Ataxic Cerebral PalsyNCT07291128
Effects of VOJTA Technique on Ataxic Cerebral Palsy.
A study testing VOJTA and Conventional Physical Therapy in people with Ataxic Cerebral Palsy, run by Lahore University of Biological and Applied Sciences at 1 site in Pakistan.
Trial summary
Ataxic cerebral palsy (CP) is the least common subtype of CP and it is primarily caused by cerebellar damage that results in hypotonia, impaired balance, poor coordination, tremors, wide-based gait, and significant difficulties in trunk stability and uncontrolled movements. Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Ataxic Cerebral Palsy
- What is being tested?
- VOJTA and Conventional Physical Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 8 Dec 2025to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Both male and female participants would be included
- Children diagnosed with ataxic cerebral palsy.
- Age range of participants will be 2 to 6 years old.
- Participants included will be at level 2 on gross motor function classification scale.
- Participants included will have ATNR reflex.
- Stable medical condition for the past three months with no hospitalizations.
Who cannot join
- Presence of severe comorbidities i.e. neurological or orthopedic conditions.
- Patients having significant cognitive deficits
- Down syndrome, hydrocephalus, epilepsy, autism and medically ill children
- Children with visual or auditory deficits affecting postural control and balance assessment.
- Ongoing pharmacological treatment (e.g., muscle relaxants or antiepileptic) likely to influence muscle tone or motor function during the study period
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Salwa Atta Salwa, supervisor contact
Pakistan1 site, 1 recruiting
- Recruiting
Department of Physical Therapy
Lahore, Punjab Province, 33351
About this study
Official title: Effects of VOJTA Technique on Muscle Tone, Gross Motor Function and Balance on Ataxic Cerebral Palsy.
Ataxic cerebral palsy (CP) is the least common subtype of CP and it is primarily caused by cerebellar damage that results in hypotonia, impaired balance, poor coordination, tremors, wide-based gait, and significant difficulties in trunk stability and uncontrolled movements. These impairments greatly affect functional mobility and independence in life. This randomized controlled trial aims to evaluate the effects of VOJTA therapy on muscle tone, gross motor function, and postural control in children with ataxic CP aged 2-6 years. VOJTA therapy is based on reflex locomotion, which activates innate central motor programs by stimulating specific pressure zones in defined positions, potentially improving postural alignment and coordinated muscle activation. A total of 40 children will be randomly assigned to either the VOJTA therapy group or a conventional physiotherapy group. Both groups will receive total of 5 sessions per week for 8 weeks and the Outcomes will be measured at baseline, 4 weeks, and 8 weeks using the Modified Ashworth Scale (MAS) for muscle tone, Gross Motor Function Measure (GMFM-88) for gross motor function and Pediatric balance scale for for balance. This study hypothesizes that VOJTA therapy will produce greater improvements in muscle tone, gross motor function and balance as compared to conventional physical therapy techniques. Findings may support evidence-based rehabilitation strategies for ataxic CP and contribute to improved functional independence and quality of life in this understudied population.
