Cerebral Palsy (CP)NCT07072416
Aquatic Based Exercises Versus Mirror Therapy on Hand Dexterity and Strength in Hemiplegic Child
A study testing Aquatic Exercise, Mirror Therapy and Designed physical therapy program. in people with Cerebral Palsy (CP) and Hemiplegia and Hemiparesis, run by Alaa Noureldeen Kora at 1 site in Egypt.
Trial summary
Cerebral palsy (CP) is a neurologic disorder that affects motor function, balance, and posture, and spastic hemiplegia is found in about one-third of persons with CP and often leads to devastating upper limb disability. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Cerebral Palsy (CP), Hemiplegia and Hemiparesis
- What is being tested?
- Aquatic Exercise, Mirror Therapy and Designed physical therapy program.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2025to 30 Sep 2025
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with Hemiplegic cerebral palsy
- Children with mild to moderate spasticity of wrist muscles spasticity will range between (0-4) score according to Modified Ashworth Scale.
- Children will be able to follow the instructions.
- Children without any genetic disorders.
Who cannot join
- Cognitive impairment.
- Unilateral neglect disorders.
- Orthopedic dysfunction.
- Visual impairment.
- Verbal impairment.
- Open wound or infection
Show all 9Show fewer
- Fixed contractures.
- Previous limb surgeries within 6 months.
- Resting angina.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Damanhur Medical National Institute Hospital
Damanhur, Beheira, 5844152
About this study
Cerebral palsy (CP) is a neurologic disorder that affects motor function, balance, and posture, and spastic hemiplegia is found in about one-third of persons with CP and often leads to devastating upper limb disability. Rehabilitation interventions such as aquatic therapy and mirror therapy are commonly utilized to improve motor function and functional independence. Water therapy takes advantage of water resistance and buoyancy to relax tightened muscles, promote gross motor function, and increase muscle endurance and strength with studies showing significant improvements in motor skills as well as a reduction in spasticity in CP children, especially hemiplegic children. Water therapy can also be more enjoyable and convenient for kids, but safety has to be considered. Mirror therapy does utilize visual feedback, but to cause the movement in the paralyzed limb, and can increase hand dexterity and grip strength by stimulating the neural pathways through the illusion of movement. Although aquatic therapy has shown well-defined advantages in motor functioning and muscle tone, comparison of the efficacy of aquatic exercises and mirror therapy for hand dexterity and grip strength in hemiplegic CP has been limited, and further studies are indicated to establish their relative merits and potential complementary uses.
Read the detailed description
Cerebral palsy (CP) is a neurological impairment of motor disorder, balance, movement disorder, and postural deformities that appear during infancy and early childhood, although muscle tone and posture related abnormalities becomes more prominent in later years . Globally CP occurs 1.5 to more than 4 per 1000 live births.
One of the types of CP is spastic hemiplegia, known as half-body paralysis and the prevalence is about 35.1% of all children with CP . Upper limb function impairment is a common and disability consequence of problems in reaching, pointing, and taking, releasing and manipulating objects . The ability to reach and grasp things is one of the basic tasks in activities of daily living.
Multiple approaches in the physical therapy are being used in the rehabilitation of CP such as stretching, strengthening, Neuro-developmental technique (NDT), motor relearning programs in reducing the spasticity and improving functional level in CP (Dimitrijević et al., 2012). During current practices, primary focus on improving the functional independency and motor skills, thus aquatic therapy is good approach in this regard (Declerck et al., 2013).
Furthermore, hydrotherapy is effective treatment mode due to buoyancy and hydrostatic properties of water. Buoyancy force is equal to the weight of the fluid displaced by the object. According the hydrotherapy is an effective treatment option in CP due to its thermal and mechanical effects.
Thermal effects relax the muscle and facilitates in reducing the spasticity while mechanical effects of water are sufficient in reducing the effect of gravity and minimizing the joint loading, furthermore, water provides enjoyable environment to perform multiple functional activities for cerebral palsy (Getz et al., 2012). Exercises in the pool are always performed at the temperature of 33°- 35oC that is essential in reducing the spasticity by relaxing the muscles (Adar et al., 2017). Besides these effects hydrotherapy has effects on strengthening the muscles and endurance since water creates resistance during walking that strengthens the muscles (Khalaji et al., 2017). Activities performed in water are easier and effective as compared to the land but it has a major safety issue that should be identified before the start of exercises for the better results (Adar et al., 2017). Hydrotherapy has several positive effects in the management of spasticity, joint range of motion and improving balance in CP. Since the aquatic exercise reduces spasticity thus has potential effects in improving the gross motor functions among CP.
Among non-invasive approaches, mirror therapy is a relatively new approach that focuses on visual stimulation and the movements of limbs without damage. The reflection of the healthy limb movement in the mirror is thought the affected limb is moving naturally (Fukumura et al., 2007). In this method, the patient places his hands on the two sides of the mirror. Thus, the patient understands the reflection of his healthy hand in the mirror as his affected hand (Mc Cabe et al., 2008).
