 17.5 bits. Each IMU has a size of about 44mm 40mm 14mm × × and weighs less than 25 gm.
What is being measured
The primary outcome is the main question the study is designed to answer.
Deep neural network (DNN) model accuracy of detecting abnormal stroke gait patterns
Investigators compare clinically observed abnormal gait patterns with DNN model detection. Accuracy of the DNN model will be compared to clinical observed data after cross validation, which results in a series of labeling. Investigators compare those labels with actual observed clinical abnormal gait patterns to determine whether DNN is available of identifying abnormal stroke gait patterns accurately.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start20 Jul 2021
- Primary completion1 May 2023 (estimated)
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gait Disorders, NeurologicStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cheng-Hsin General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University
- Responsible party
- Sponsor
- Investigators
- Szu-Fu Chen, MD, PHD, Study director, Szu-Fu Chen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04968418
- Sponsor's protocol ID
- (870)110-16
- Status last verified
- Mar 2022
- First submitted
- 8 Jul 2021
- Last updated
- 9 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: According to the investigator's IRB statement, patient information will only be used in this research and will not be used for other purposes.
Publications
Kerrigan DC, Frates EP, Rogan S, Riley PO. Hip hiking and circumduction: quantitative definitions. Am J Phys Med Rehabil. 2000 May-Jun;79(3):247-52. doi: 10.1097/00002060-200005000-00006.
PubMed 10821310Trojaniello D, Cereatti A, Pelosin E, Avanzino L, Mirelman A, Hausdorff JM, Della Croce U. Estimation of step-by-step spatio-temporal parameters of normal and impaired gait using shank-mounted magneto-inertial sensors: application to elderly, hemiparetic, parkinsonian and choreic gait. J Neuroeng Rehabil. 2014 Nov 11;11:152. doi: 10.1186/1743-0003-11-152.
PubMed 25388296Abaid N, Cappa P, Palermo E, Petrarca M, Porfiri M. Gait detection in children with and without hemiplegia using single-axis wearable gyroscopes. PLoS One. 2013 Sep 4;8(9):e73152. doi: 10.1371/journal.pone.0073152. eCollection 2013.
PubMed 24023825
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Deep Neural Network for Abnormal Gait Patterns Based on Inertial Sensors Among Post-Stroke Patients
- ClinicalTrials.gov ID
- NCT04968418
- Acronym / sponsor ID
- (870)110-16
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cheng-Hsin General HospitalUniversity, hospital or other
- Collaborators
- National Taiwan University
- Study start
- 20 Jul 2021 (actual)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 20 Jul 2021 (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.
Lower limbs of stroke patients gradually recover through Brunnstrom stages, from initial flaccid status to gradually increased spasticity, and eventually decreased spasticitiy. Throughout this process. after stroke patients can start walking, their gait will show abnormal gait patterns from healthy subjects, including circumduction gait, drop foot, hip hiking and genu recurvatum.
For these abnormal gait patterns, rehabilitation methods include ankle-knee orthosis(AFO) or increasing knee/pelvic joint mobility for assistance. Prior to this study, similar research has been done to differentiate stroke gait patterns from normal gait patterns, with an accuracy of over 96%.
This study recruits subject who has encountered first ever cerebrovascular incident and can currently walk independently on flat surface without assistance, and investigators record gait information via inertial measurement units strapped to their bilateral ankle, wrist and pelvis to detect acceleration and angular velocity as well as other gait parameters. The IMU used in this study consists of a 3-axis accelerometer, 3-axis gyroscope and 3-axis magnetometer, with a highest sampling rate of 128Hz.
Afterwards, investigators use these gait information collected as training data and testing data for a deep neural network (DNN) model and compare clinical observation results by physicians simultaneously, in order to determine whether the DNN model is able to differentiate the types of abnormal gait patterns mentioned above.
If this model is applied in the community, investigators hope it is available to early detect abnormal gait patterns and perform early intervention to decrease possibility of fallen injuries.
This is a non-invasive observational study and doesn't involve medicine use. Participants are only required to perform walking for 6 minutes without assistance on a flat surface. This risk is extremely low and the only possible risk of this study is falling down during walking.
Detailed description
Abnormal gait patterns can be observed among stroke patient who are able to start ambulation training, including circumduction gait, drop foot, hip hiking and genu recurvatum. The first 6 months after a cerebrovascular incident is considered the golden period for post-stroke rehabilitation, therefore intensive intervention during this period will provide significant help to stroke patients. Currently, clinical treatment methods still heavily rely on subjective diagnosis by physiatrists and therapists, therefore investigators hope by establishing a more objective method to classify abnormal gait patterns, it will provide more significant assistance during long term rehabilitation planning.
In this observational study, investigators plan to recruit 100 stroke patients with first ever, unilateral stroke and are able to perform walking on a flat surface for 6 minutes without assistance. Inclusion criteria includes age over 20 years old with first time stroke and affected lower limb Brunnstrom stage III-V, and functional ambulation category VI. Participants should be able to walk on a flat surface without assistance for 6 minutes and their Mini-Mental State Examination (MMSE) should be over 25, which means participants can comply to orders and cooperate with investigators in this study. Exclusion criteria includes severe central nervous system (CNS)/peripheral neurological disorders apart from stroke, and those with high risk of falling down during walking. Those who cannot cooperate with testing and with severe visual/auditory/cognition deficits are also excluded. Patients with lower limb fracture within recent 6 months are excluded as well.