Read the detailed description
Cerebral palsy (CP) is a lifetime neurological condition caused by an early injury to the brain that cannot change over time, and although the brain injury itself is non-progressive, the motor problems can be different as they grow CP really affects the whole body movement, and the things that are performed by the body's muscles like, posture, coordination, muscle tone, and balance, In other cases, however, sensory processing challenges are present along with these and the child may experience delayed motor development. Among the different types of CP, ataxic cerebral palsy is the one that occurs least often, with an incidence of only around 5-10% of total CP cases. Although it is a type of cerebral palsy that is complex and therefore, more debilitating. The defining feature of ataxic CP which is mainly due to the cerebellar part of the brain being affected and motor commands of the body being uncoordinated and imprecise. Children affected by this type of CP usually have hypotonia, tremors when trying to perform a task, dysmetria, are unsteady or walk with feet far apart, have poor control of the upper body and reach motor skills later than the typical child, therefore every movement that they try to make, including the most basic ones like sitting, reaching, standing or walking, are very hard. Especially, the very important motor and communication functions of the hands, arms, and legs are affected. But although all of these problems point to a very serious form of CP, ataxic CP has so far gotten far less research attention than spastic CP and consequently, less clinical evidence-based guidance that is tailored specifically to this subtype. Most of the time, children that suffer from ataxic CP are subjected to traditional physiotherapy methods such as Neurodevelopmental Therapy, Bobath techniques, balance training, sensory integration, or strengthening exercises; however, these methods are only moderately successful as they do not directly address the specific coordination and postural control difficulties that are related to cerebellar dysfunction, thus, they do not offer any substantial change in the quality of life of the affected children. Since then the gap has become wider and that is why there is more and more interest in the neurophysiological methods that stimulate and activate the central motor pathways that are responsible for posture and movement. VOJTA therapy, which is also known as reflex locomotion therapy, provides a different method by the activation of movements that are automatic and innate through the specific stimulation of pressure that is applied while the child is in the defined postures. The treatment is thought to activate both spinal and supraspinal pathways thus increasing the muscle activation in the trunk, improving postural control, and causing the brain to generate new pathways. Studies on children suffering from cerebral palsy with spastic condition have reported better results in the areas of gross motor function, trunk stability, and early motor development. Neuroimaging has shown the activation of sensorimotor cortical areas during the stimulation of VOJTA. However, there is not enough research on the VOJTA therapy application for children with ataxic CP although they experience severe coordination and balance problems. This research intends to support filling this important gap by analyzing the VOJTA therapy effect on muscle tonicity, gross motor function, and balance in children aged 2-6 years with ataxic CP. Out of forty participants, some will be placed in the VOJTA therapy group while others will be put in the conventional physiotherapy group and the treatment will be done five times per week for eight weeks. The evaluation of the outcomes will be done at the beginning, after four weeks, and after eight weeks through the Modified Ashworth Scale for muscle tone, the Gross Motor Function Measure for motor performance, and the Pediatric Balance Scale for balance. The hypothesis of the study is that VOJTA therapy will bring about a more significant reduction of the problem in muscle tone, balance, and gross motor functions than conventional physiotherapy. This study, by concentrating on one of the least studied types of CP, has the capacity to help reshape clinical practice, enhance rehabilitation techniques better, and lead to less standard and more evidence-based care for the child with CP.
- Conditions
- Ataxic Cerebral Palsy
- Being tested
- VOJTA, Conventional Physical Therapy
- Keywords
- vojta, muscle tone, ataxic cerebral palsy, gross motor function, balance
- Medical subject headings
- Cerebral Palsy, Ataxic, Autosomal Recessive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VOJTABehavioural
VOJTA therapy will be administered by a physiotherapist. The intervention involves mechanical stimulation of defined reflex zones located on the trunk and limbs while the child is in prone, supine, or side-lying postures. Stimulation elicits automatic reflex creeping or reflex rolling patterns that enhance trunk activation, postural control, coordination, and normalization of muscle tone. Treatment follows the standardized VOJTA protocol, applying precise direction, pressure, and duration of stimulation. The frequency will be 5 sessions per week for 8 weeks with duration of 30 minutes.
Conventional Physical TherapyBehavioural
Conventional physiotherapy includes evidence-based approaches commonly applied for cerebral palsy rehabilitation. This may include NDT/Bobath principles, balance and postural stability exercises, core strengthening, stretching, functional mobility training, and sensory-motor facilitation. No VOJTA stimulation will be used. All participants follow a standardized treatment protocol to ensure consistency. The frequency will be 5 sessions per week for 8 weeks with duration of 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Group 1/ VOJTA | Experimental | Participants in this arm will receive VOJTA reflex locomotion therapy, which involves activating innate locomotor patterns through manual stimulation of specific pressure zones while the child is positioned in standardized postures. This arm examines the effectiveness of VOJTA therapy in improving muscle tone, balance, and gross motor function in children with ataxic cerebral palsy Receives: Behavioral: VOJTA |
| Group 2 / Conventional Physical Therapy | Active comparator | Participants in this arm will receive routine conventional physiotherapy commonly used for cerebral palsy rehabilitation. This includes Neurodevelopmental Therapy (NDT/Bobath-based methods), balance training, core strengthening, stretching, and functional task-oriented exercises. This arm serves as the comparison group. Receives: Behavioral: Conventional Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Ashworth Scale (MAS)
Muscle tone will be evaluated using the Modified Ashworth Scale, which measures resistance during passive movement to assess tone abnormalities. Scores range from 0 to 4, with higher scores indicating increased resistance or greater tone abnormality. Improvement is defined as a reduction in MAS scores or normalization of tone patterns following the intervention period.