Statement of problem:
Is there difference between effects of aquatic based exercises and mirror therapy on hand dexterity and hand grip strength in children with hemiplegic cerebral palsy?
Purpose of study:
The purpose of this study is:
- To investigate the effect of aquatic based exercises and mirror therapy on hand dexterity and hand grip strength in children with hemiplegic cerebral palsy
- To investigate the correlations between the effects of aquatic based exercises, mirror therapy and control group on hand dexterity and hand grip strength in children with hemiplegic cerebral palsy.
- Conditions
- Cerebral Palsy (CP), Hemiplegia and Hemiparesis
- Being tested
- Aquatic Exercise, Mirror Therapy, Designed physical therapy program.
- Keywords
- Aquatic Based Exercises, Hemiplegic Child, Hand Dexterity, Mirror Therapy, Hand Strenght, Cerebral Palsy
- Medical subject headings
- Cerebral Palsy, Hemiplegia, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aquatic ExerciseOther
Aquatic exercise or hydrotherapy, involving the performance of physical exercise in water, has been determined to have an assortment of beneficial health impacts on healthy individuals and those with chronic diseases. Aquatic exercise has been determined to enhance strength, balance, flexibility, and the quality of life, particularly among groups like postmenopausal women, patients with osteoarthritis, Parkinson's disease, and type 2 diabetes
Mirror TherapyOther
Mirror therapy is a type of rehabilitation where visual feedback is employed to induce movement and recovery in an affected limb by asking the patients to observe the reflection of their healthy limb in a mirror, giving the illusion that both limbs are moving normally.
Designed physical therapy program.Other
The program will start with 10 minutes of poolside exercises including warming up, active range of motion and stretching followed by 20 minutes of aquatic exercise in the pool. The pool session consists of 20 minutes of active range of motion, stretching and strengthening exercises
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Aquatic Therapy | Experimental | Children in Group A will receive aquatic based exercises and a designed physical therapy program Receives: Other: Aquatic Exercise; Other: Designed physical therapy program. |
| Group 2: Mirror Therapy | Experimental | Group B will receive mirror therapy and a designed physical therapy program Receives: Other: Mirror Therapy; Other: Designed physical therapy program. |
| Group 3: Control Group | Other | Control Group (C) will receive a designed physical therapy program. Receives: Other: Designed physical therapy program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Box and Block Test: It was used to assess gross manual dexterity
The Box and Block Test (BBT) is a widely used test to evaluate gross manual dexterity by rehabilitation centers and occupational therapy clinics. The individual has to move as many blocks as possible from one of the compartments of a box to the other in a given time period, usually one minute, using one hand at a time. The BBT is valued for simplicity, ease of use, and strong reliability and validity across the lifespan, and in clinical populations like children, adults, and those with neurological or musculoskeletal disorder
Measured: 3 Months
Hand held dynamometer to assess hand grip strength.
A popular, trustworthy, and legitimate tool for evaluating hand grip strength-a crucial sign of general muscle function and health-is a hand-held dynamometer.
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start1 May 2025
- Primary completion30 Aug 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cerebral Palsy (CP)Studies 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 Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alaa Noureldeen Kora
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alaa Noureldeen Kora, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07072416
- Sponsor's protocol ID
- P.T.REC/012/005354
- Status last verified
- Jul 2025
- First submitted
- 9 Jul 2025
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It will provided only upon reasonable request
Publications
Adar S, Dundar U, Demirdal US, Ulasli AM, Toktas H, Solak O. The effect of aquatic exercise on spasticity, quality of life, and motor function in cerebral palsy. Turk J Phys Med Rehabil. 2017 Aug 14;63(3):239-248. doi: 10.5606/tftrd.2017.280. eCollection 2017 Jun.
PubMed 31453460Roostaei M, Baharlouei H, Azadi H, Fragala-Pinkham MA. Effects of Aquatic Intervention on Gross Motor Skills in Children with Cerebral Palsy: A Systematic Review. Phys Occup Ther Pediatr. 2017 Oct 20;37(5):496-515. doi: 10.1080/01942638.2016.1247938. Epub 2016 Dec 14.
PubMed 27967298El-Shamy SM. Effects of Antigravity Treadmill Training on Gait, Balance, and Fall Risk in Children With Diplegic Cerebral Palsy. Am J Phys Med Rehabil. 2017 Nov;96(11):809-815. doi: 10.1097/PHM.0000000000000752.
PubMed 28410250Lai CJ, Liu WY, Yang TF, Chen CL, Wu CY, Chan RC. Pediatric aquatic therapy on motor function and enjoyment in children diagnosed with cerebral palsy of various motor severities. J Child Neurol. 2015 Feb;30(2):200-8. doi: 10.1177/0883073814535491. Epub 2014 Jun 5.
