Hemiplegic Cerebral PalsyNCT04088994
Action Observation Based Rehabilitation of Children With Unilateral Cerebral Palsy
A study testing AOT Pathological Model Experimental Group in people with Hemiplegic Cerebral Palsy and Motor Activity, run by University of Parma at 1 site in Italy.
Trial summary
Recent evidence suggested that Action Observation Therapy (AOT), based on observation of actions followed by immediate reproduction, could be a useful rehabilitative strategy for promoting functional recovery of children affected by Unilateral Cerebral Palsy (UCP). Read more about this study
- Who is it for?
- Ages 6 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemiplegic Cerebral Palsy, Motor Activity
- What is being tested?
- AOT Pathological Model Experimental Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteItaly
- Study dates
- 3 Dec 2019to 16 Feb 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 6 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- confirmed diagnosis of UCP according to definition (MRI and clinical history)
- age 6-16 years at the time of recruitment;
- mild or moderate disability of the upper limb: score between 4 and 7 according to the House Functional Classification (HFC) system;
- sufficient cooperation and understanding to participate in the activities, according to the doctor/physiotherapist who is treating the child and to the neuropsychological evaluation.
Who cannot join
- cognitive, visual or auditory impairments;
- history of seizures or seizures not well controlled by therapy;
- upper limb surgery within 8 months prior to enrollment;
- upper limb botulinum toxin injection (BoNT-A) within 6 months prior to enrollment.
- Additional exclusion criteria for participants in fMRI sessions:
- insufficient cooperation to participation in neuroimaging studies lasting about 30 minutes;
- presence of contraindications to instrumental investigations using 3 Tesla Magnetic Resonance system (implants, metal prostheses, shunts etc.). The presence of these contraindications will be verified by the use of a preliminary questionnaire administered to the parents.
- < 9 years at the time of recruitment.
Trial locations and contacts
1 site in 1 country.
Italy1 site
IRCCS S. Maria Nuova Hospital - Rehabilitation unit for severe disabilities in the developmental age
Reggio Emilia, 42123
About this study
Official title: Rehabilitation of Hemiplegic Cerebral Palsy Children: Role of Motor Activity and Action Observation Therapy in the Recovery of the Affected Upper Limb
Recent evidence suggested that Action Observation Therapy (AOT), based on observation of actions followed by immediate reproduction, could be a useful rehabilitative strategy for promoting functional recovery of children affected by Unilateral Cerebral Palsy (UCP).
The AOT is based on the discovery of mirror neurons, a class of visuomotor neurons that are activated when the individual performs a targeted action, both when observing the same action performed by another individual.
Read more
An important assumption of AOT is that the mirror system, thanks to its visuomotor properties, is able to coordinate visual information with the observer's motor experience. Indeed, the actions outside the individual's behavioral repertoire are elaborated and categorized only on the basis of visual characteristics, without inducing any phenomenon of motor resonance in the observer's brain.
Therefore, given the deficiency of their motor repertoire, children affected by UCP could have a reduced activation of the mirror system during the observation of actions performed by healthy subjects. Nevertheless, this activation could increase during the observation of the same actions performed by a subject with similar motor strategies, due to a similar form of hemiplegia.
The present project is a randomized controlled clinical trial to verify the influence of the observed model on the effectiveness of AOT in the rehabilitation of the affected upper limb in children with UCP. In particular, the study will verify whether the rehabilitation through AOT based on a pathological model (improving the patient's current abilities) gives more results than AOT based on a typical (healthy) development model, as reported by all the documented researches in literature.
Furthermore, to investigate the functional reorganization of the sensorimotor system after rehabilitative treatment, a subgroup of participants will be subjected to a fMRI session (Functional Magnetic Resonance), to verify functional changes, comparing data before and after AOT.
Read the detailed description
The study will compare two rehabilitation models through AOT to assess feasibility and effectiveness. In the preliminary phase of the study a single rehabilitation treatment protocol will be planned, based on the observation and execution of unimanual and bimanual actions integrated in activities that are significant for the subject's age group. The recorded actions will be performed by a child with typical development and by two hemiplegic children:
- upper limb disability with grades between 4-5 according to House Functional Classification (HFC) system (corresponding to synergic hand of Ferrari and Cioni's Kinematic Hand Classification).