Measured: Baseline, 4 weeks, 8 weeks
Gross Motor Function Measure-88 (GMFM-88)
Gross motor function will be assessed using the GMFM-88, a validated observational measure designed to evaluate changes in motor skills across five domains (lying/rolling; sitting; crawling/kneeling; standing; walking/running/jumping). Total and domain-specific scores will be analyzed. Improvement is defined as an increase in GMFM-88 scores after the intervention.
Measured: Baseline, 4 weeks, 8 weeks
Pediatric Balance Scale (PBS)
Balance performance will be measured using the Pediatric Balance Scale, which includes 14 tasks assessing static and dynamic balance in functional positions. Scores range from 0 to 56, with higher scores representing better balance control. Improvement is defined as an increase in PBS scores following treatment.
Measured: Baseline, 4 weeks, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start8 Dec 2025
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
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 Ataxic Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Lahore University of Biological and Applied SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After recruitment of participants into study they will be allocated to their respective groups utilizing the online randomizer tool.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07291128
- Sponsor's protocol ID
- UBAS/ERB/FoRS/25/043 Fareeha
- Status last verified
- Dec 2025
- First submitted
- 5 Dec 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ha SY, Sung YH. Effects of Vojta approach on diaphragm movement in children with spastic cerebral palsy. J Exerc Rehabil. 2018 Dec 27;14(6):1005-1009. doi: 10.12965/jer.1836498.249. eCollection 2018 Dec.
PubMed 30656162Sanchez-Gonzalez JL, Sanz-Esteban I, Menendez-Pardinas M, Navarro-Lopez V, Sanz-Mengibar JM. Critical review of the evidence for Vojta Therapy: a systematic review and meta-analysis. Front Neurol. 2024 Apr 22;15:1391448. doi: 10.3389/fneur.2024.1391448. eCollection 2024.
PubMed 38711552
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of VOJTA Technique on Muscle Tone, Gross Motor Function and Balance on Ataxic Cerebral Palsy.
- ClinicalTrials.gov ID
- NCT07291128
- Acronym / sponsor ID
- UBAS/ERB/FoRS/25/043 Fareeha
- Conditions
- Ataxic Cerebral Palsy
- Keywords
- vojta, muscle tone, ataxic cerebral palsy, gross motor function, balance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Lahore University of Biological and Applied SciencesUniversity, hospital or other
- Study start
- 8 Dec 2025 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 18 Dec 2025 (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.
Ataxic cerebral palsy (CP) is the least common subtype of CP and it is primarily caused by cerebellar damage that results in hypotonia, impaired balance, poor coordination, tremors, wide-based gait, and significant difficulties in trunk stability and uncontrolled movements. These impairments greatly affect functional mobility and independence in life. This randomized controlled trial aims to evaluate the effects of VOJTA therapy on muscle tone, gross motor function, and postural control in children with ataxic CP aged 2-6 years. VOJTA therapy is based on reflex locomotion, which activates innate central motor programs by stimulating specific pressure zones in defined positions, potentially improving postural alignment and coordinated muscle activation. A total of 40 children will be randomly assigned to either the VOJTA therapy group or a conventional physiotherapy group. Both groups will receive total of 5 sessions per week for 8 weeks and the Outcomes will be measured at baseline, 4 weeks, and 8 weeks using the Modified Ashworth Scale (MAS) for muscle tone, Gross Motor Function Measure (GMFM-88) for gross motor function and Pediatric balance scale for for balance. This study hypothesizes that VOJTA therapy will produce greater improvements in muscle tone, gross motor function and balance as compared to conventional physical therapy techniques. Findings may support evidence-based rehabilitation strategies for ataxic CP and contribute to improved functional independence and quality of life in this understudied population.
