Brain InjuryNCT05105763
Biofeedback Gait Retraining for Stiff Knee Gait Correction
A study testing Sequential switched feedback training on the knee and the hip (Condition A) and Feedback training on the knee alone (Condition B) in people with Brain Injury, run by Kessler Foundation at 1 site in United States.
Trial summary
The research team has developed a visual kinematic biofeedback system which is designed to help children with hemiplegic cerebral palsy (CP) correct a pattern of reduced knee extension in terminal swing and early stance. The system provides real-time feedback on the knee angle pattern during walking on a treadmill. Read more about this study
- Who is it for?
- Ages 7 to 21 years
- Conditions the study is for
- Brain Injury
- What is being tested?
- Sequential switched feedback training on the knee and the hip (Condition A) and Feedback training on the knee alone (Condition B)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2021to 29 Sep 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 7 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- age 7 to 21;
- has SKG
- diagnosed with brain injury including but not limited to Cerebral Palsy, Stroke,Traumatic Brain Injury;
- ability to walk on a treadmill without assistive devices based on parent/guardian report and/or treatment history;
- the cognitive development is at the level needed to: understand and follow instructions, answer questions, be able to understand the purpose of the study and the activities involved.
Who cannot join
- Botulinum toxin treatment less than 16 weeks before initiation of the study
- Recent or concurrent treatment that might interfere with the study.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Kessler Foundation
West Orange, New Jersey, 07052
Xuan Liu, PhD, 973-324-3561, XLiu@kesslerfoundation.org
Peter Barrance, PhD, 973-324-3550, PBarrance@kesslerfoundation.org
About this study
Official title: Biofeedback Gait Retraining for Stiff Knee Gait Correction: Multi-joint Adaptation in Children and Young Adults With Brain Injury
The research team has developed a visual kinematic biofeedback system which is designed to help children with hemiplegic cerebral palsy (CP) correct a pattern of reduced knee extension in terminal swing and early stance. The system provides real-time feedback on the knee angle pattern during walking on a treadmill. From a pilot study on children with CP, the investigators observed that when the system was used in children who have stiff knee gait (SKG), training with knee feedback alone could lead to an increase in hip flexion which in turn led to limited normalization of the knee pattern through the whole gait cycle. This study, funded by the NIDILRR Switzer grant (PI: X Liu, Ph.D.), seeks to address the question of whether a training design with feedback on both the knee and hip joints would reduce this tendency to generate unintended changes in hip joint motion, and in doing so also improve convergence to the intended knee joint pattern. This study will test ten children and young adults with brain injury who have SKG and examine their short term adaptations to two types of kinematic feedback training: feedback training on the knee alone (condition B) and sequential switched feedback training on the knee and the hip (condition A). An additional sensor placed on the pelvis will be added to the current feedback system for measurement and feedback on the hip joint angle. Software enhancements will also be made with methods that will allow study and description of adaptations in measures of inter-limb symmetry during training. The participants will visit twice with a 2-week washout period between the two visits. Five participants will first undergo condition B in the first visit and then condition A in the second visit, while the other five participants will start with condition A in the first visit and then undergo condition B in the second visit. To compare the effects of the conditions on normalizing the joint angle trajectories, the knee and hip kinematics will be collected and analyzed in both the conditions. To investigate the coordination of lower limb segments under feedback training, relative phase measures will be analyzed on the hip and the knee. To examine whether participants adapt to the feedback retraining in terms of improvement in gait quality, symmetry ratios will be analyzed.
Read the detailed description
Participant characteristics
This study will recruit 10 participants according to the inclusion and exclusion criteria.
System development
In order to measure the quantitative change in hip joint angle online, an additional sensor will be placed on the pelvis segment (overlying the sacrum between the posterior superior iliac spines) and added to the current feedback system. Totally four sensors will be used, including the sensors on the pelvis, thigh, shank, and heel. The hip flexion angle will be calculated from pelvis and thigh sensors. The knee flexion angle will be calculated from thigh and shank sensors, while the heel sensor signal is monitored to isolate strides by detecting contact of the foot with the support surface. To help subjects easily recognize which joint the feedback is cueing for, different backgrounds is selected for the feedback interface for the hip joint and knee joint, respectively. Gait patterns will be video recorded in a sagittal view of the lower extremities. In order to test gait asymmetry by symmetry ratio (dividing the smaller value by the larger value between trained and untrained lower limbs), stance phase duration (% gait cycle) from heel strike to toe off will be identified by motion capturing system with reflective markers. Reflective markers will be placed on the ankles and shoes (fifth metatarsal, heel, rearfoot along the line from heel to toe and below the ankle) on both sides to measure the heel down and toe off events.