Investigators recruit participants from outpatient clinics as well as physical therapy rooms and patients will not receive any extra medications before/after this gait study. Participants will continue their physical therapy programs as well as medical regime without any restriction by participating this study. The study method in this study is to strap multiple inertial measurement units (IMUs) on participants' bilateral wrists, ankles and pelvis, and participants are requested to walk indoors on a flat surface for 6 minutes under their most comfortable pace. The IMUs used in this study consists of a 3-axis accelerometer, 3-axis gyroscope and 3-axis magnetometer, with a highest sampling rate of 128Hz. Non-invasive orthosis such as ankle-foot orthosis (AFO) are allowed to increase gait stability and symmetry. Meanwhile, experienced clinical physiatrists and physical therapists will record whether the patients' gait patterns show abnormal gait patterns such as circumduction gait, drop foot, hip hiking or back knee. The participants are allowed to leave after completion of 6 minute walking test without any discomfort.
A deep neural network (DNN) model is constructed to be trained for abnormal gait pattern analysis. The DNN model constructed for this study consists of an input layer, 6 hidden layers, detection output layer and classification output layer. Each hidden layer consists of 100 neurons and detection output layer will label each gait data as normal gait[1,0] or stroke gait[0,1]. Afterwards, the classification layer will label each abnormal stroke gait pattern as stroke gait, circumduction gait, drop foot, hip hiking and back knee as [1,1,1,1,1]. After completion of collecting clinical gait data from participants in this study, investigators use the collected gait data for DNN training, and investigators use k-fold cross validation method to divide participants' gait data into 5 collections randomly, with 4 of them used as training data while the remaining used as testing data, and the testing will be repeated for 5 times. Then investigators will compare clinical observed information done by physiatrists/therapists and DNN model results to see whether the DNN model is available of differentiating circumduction gait, drop foot, hip hiking and genu recurvatum.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Investigators focus on unilateral stroke patient over 20 years old who visit Cheng Hsin General Hospital outpatient clinic on a regular basis.
Key inclusion criteria (5 listed)
- Age over 20 years old with first time stroke
- And affected lower limb Brunnstrom stage III-V
- Functional ambulation category VI
- Participants should be able to walk on flat surface without assistance for 6 minutes
- Mini-Mental State Examination (MMSE) should be over 25 and can comply to orders and cooperate with our study
Key exclusion criteria (5 listed)
- Severe central nervous system(CNS)/peripheral nervous system(PNS)neurological disorders apart from stroke
- Patients with high risk of falling down during walking
- Patients who cannot cooperate with testing
- Patients with severe visual/auditory/cognition deficits
- Patients with lower limb fracture within recent 6 months
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 |
|---|---|---|
| APDM OPAL system wearable IMUThe OPAL system contains wearable IMUs with a sampling rate of 128 Hz and a resolution of 17.5 bits. Each IMU has a size of about 44mm 40mm 14mm × × and weighs less than 25 gm. | Device | – |
Primary outcome
Deep neural network (DNN) model accuracy of detecting abnormal stroke gait patterns
Time frame: 2 years
Investigators compare clinically observed abnormal gait patterns with DNN model detection. Accuracy of the DNN model will be compared to clinical observed data after cross validation, which results in a series of labeling. Investigators compare those labels with actual observed clinical abnormal gait patterns to determine whether DNN is available of identifying abnormal stroke gait patterns accurately.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- Background: PubMed 10821310Kerrigan DC, Frates EP, Rogan S, Riley PO. Hip hiking and circumduction: quantitative definitions. Am J Phys Med Rehabil. 2000 May-Jun;79(3):247-52. doi: 10.1097/00002060-200005000-00006.
- Background: PubMed 25388296Trojaniello D, Cereatti A, Pelosin E, Avanzino L, Mirelman A, Hausdorff JM, Della Croce U. Estimation of step-by-step spatio-temporal parameters of normal and impaired gait using shank-mounted magneto-inertial sensors: application to elderly, hemiparetic, parkinsonian and choreic gait. J Neuroeng Rehabil. 2014 Nov 11;11:152. doi: 10.1186/1743-0003-11-152.
- Background: PubMed 24023825Abaid N, Cappa P, Palermo E, Petrarca M, Porfiri M. Gait detection in children with and without hemiplegia using single-axis wearable gyroscopes. PLoS One. 2013 Sep 4;8(9):e73152. doi: 10.1371/journal.pone.0073152. eCollection 2013.
- Individual participant dataSharing planned: No. According to the investigator's IRB statement, patient information will only be used in this research and will not be used for other purposes.
Related trials for Gait Disorders, Neurologic
Recruiting
Evaluating Long-term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children With Movement Disorders
Cerebral Palsy, Muscular Dystrophy
Recruiting
Decoding the Neural Mechanisms Underlying Postural Instability and Gait Dysfunction in Parkinson's Disease
Parkinson Disease, Freezing of Gait
RecruitingPhase 4
Xeomin® and Gait Related Mobility After Stroke
Stroke
Enrolling by invitation
AI-Guided Multi-Electrode Transcutaneous Spinal Cord Stimulation for Gait Rehabilitation in People With Spinal Cord Injury or Stroke
Spinal Cord Injuries (SCI)
Active, not recruitingObservational study
Focused Intensive Repeated Stepping During Inpatient Rehabilitation Poststroke - A Quality Improvement Project
Stroke, Acute, Gait, Hemiplegic
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.
Szu-Fu Chen, MD, PHD study director
Szu-Fu Chen
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 Gait Disorders, Neurologic and Artificial Intelligence, run by Cheng-Hsin General Hospital at 1 site in Taiwan.
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 5 inclusion and 5 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 9 Mar 2022. 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 Taiwan. 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?
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?
Deep neural network (DNN) model accuracy of detecting abnormal stroke gait patterns (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04968418, which also lists 3 linked publications.
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 9 Mar 2022.