Detailed description
Cerebral palsy (CP) is a lifetime neurological condition caused by an early injury to the brain that cannot change over time, and although the brain injury itself is non-progressive, the motor problems can be different as they grow CP really affects the whole body movement, and the things that are performed by the body's muscles like, posture, coordination, muscle tone, and balance, In other cases, however, sensory processing challenges are present along with these and the child may experience delayed motor development. Among the different types of CP, ataxic cerebral palsy is the one that occurs least often, with an incidence of only around 5-10% of total CP cases. Although it is a type of cerebral palsy that is complex and therefore, more debilitating. The defining feature of ataxic CP which is mainly due to the cerebellar part of the brain being affected and motor commands of the body being uncoordinated and imprecise. Children affected by this type of CP usually have hypotonia, tremors when trying to perform a task, dysmetria, are unsteady or walk with feet far apart, have poor control of the upper body and reach motor skills later than the typical child, therefore every movement that they try to make, including the most basic ones like sitting, reaching, standing or walking, are very hard. Especially, the very important motor and communication functions of the hands, arms, and legs are affected. But although all of these problems point to a very serious form of CP, ataxic CP has so far gotten far less research attention than spastic CP and consequently, less clinical evidence-based guidance that is tailored specifically to this subtype. Most of the time, children that suffer from ataxic CP are subjected to traditional physiotherapy methods such as Neurodevelopmental Therapy, Bobath techniques, balance training, sensory integration, or strengthening exercises; however, these methods are only moderately successful as they do not directly address the specific coordination and postural control difficulties that are related to cerebellar dysfunction, thus, they do not offer any substantial change in the quality of life of the affected children. Since then the gap has become wider and that is why there is more and more interest in the neurophysiological methods that stimulate and activate the central motor pathways that are responsible for posture and movement. VOJTA therapy, which is also known as reflex locomotion therapy, provides a different method by the activation of movements that are automatic and innate through the specific stimulation of pressure that is applied while the child is in the defined postures. The treatment is thought to activate both spinal and supraspinal pathways thus increasing the muscle activation in the trunk, improving postural control, and causing the brain to generate new pathways. Studies on children suffering from cerebral palsy with spastic condition have reported better results in the areas of gross motor function, trunk stability, and early motor development. Neuroimaging has shown the activation of sensorimotor cortical areas during the stimulation of VOJTA. However, there is not enough research on the VOJTA therapy application for children with ataxic CP although they experience severe coordination and balance problems. This research intends to support filling this important gap by analyzing the VOJTA therapy effect on muscle tonicity, gross motor function, and balance in children aged 2-6 years with ataxic CP. Out of forty participants, some will be placed in the VOJTA therapy group while others will be put in the conventional physiotherapy group and the treatment will be done five times per week for eight weeks. The evaluation of the outcomes will be done at the beginning, after four weeks, and after eight weeks through the Modified Ashworth Scale for muscle tone, the Gross Motor Function Measure for motor performance, and the Pediatric Balance Scale for balance. The hypothesis of the study is that VOJTA therapy will bring about a more significant reduction of the problem in muscle tone, balance, and gross motor functions than conventional physiotherapy. This study, by concentrating on one of the least studied types of CP, has the capacity to help reshape clinical practice, enhance rehabilitation techniques better, and lead to less standard and more evidence-based care for the child with CP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- After recruitment of participants into study they will be allocated to their respective groups utilizing the online randomizer tool.
| Arm | Type | Receives |
|---|---|---|
| Group 1/ VOJTA | Experimental | Behavioral: VOJTAParticipants in this arm will receive VOJTA reflex locomotion therapy, which involves activating innate locomotor patterns through manual stimulation of specific pressure zones while the child is positioned in standardized postures. This arm examines the effectiveness of VOJTA therapy in improving muscle tone, balance, and gross motor function in children with ataxic cerebral palsy |
| Group 2 / Conventional Physical Therapy | Active comparator | Behavioral: Conventional Physical TherapyParticipants in this arm will receive routine conventional physiotherapy commonly used for cerebral palsy rehabilitation. This includes Neurodevelopmental Therapy (NDT/Bobath-based methods), balance training, core strengthening, stretching, and functional task-oriented exercises. This arm serves as the comparison group. |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Both male and female participants would be included
- Children diagnosed with ataxic cerebral palsy.