- upper limb disability with grades between 6-7 according to HFC system (corresponding to subfunctional hand of Ferrari and Cioni's Kinematic Hand Classification).
The participants (N. 26) randomly assigned to the experimental group will be subjected to the rehabilitation protocol through AOT based on the observation of the "Pathological Model". The model, while showing a manipulation strategy similar to that of the study participant, will show an improvement with respect to the patient's current abilities. The children randomly assigned to the control group will be subjected to the rehabilitation treatment protocol through AOT based on the "Typical developmental model".
Both experimental and control treatment will consist of a minimum of 10 hours (min. 10, max 15) for a period of 15 consecutive working days (3 weeks). Each video sequence will show a specific action repeated several times for 3 minutes. Subsequently, participants will be asked to perform the action observed with their hemiplegic upper limb or with both upper limbs for a maximum of 3 repetitions.
A subgroup of study participants (N. 8+8) from both groups will undergo two fMRI sessions, before and immediately after the AOT.
The fMRI session consists of two experimental tasks:
- action observation (functional session 1-2), in which patients will observe short videos in which actions are performed with the right hand from a subjective perspective.
- motor task (session 3), in which actions consist in reaching-grasping an object (a cube, a sphere or a cylinder) and putting it into boxes, placed on the right and on the left of the object.
The study consists of two experimental conditions:
- Observation of the paretic hand, in which the actions will be performed by another patient with UCP.
- Observation of the healthy hand, in which the action will be reproduced by a healthy model.
The aim of the study is to investigate the functional reorganization of sensorimotor system comparing functional activation before and after rehabilitation with AOT.
- Conditions
- Hemiplegic Cerebral Palsy, Motor Activity
- Being tested
- AOT Pathological Model Experimental Group, AOT Healthy Model Control Group
- Keywords
- Hemiplegic Cerebral Palsy, Mirror neuron System, Action Observation, Rehabilitation, fMRI
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AOT Pathological Model Experimental GroupOther
Also called Pathological Model
The children will participate in a rehabilitation intervention based on the observation of unimanual and bimanual actions performed by a model with the same degree of motor impairment, but an improvement on the participant's current abilities.
AOT Healthy Model Control GroupOther
Also called Healthy Model
The children assigned to the healthy group will participate in a rehabilitative protocol based on the AOT observing unimanual and bimanual actions performed by a healthy model
| Study group | Role | What they receive |
|---|---|---|
| pathological model | Experimental | The children assigned to the experimental group will participate in a rehabilitative protocol based on the AOT observing unimanual and bimanual actions performed by a model with a similar manipulation strategy but improved with respect to the child's current abilities. Receives: Other: AOT Pathological Model Experimental Group |
| Healthy model | Active comparator | The children assigned to the control group will participate in a rehabilitative protocol based on the AOT observing unimanual and bimanual actions performed by a healthy model Receives: Other: AOT Healthy Model Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Assisting Hand Assessment (AHA)
The AHA measures the effectiveness with which a child with unilateral upper limb disabilities use their affected hand in the bimanual activity with a total raw score range between 22-88 points (the rating scale categories is: 4=effective, 3=somewhat effective, 2=ineffective, and 1=does not do). The higher score indicating higher ability.
Measured: Change from baseline (T0) AHA score to the end of the 3 weeks of treatment (T1), at 8 to 12 weeks (T2) and at 24 to 28 weeks (T3) follow up.
Secondary outcomes (4)
Change in Melbourne Assessment of Unilateral Upper Limb Function (MUUL)
MUUL is a measure of the unilateral upper limb function. It consists of 16 items that include: reaching, grasping, releasing, manipulating, which estimates 4 domains of movement quality (range, accuracy, fluidity, dexterity). A score from 0 to 3 or 4 is assigned for each domain. Higher scores are associated with better performances.
Measured: Change from baseline (T0) MUUL score to the end of the 3 weeks of treatment (T1), at 8 to 12 weeks (T2) and at 24 to 28 weeks (T3) follow up.
Change in Ability Hand Kids questionnaire (ABILHAND-Kids)
The ABILHAND-Kids is a measure of bimanual performance in activities of daily living.The scale measures a person's ability to manage daily activities that require the use of the upper limbs.The total score based on 21 activities. The parent is asked to rate his/her perception on the response scale as "Impossible", "Difficult" or "Easy" (0 = "Impossible", 1 = "Difficult" or 2 = "Easy").The total score based on 21 activities is then converted into a linear measure of manual ability (logits).