Biofeedback gait retraining protocol
Feedback training on the knee alone (Condition B) will include four 6-mins training blocks: 4-mins knee joint feedback-on and 2-mins feedback-off. Sequential switched feedback training on the knee and the hip (Condition A) will include four 6-mins training blocks: 2-mins knee joint feedback-on, 2-mins hip joint feedback-on, and 2-mins feedback-off. Subjects will wear their comfortable footwear and daily used bracing/orthotic devices during the training sessions. Totally four inertial sensors (MTw, Xsens, Netherlands) will be placed separately on the pelvis, anterior thigh, posterior shank and the heel of the paretic lower limb. For calibration purpose, the subject will first stand in his/her natural standing posture and then stand with the knee (weaker side) flexed at 60 degree adding to the knee angle in the natural standing posture. Prior to training, a treadmill walking trial with comfortable speed will be recorded as the baseline trial. After the baseline trial, a 3 minute practice trial will allow interactive demonstration and practice with the goal that the subject has a clear understanding of the task and how to interpret the feedback. In both the two training conditions, subjects will have 3 mins sitting rest between two consecutive blocks to reduce fatigue.
- Conditions
- Brain Injury
- Being tested
- Sequential switched feedback training on the knee and the hip (Condition A), Feedback training on the knee alone (Condition B)
- Keywords
- stiff knee gait, biofeedback
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sequential switched feedback training on the knee and the hip (Condition A)Other
Condition A will include four 6-mins training blocks: 2-mins knee joint feedback-on, 2-mins hip joint feedback-on, and 2-mins feedback-off. Training with feedback on will occur as follows: The subject will walk on the treadmill and try to achieve the target hip and/or knee flexion pattern shown on the feedback interface. Training with feedback off will occur as follows: The subject will walk on the treadmill and try to maintain the pattern without any form of visual or verbal feedback.
Feedback training on the knee alone (Condition B)Other
Condition B will include four 6-mins training blocks: 4-mins knee joint feedback-on and 2-mins feedback-off. Training with feedback on will occur as follows: The subject will walk on the treadmill and try to achieve the target hip and/or knee flexion pattern shown on the feedback interface. Training with feedback off will occur as follows: The subject will walk on the treadmill and try to maintain the pattern without any form of visual or verbal feedback.
| Study group | Role | What they receive |
|---|---|---|
| feedback training on single joint first | Other | Participants in Subgroup 1 will first undergo Condition B in the first visit and then Condition A in the second visit. Receives: Other: Sequential switched feedback training on the knee and the hip (Condition A); Other: Feedback training on the knee alone (Condition B) |
| sequential feedback training on multi-joint first | Other | Participants in Subgroup 2 will start with Condition A in the first visit and then undergo Condition B in the second visit. Receives: Other: Sequential switched feedback training on the knee and the hip (Condition A); Other: Feedback training on the knee alone (Condition B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Root mean square error of the knee flexion angle
The root-mean-square error of the knee flexion angle (RMSE_KF) will be calculated between the measured and target knee flexion angles in the last ten strides of the last trial with feedback off in each training session.
Measured: immediate after the first training session
Root mean square error of the knee flexion angle
The root-mean-square error of the knee flexion angle (RMSE_KF) will be calculated between the measured and target knee flexion angles in the last ten strides of the last trial with feedback off in each training session.
Measured: immediate after the second training session
Peak knee flexion angle
The Peak knee flexion angle (PKF) is the mean maximum knee flexion angles in the last ten strides of the last trial with feedback off.
Measured: immediate after the first training session
Peak knee flexion angle
The Peak knee flexion angle (PKF) is the mean maximum knee flexion angles in the last ten strides of the last trial with feedback off.
Measured: immediate after the second training session
Peak hip flexion angle
The Peak hip flexion angle (PHF) is the mean maximum knee flexion angles in the last ten strides of the last trial with feedback off.