- Age range of participants will be 2 to 6 years old.
- Participants included will be at level 2 on gross motor function classification scale.
- Participants included will have ATNR reflex.
Key exclusion criteria (5 listed)
- Presence of severe comorbidities i.e. neurological or orthopedic conditions.
- Patients having significant cognitive deficits
- Down syndrome, hydrocephalus, epilepsy, autism and medically ill children
- Children with visual or auditory deficits affecting postural control and balance assessment.
- Ongoing pharmacological treatment (e.g., muscle relaxants or antiepileptic) likely to influence muscle tone or motor function during the study period
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 |
|---|---|---|
| VOJTAVOJTA therapy will be administered by a physiotherapist. The intervention involves mechanical stimulation of defined reflex zones located on the trunk and limbs while the child is in prone, supine, or side-lying postures. Stimulation elicits automatic reflex creeping or reflex rolling patterns that enhance trunk activation, postural control, coordination, and normalization of muscle tone. Treatment follows the standardized VOJTA protocol, applying precise direction, pressure, and duration of stimulation. The frequency will be 5 sessions per week for 8 weeks with duration of 30 minutes. | Behavioural | Group 1/ VOJTA |
| Conventional Physical TherapyConventional physiotherapy includes evidence-based approaches commonly applied for cerebral palsy rehabilitation. This may include NDT/Bobath principles, balance and postural stability exercises, core strengthening, stretching, functional mobility training, and sensory-motor facilitation. No VOJTA stimulation will be used. All participants follow a standardized treatment protocol to ensure consistency. The frequency will be 5 sessions per week for 8 weeks with duration of 30 minutes. | Behavioural | Group 2 / Conventional Physical Therapy |
Primary outcome
Modified Ashworth Scale (MAS)
Time frame: Baseline, 4 weeks, 8 weeks
Muscle tone will be evaluated using the Modified Ashworth Scale, which measures resistance during passive movement to assess tone abnormalities. Scores range from 0 to 4, with higher scores indicating increased resistance or greater tone abnormality. Improvement is defined as a reduction in MAS scores or normalization of tone patterns following the intervention period.
Gross Motor Function Measure-88 (GMFM-88)
Time frame: Baseline, 4 weeks, 8 weeks
Gross motor function will be assessed using the GMFM-88, a validated observational measure designed to evaluate changes in motor skills across five domains (lying/rolling; sitting; crawling/kneeling; standing; walking/running/jumping). Total and domain-specific scores will be analyzed. Improvement is defined as an increase in GMFM-88 scores after the intervention.
Pediatric Balance Scale (PBS)
Time frame: Baseline, 4 weeks, 8 weeks
Balance performance will be measured using the Pediatric Balance Scale, which includes 14 tasks assessing static and dynamic balance in functional positions. Scores range from 0 to 56, with higher scores representing better balance control. Improvement is defined as an increase in PBS scores following treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Results publication: PubMed 30656162Ha SY, Sung YH. Effects of Vojta approach on diaphragm movement in children with spastic cerebral palsy. J Exerc Rehabil. 2018 Dec 27;14(6):1005-1009. doi: 10.12965/jer.1836498.249. eCollection 2018 Dec.
- Results publication: PubMed 38711552Sanchez-Gonzalez JL, Sanz-Esteban I, Menendez-Pardinas M, Navarro-Lopez V, Sanz-Mengibar JM. Critical review of the evidence for Vojta Therapy: a systematic review and meta-analysis. Front Neurol. 2024 Apr 22;15:1391448. doi: 10.3389/fneur.2024.1391448. eCollection 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.
Salwa Atta Salwa, supervisor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VOJTA and Conventional Physical Therapy in people with Ataxic Cerebral Palsy, run by Lahore University of Biological and Applied Sciences at 1 site in Pakistan.
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 6 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: looking for participants now, as of the sponsor's last update on 30 Dec 2025. 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fareeha Ijaz fareeha, Masters (+923201014615, Fareehaijaz2018@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Ashworth Scale (MAS) (time frame: Baseline, 4 weeks, 8 weeks). 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?
On the ClinicalTrials.gov record for NCT07291128, 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 30 Dec 2025.