Measured: Change from baseline (T0) ABILHAND-Kids score to the end of the 3 weeks of treatment (T1), at 8 to 12 weeks (T2) and at 24 to 28 weeks (T3) follow up.
Change in Activities Scale for Kids-Performance Version (ASKp)
The ASKp measure physical function and disability in children with musculoskeletal disorders based on their perspective of what they have been doing at home, at school, and on the playground. ASKp is a child self-report questionnaire, which can be parent-reported if necessary. Scale ranges from 0 to 100 with higher scores representing more physical activity.
Measured: Change from baseline (T0) ASKp score to the end of the 3 weeks of treatment (T1), at 8 to 12 weeks (T2) and at 24 to 28 weeks (T3) follow up.
Change from baseline of functional magnetic resonance imaging (fMRI) analysis
fMRI action observation task
Measured: Baseline (T0), T1 (at the end of the 3 weeks of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2019
- Study start3 Dec 2019
- Primary completion16 Feb 2022
- Study completion16 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hemiplegic Cerebral PalsyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled experimental study, with 1:1 allocation ratio and two-armed blind assessment. Randomization will be stratified by age and level of HFC system to obtain two groups balanced with respect to the level of functional impairment of the upper limbs to be subjected to treatment in the two groups. Clinical evaluations will be performed before treatment (T0), at the end of treatment (T1), from 8 to 12 weeks after the end of treatment (T2) and finally, from 24 to 28 weeks after the end of treatment (T3). Evaluation by fMRI will be performed at T0 and T1.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Parma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leonardo Fogassi, PhD, Principal investigator, University of Parma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04088994
- Sponsor's protocol ID
- CEREBRALPALSYc1
- Status last verified
- Sep 2021
- First submitted
- 13 Jun 2019
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Derived data supporting the findings of this study will be available from the corresponding author upon reasonable request.
Publications
Errante A, Di Cesare G, Pinardi C, Fasano F, Sghedoni S, Costi S, Ferrari A, Fogassi L. Mirror Neuron System Activation in Children With Unilateral Cerebral Palsy During Observation of Actions Performed by a Pathological Model. Neurorehabil Neural Repair. 2019 Jun;33(6):419-431. doi: 10.1177/1545968319847964. Epub 2019 May 10.
PubMed 31072215Bressi B. Modulating the motor system by action observation in right hemiplegic cerebral palsy: an fMRI study. Nov. 2016, BSc Thesis in Physical Therapy. University of Modena and Reggio Emilia, Italy.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation of Hemiplegic Cerebral Palsy Children: Role of Motor Activity and Action Observation Therapy in the Recovery of the Affected Upper Limb
- ClinicalTrials.gov ID
- NCT04088994
- Acronym / sponsor ID
- CEREBRALPALSYc1
- Conditions
- Hemiplegic Cerebral Palsy, Motor Activity
- Keywords
- Hemiplegic Cerebral Palsy, Mirror neuron System, Action Observation, Rehabilitation, fMRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of ParmaUniversity, hospital or other
- Study start
- 3 Dec 2019 (actual)
- Primary completion
- 16 Feb 2022 (actual)
- Study completion
- 16 Feb 2022 (actual)
- First posted
- 13 Sep 2019 (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.
Recent evidence suggested that Action Observation Therapy (AOT), based on observation of actions followed by immediate reproduction, could be a useful rehabilitative strategy for promoting functional recovery of children affected by Unilateral Cerebral Palsy (UCP).
The AOT is based on the discovery of mirror neurons, a class of visuomotor neurons that are activated when the individual performs a targeted action, both when observing the same action performed by another individual.
An important assumption of AOT is that the mirror system, thanks to its visuomotor properties, is able to coordinate visual information with the observer's motor experience. Indeed, the actions outside the individual's behavioral repertoire are elaborated and categorized only on the basis of visual characteristics, without inducing any phenomenon of motor resonance in the observer's brain.
Therefore, given the deficiency of their motor repertoire, children affected by UCP could have a reduced activation of the mirror system during the observation of actions performed by healthy subjects. Nevertheless, this activation could increase during the observation of the same actions performed by a subject with similar motor strategies, due to a similar form of hemiplegia.