Measured: immediate after the first training session
Peak hip flexion angle
The Peak hip flexion angle (PHF) is the mean maximum knee flexion angles in the last ten strides of the last trial with feedback off.
Measured: immediate after the second training session
Minimum relative phase angle between hip and knee
Minimum relative phase angle between hip and knee is the minimum difference in phase angle between hip and knee. Phase angle is computed as the inverse tangent of angular velocity divided by angular displacement.
Measured: immediate after the first training session
Minimum relative phase angle between hip and knee
Minimum relative phase angle between hip and knee is the minimum difference in phase angle between hip and knee. Phase angle is computed as the inverse tangent of angular velocity divided by angular displacement.
Measured: immediate after the second training session
Symmetry ratio of the stance phase
The symmetry ratio is calculated by dividing the smaller value by the larger value (trained vs. untrained lower limbs) of the stance phase time (% gait cycle). This results in a value between 0.0 and 1.0, with values closer to 1.0 indicating greater symmetry.
Measured: immediate after the first training session
Symmetry ratio of the stance phase
The symmetry ratio is calculated by dividing the smaller value by the larger value (trained vs. untrained lower limbs) of the stance phase time (% gait cycle). This results in a value between 0.0 and 1.0, with values closer to 1.0 indicating greater symmetry.
Measured: immediate after the second training session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start30 Oct 2021
- Primary completion30 Jun 2022 (estimated)
- Study completion29 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuryStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- A counterbalanced repeated measures design will be used in this study to examine the adaptation of children and young adults with brain injury who have SKG to two types of feedback training: feedback training on the knee alone (Condition B) and sequential switched feedback training on the knee and the hip (Condition A). The participants will participate in treadmill training twice with a 2-weeks washout period between the two visits and will receive the two training conditions in different orders. Ten participants will be alternately allocated to two subgroups according to the sequence they are recruited to the study. In the end, the investigators will have five participants in Subgroup 1 and the other five participants in Subgroup 2. Participants in Subgroup 1 will first undergo Condition B in the first visit and then Condition A in the second visit, while participants in Subgroup 2 will start with Condition A in the first visit and then undergo Condition B in the second visit.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Specialized Hospital
- Responsible party
- Sponsor
- Investigators
- Xuan Liu, PhD, Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05105763
- Sponsor's protocol ID
- R-1084-19
- Status last verified
- Mar 2022
- First submitted
- 29 Sep 2021
- Last updated
- 31 Mar 2022
- 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 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biofeedback Gait Retraining for Stiff Knee Gait Correction: Multi-joint Adaptation in Children and Young Adults With Brain Injury
- ClinicalTrials.gov ID
- NCT05105763
- Acronym / sponsor ID
- R-1084-19
- Conditions
- Brain Injury
- Keywords
- stiff knee gait, biofeedback
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Collaborators
- Children's Specialized Hospital
- Study start
- 30 Oct 2021 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 29 Sep 2022 (estimated)
- First posted
- 3 Nov 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.
The research team has developed a visual kinematic biofeedback system which is designed to help children with hemiplegic cerebral palsy (CP) correct a pattern of reduced knee extension in terminal swing and early stance. The system provides real-time feedback on the knee angle pattern during walking on a treadmill. From a pilot study on children with CP, the investigators observed that when the system was used in children who have stiff knee gait (SKG), training with knee feedback alone could lead to an increase in hip flexion which in turn led to limited normalization of the knee pattern through the whole gait cycle. This study, funded by the NIDILRR Switzer grant (PI: X Liu, Ph.D.), seeks to address the question of whether a training design with feedback on both the knee and hip joints would reduce this tendency to generate unintended changes in hip joint motion, and in doing so also improve convergence to the intended knee joint pattern. This study will test ten children and young adults with brain injury who have SKG and examine their short term adaptations to two types of kinematic feedback training: feedback training on the knee alone (condition B) and sequential switched feedback training on the knee and the hip (condition A). An additional sensor placed on the pelvis will be added to the current feedback system for measurement and feedback on the hip joint angle. Software enhancements will also be made with methods that will allow study and description of adaptations in measures of inter-limb symmetry during training. The participants will visit twice with a 2-week washout period between the two visits. Five participants will first undergo condition B in the first visit and then condition A in the second visit, while the other five participants will start with condition A in the first visit and then undergo condition B in the second visit. To compare the effects of the conditions on normalizing the joint angle trajectories, the knee and hip kinematics will be collected and analyzed in both the conditions. To investigate the coordination of lower limb segments under feedback training, relative phase measures will be analyzed on the hip and the knee. To examine whether participants adapt to the feedback retraining in terms of improvement in gait quality, symmetry ratios will be analyzed.