The present project is a randomized controlled clinical trial to verify the influence of the observed model on the effectiveness of AOT in the rehabilitation of the affected upper limb in children with UCP. In particular, the study will verify whether the rehabilitation through AOT based on a pathological model (improving the patient's current abilities) gives more results than AOT based on a typical (healthy) development model, as reported by all the documented researches in literature.
Furthermore, to investigate the functional reorganization of the sensorimotor system after rehabilitative treatment, a subgroup of participants will be subjected to a fMRI session (Functional Magnetic Resonance), to verify functional changes, comparing data before and after AOT.
Detailed description
The study will compare two rehabilitation models through AOT to assess feasibility and effectiveness. In the preliminary phase of the study a single rehabilitation treatment protocol will be planned, based on the observation and execution of unimanual and bimanual actions integrated in activities that are significant for the subject's age group. The recorded actions will be performed by a child with typical development and by two hemiplegic children:
- upper limb disability with grades between 4-5 according to House Functional Classification (HFC) system (corresponding to synergic hand of Ferrari and Cioni's Kinematic Hand Classification).
- upper limb disability with grades between 6-7 according to HFC system (corresponding to subfunctional hand of Ferrari and Cioni's Kinematic Hand Classification).
The participants (N. 26) randomly assigned to the experimental group will be subjected to the rehabilitation protocol through AOT based on the observation of the "Pathological Model". The model, while showing a manipulation strategy similar to that of the study participant, will show an improvement with respect to the patient's current abilities. The children randomly assigned to the control group will be subjected to the rehabilitation treatment protocol through AOT based on the "Typical developmental model".
Both experimental and control treatment will consist of a minimum of 10 hours (min. 10, max 15) for a period of 15 consecutive working days (3 weeks). Each video sequence will show a specific action repeated several times for 3 minutes. Subsequently, participants will be asked to perform the action observed with their hemiplegic upper limb or with both upper limbs for a maximum of 3 repetitions.
A subgroup of study participants (N. 8+8) from both groups will undergo two fMRI sessions, before and immediately after the AOT.
The fMRI session consists of two experimental tasks:
- action observation (functional session 1-2), in which patients will observe short videos in which actions are performed with the right hand from a subjective perspective.
- motor task (session 3), in which actions consist in reaching-grasping an object (a cube, a sphere or a cylinder) and putting it into boxes, placed on the right and on the left of the object.
The study consists of two experimental conditions:
- Observation of the paretic hand, in which the actions will be performed by another patient with UCP.
- Observation of the healthy hand, in which the action will be reproduced by a healthy model.
The aim of the study is to investigate the functional reorganization of sensorimotor system comparing functional activation before and after rehabilitation with AOT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled experimental study, with 1:1 allocation ratio and two-armed blind assessment. Randomization will be stratified by age and level of HFC system to obtain two groups balanced with respect to the level of functional impairment of the upper limbs to be subjected to treatment in the two groups. Clinical evaluations will be performed before treatment (T0), at the end of treatment (T1), from 8 to 12 weeks after the end of treatment (T2) and finally, from 24 to 28 weeks after the end of treatment (T3). Evaluation by fMRI will be performed at T0 and T1.
| Arm | Type | Receives |
|---|---|---|
| pathological model | Experimental | Other: AOT Pathological Model Experimental GroupThe children assigned to the experimental group will participate in a rehabilitative protocol based on the AOT observing unimanual and bimanual actions performed by a model with a similar manipulation strategy but improved with respect to the child's current abilities. |
| Healthy model | Active comparator | Other: AOT Healthy Model Control GroupThe children assigned to the control group will participate in a rehabilitative protocol based on the AOT observing unimanual and bimanual actions performed by a healthy model |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- confirmed diagnosis of UCP according to definition (MRI and clinical history)
- age 6-16 years at the time of recruitment;
- mild or moderate disability of the upper limb: score between 4 and 7 according to the House Functional Classification (HFC) system;
- sufficient cooperation and understanding to participate in the activities, according to the doctor/physiotherapist who is treating the child and to the neuropsychological evaluation.
Key exclusion criteria (8 listed)
- cognitive, visual or auditory impairments;
- history of seizures or seizures not well controlled by therapy;
- upper limb surgery within 8 months prior to enrollment;
- upper limb botulinum toxin injection (BoNT-A) within 6 months prior to enrollment.