Detailed description
Participant characteristics
This study will recruit 10 participants according to the inclusion and exclusion criteria.
System development
In order to measure the quantitative change in hip joint angle online, an additional sensor will be placed on the pelvis segment (overlying the sacrum between the posterior superior iliac spines) and added to the current feedback system. Totally four sensors will be used, including the sensors on the pelvis, thigh, shank, and heel. The hip flexion angle will be calculated from pelvis and thigh sensors. The knee flexion angle will be calculated from thigh and shank sensors, while the heel sensor signal is monitored to isolate strides by detecting contact of the foot with the support surface. To help subjects easily recognize which joint the feedback is cueing for, different backgrounds is selected for the feedback interface for the hip joint and knee joint, respectively. Gait patterns will be video recorded in a sagittal view of the lower extremities. In order to test gait asymmetry by symmetry ratio (dividing the smaller value by the larger value between trained and untrained lower limbs), stance phase duration (% gait cycle) from heel strike to toe off will be identified by motion capturing system with reflective markers. Reflective markers will be placed on the ankles and shoes (fifth metatarsal, heel, rearfoot along the line from heel to toe and below the ankle) on both sides to measure the heel down and toe off events.
Biofeedback gait retraining protocol
Feedback training on the knee alone (Condition B) will include four 6-mins training blocks: 4-mins knee joint feedback-on and 2-mins feedback-off. Sequential switched feedback training on the knee and the hip (Condition A) will include four 6-mins training blocks: 2-mins knee joint feedback-on, 2-mins hip joint feedback-on, and 2-mins feedback-off. Subjects will wear their comfortable footwear and daily used bracing/orthotic devices during the training sessions. Totally four inertial sensors (MTw, Xsens, Netherlands) will be placed separately on the pelvis, anterior thigh, posterior shank and the heel of the paretic lower limb. For calibration purpose, the subject will first stand in his/her natural standing posture and then stand with the knee (weaker side) flexed at 60 degree adding to the knee angle in the natural standing posture. Prior to training, a treadmill walking trial with comfortable speed will be recorded as the baseline trial. After the baseline trial, a 3 minute practice trial will allow interactive demonstration and practice with the goal that the subject has a clear understanding of the task and how to interpret the feedback. In both the two training conditions, subjects will have 3 mins sitting rest between two consecutive blocks to reduce fatigue.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A counterbalanced repeated measures design will be used in this study to examine the adaptation of children and young adults with brain injury who have SKG to two types of feedback training: feedback training on the knee alone (Condition B) and sequential switched feedback training on the knee and the hip (Condition A). The participants will participate in treadmill training twice with a 2-weeks washout period between the two visits and will receive the two training conditions in different orders. Ten participants will be alternately allocated to two subgroups according to the sequence they are recruited to the study. In the end, the investigators will have five participants in Subgroup 1 and the other five participants in Subgroup 2. Participants in Subgroup 1 will first undergo Condition B in the first visit and then Condition A in the second visit, while participants in Subgroup 2 will start with Condition A in the first visit and then undergo Condition B in the second visit.
| Arm | Type | Receives |
|---|---|---|
| feedback training on single joint first | Other | Other: Sequential switched feedback training on the knee and the hip (Condition A), Other: Feedback training on the knee alone (Condition B)Participants in Subgroup 1 will first undergo Condition B in the first visit and then Condition A in the second visit. |
| sequential feedback training on multi-joint first | Other | Other: Sequential switched feedback training on the knee and the hip (Condition A), Other: Feedback training on the knee alone (Condition B)Participants in Subgroup 2 will start with Condition A in the first visit and then undergo Condition B in the second visit. |
Who may qualify
- Ages
- 7 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- age 7 to 21;
- has SKG
- diagnosed with brain injury including but not limited to Cerebral Palsy, Stroke,Traumatic Brain Injury;
- ability to walk on a treadmill without assistive devices based on parent/guardian report and/or treatment history;
- the cognitive development is at the level needed to: understand and follow instructions, answer questions, be able to understand the purpose of the study and the activities involved.
Key exclusion criteria (2 listed)
- Botulinum toxin treatment less than 16 weeks before initiation of the study
- Recent or concurrent treatment that might interfere with the study.
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 |
|---|---|---|
| Sequential switched feedback training on the knee and the hip (Condition A)Condition A will include four 6-mins training blocks: 2-mins knee joint feedback-on, 2-mins hip joint feedback-on, and 2-mins feedback-off. Training with feedback on will occur as follows: The subject will walk on the treadmill and try to achieve the target hip and/or knee flexion pattern shown on the feedback interface. Training with feedback off will occur as follows: The subject will walk on the treadmill and try to maintain the pattern without any form of visual or verbal feedback. | Other | feedback training on single joint first, sequential feedback training on multi-joint first |
| Feedback training on the knee alone (Condition B)Condition B will include four 6-mins training blocks: 4-mins knee joint feedback-on and 2-mins feedback-off. Training with feedback on will occur as follows: The subject will walk on the treadmill and try to achieve the target hip and/or knee flexion pattern shown on the feedback interface. Training with feedback off will occur as follows: The subject will walk on the treadmill and try to maintain the pattern without any form of visual or verbal feedback. | Other | feedback training on single joint first, sequential feedback training on multi-joint first |
Primary outcome
Root mean square error of the knee flexion angle
Time frame: immediate after the first training session
The root-mean-square error of the knee flexion angle (RMSE_KF) will be calculated between the measured and target knee flexion angles in the last ten strides of the last trial with feedback off in each training session.
Root mean square error of the knee flexion angle
Time frame: immediate after the second training session
The root-mean-square error of the knee flexion angle (RMSE_KF) will be calculated between the measured and target knee flexion angles in the last ten strides of the last trial with feedback off in each training session.
Peak knee flexion angle
Time frame: immediate after the first training session
The Peak knee flexion angle (PKF) is the mean maximum knee flexion angles in the last ten strides of the last trial with feedback off.
Peak knee flexion angle
Time frame: immediate after the second training session
The Peak knee flexion angle (PKF) is the mean maximum knee flexion angles in the last ten strides of the last trial with feedback off.
Peak hip flexion angle
Time frame: immediate after the first training session
The Peak hip flexion angle (PHF) is the mean maximum knee flexion angles in the last ten strides of the last trial with feedback off.
Peak hip flexion angle
Time frame: immediate after the second training session
The Peak hip flexion angle (PHF) is the mean maximum knee flexion angles in the last ten strides of the last trial with feedback off.
Minimum relative phase angle between hip and knee
Time frame: immediate after the first training session
Minimum relative phase angle between hip and knee is the minimum difference in phase angle between hip and knee. Phase angle is computed as the inverse tangent of angular velocity divided by angular displacement.
Minimum relative phase angle between hip and knee
Time frame: immediate after the second training session
Minimum relative phase angle between hip and knee is the minimum difference in phase angle between hip and knee. Phase angle is computed as the inverse tangent of angular velocity divided by angular displacement.
Symmetry ratio of the stance phase
Time frame: immediate after the first training session
The symmetry ratio is calculated by dividing the smaller value by the larger value (trained vs. untrained lower limbs) of the stance phase time (% gait cycle). This results in a value between 0.0 and 1.0, with values closer to 1.0 indicating greater symmetry.
Symmetry ratio of the stance phase
Time frame: immediate after the second training session
The symmetry ratio is calculated by dividing the smaller value by the larger value (trained vs. untrained lower limbs) of the stance phase time (% gait cycle). This results in a value between 0.0 and 1.0, with values closer to 1.0 indicating greater symmetry.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- 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.
Xuan Liu, PhD principal investigator
Kessler Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sequential switched feedback training on the knee and the hip (Condition A) and Feedback training on the knee alone (Condition B) in people with Brain Injury, run by Kessler Foundation at 1 site in United States.
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 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 31 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 United States. 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 Xuan Liu, PhD (973-324-3561, XLiu@kesslerfoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Root mean square error of the knee flexion angle (time frame: immediate after the first training session). The study lists 10 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 31 Mar 2022.