- insufficient cooperation to participation in neuroimaging studies lasting about 30 minutes;
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 |
|---|---|---|
| AOT Pathological Model Experimental GroupAlso: Pathological ModelThe children will participate in a rehabilitation intervention based on the observation of unimanual and bimanual actions performed by a model with the same degree of motor impairment, but an improvement on the participant's current abilities. | Other | pathological model |
| AOT Healthy Model Control GroupAlso: Healthy ModelThe children assigned to the healthy group will participate in a rehabilitative protocol based on the AOT observing unimanual and bimanual actions performed by a healthy model | Other | Healthy model |
Primary outcome
Change in Assisting Hand Assessment (AHA)
Time frame: Change from baseline (T0) AHA score to the end of the 3 weeks of treatment (T1), at 8 to 12 weeks (T2) and at 24 to 28 weeks (T3) follow up.
The AHA measures the effectiveness with which a child with unilateral upper limb disabilities use their affected hand in the bimanual activity with a total raw score range between 22-88 points (the rating scale categories is: 4=effective, 3=somewhat effective, 2=ineffective, and 1=does not do). The higher score indicating higher ability.
4 secondary outcomes
Change in Melbourne Assessment of Unilateral Upper Limb Function (MUUL)
Time frame: Change from baseline (T0) MUUL score to the end of the 3 weeks of treatment (T1), at 8 to 12 weeks (T2) and at 24 to 28 weeks (T3) follow up.
Change in Ability Hand Kids questionnaire (ABILHAND-Kids)
Time frame: Change from baseline (T0) ABILHAND-Kids score to the end of the 3 weeks of treatment (T1), at 8 to 12 weeks (T2) and at 24 to 28 weeks (T3) follow up.
Change in Activities Scale for Kids-Performance Version (ASKp)
Time frame: Change from baseline (T0) ASKp score to the end of the 3 weeks of treatment (T1), at 8 to 12 weeks (T2) and at 24 to 28 weeks (T3) follow up.
Change from baseline of functional magnetic resonance imaging (fMRI) analysis
Time frame: Baseline (T0), T1 (at the end of the 3 weeks of treatment)
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 21 Jul 2022.
- Results publication: PubMed 31072215Errante A, Di Cesare G, Pinardi C, Fasano F, Sghedoni S, Costi S, Ferrari A, Fogassi L. Mirror Neuron System Activation in Children With Unilateral Cerebral Palsy During Observation of Actions Performed by a Pathological Model. Neurorehabil Neural Repair. 2019 Jun;33(6):419-431. doi: 10.1177/1545968319847964. Epub 2019 May 10.
- Results publicationBressi B. Modulating the motor system by action observation in right hemiplegic cerebral palsy: an fMRI study. Nov. 2016, BSc Thesis in Physical Therapy. University of Modena and Reggio Emilia, Italy.
- Individual participant dataSharing planned: No. Derived data supporting the findings of this study will be available from the corresponding author upon reasonable request.
Related trials for Hemiplegic Cerebral Palsy
Not yet recruiting
Effect of Robotic Gloves Training on Upper Limb Coordination, Selective Motor Control and Activities of Daily Living in Children With Hemiparetic Cerebral Palsy
Hemiplegic Cerebral Palsy
Not yet recruiting
Effects of Upper Extremity Physiotherapy and Home Exercises on Functional Outcomes in Individuals With Stroke
Stroke
Recruiting
Short-Term Effects of Manual Therapy Prior to Neuromotor Therapy in Children With Cerebral Palsy
Cerebral Palsy (CP), Unilateral Spastic Cerebral Palsy
Active, not recruiting
Virtual Reality Vs Postural Control Training in Children With Cerebral Palsy
Children With Hemiplegic cp
Recruiting
Neuro-MoD: Neuroplasticity With Motor Development
Perinatal Brain Injury
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.
Leonardo Fogassi, PhD principal investigator
University of Parma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AOT Pathological Model Experimental Group in people with Hemiplegic Cerebral Palsy and Motor Activity, run by University of Parma at 1 site in Italy.
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 8 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 21 Jul 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 Italy. 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?
Change in Assisting Hand Assessment (AHA) (time frame: Change from baseline (T0) AHA score to the end of the 3 weeks of treatment (T1), at 8 to 12 weeks (T2) and at 24 to 28 weeks (T3) follow up.). 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 NCT04088994, which also lists 2 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 21 Jul 2022.