PubMed 24907137Ryu K, Ali A, Kwon M, Lee C, Kim Y, Lee G, Kim J. Effects of assisted aquatic movement and horseback riding therapies on emotion and brain activation in patients with cerebral palsy. J Phys Ther Sci. 2016 Dec;28(12):3283-3287. doi: 10.1589/jpts.28.3283. Epub 2016 Dec 27.
PubMed 28174435Stavsky M, Mor O, Mastrolia SA, Greenbaum S, Than NG, Erez O. Cerebral Palsy-Trends in Epidemiology and Recent Development in Prenatal Mechanisms of Disease, Treatment, and Prevention. Front Pediatr. 2017 Feb 13;5:21. doi: 10.3389/fped.2017.00021. eCollection 2017.
PubMed 28243583
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aquatic Based Exercises Versus Mirror Therapy on Hand Dexterity and Strength in Hemiplegic Child
- ClinicalTrials.gov ID
- NCT07072416
- Acronym / sponsor ID
- P.T.REC/012/005354
- Conditions
- Cerebral Palsy (CP), Hemiplegia and Hemiparesis
- Keywords
- Aquatic Based Exercises, Hemiplegic Child, Hand Dexterity, Mirror Therapy, Hand Strenght, Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Alaa Noureldeen KoraUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 18 Jul 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.
Cerebral palsy (CP) is a neurologic disorder that affects motor function, balance, and posture, and spastic hemiplegia is found in about one-third of persons with CP and often leads to devastating upper limb disability. Rehabilitation interventions such as aquatic therapy and mirror therapy are commonly utilized to improve motor function and functional independence. Water therapy takes advantage of water resistance and buoyancy to relax tightened muscles, promote gross motor function, and increase muscle endurance and strength with studies showing significant improvements in motor skills as well as a reduction in spasticity in CP children, especially hemiplegic children. Water therapy can also be more enjoyable and convenient for kids, but safety has to be considered. Mirror therapy does utilize visual feedback, but to cause the movement in the paralyzed limb, and can increase hand dexterity and grip strength by stimulating the neural pathways through the illusion of movement. Although aquatic therapy has shown well-defined advantages in motor functioning and muscle tone, comparison of the efficacy of aquatic exercises and mirror therapy for hand dexterity and grip strength in hemiplegic CP has been limited, and further studies are indicated to establish their relative merits and potential complementary uses.
Detailed description
Cerebral palsy (CP) is a neurological impairment of motor disorder, balance, movement disorder, and postural deformities that appear during infancy and early childhood, although muscle tone and posture related abnormalities becomes more prominent in later years . Globally CP occurs 1.5 to more than 4 per 1000 live births.
One of the types of CP is spastic hemiplegia, known as half-body paralysis and the prevalence is about 35.1% of all children with CP . Upper limb function impairment is a common and disability consequence of problems in reaching, pointing, and taking, releasing and manipulating objects . The ability to reach and grasp things is one of the basic tasks in activities of daily living.
Multiple approaches in the physical therapy are being used in the rehabilitation of CP such as stretching, strengthening, Neuro-developmental technique (NDT), motor relearning programs in reducing the spasticity and improving functional level in CP (Dimitrijević et al., 2012). During current practices, primary focus on improving the functional independency and motor skills, thus aquatic therapy is good approach in this regard (Declerck et al., 2013).
Furthermore, hydrotherapy is effective treatment mode due to buoyancy and hydrostatic properties of water. Buoyancy force is equal to the weight of the fluid displaced by the object. According the hydrotherapy is an effective treatment option in CP due to its thermal and mechanical effects.
Thermal effects relax the muscle and facilitates in reducing the spasticity while mechanical effects of water are sufficient in reducing the effect of gravity and minimizing the joint loading, furthermore, water provides enjoyable environment to perform multiple functional activities for cerebral palsy (Getz et al., 2012). Exercises in the pool are always performed at the temperature of 33°- 35oC that is essential in reducing the spasticity by relaxing the muscles (Adar et al., 2017). Besides these effects hydrotherapy has effects on strengthening the muscles and endurance since water creates resistance during walking that strengthens the muscles (Khalaji et al., 2017). Activities performed in water are easier and effective as compared to the land but it has a major safety issue that should be identified before the start of exercises for the better results (Adar et al., 2017). Hydrotherapy has several positive effects in the management of spasticity, joint range of motion and improving balance in CP. Since the aquatic exercise reduces spasticity thus has potential effects in improving the gross motor functions among CP.
Among non-invasive approaches, mirror therapy is a relatively new approach that focuses on visual stimulation and the movements of limbs without damage. The reflection of the healthy limb movement in the mirror is thought the affected limb is moving naturally (Fukumura et al., 2007). In this method, the patient places his hands on the two sides of the mirror. Thus, the patient understands the reflection of his healthy hand in the mirror as his affected hand (Mc Cabe et al., 2008).
Statement of problem:
Is there difference between effects of aquatic based exercises and mirror therapy on hand dexterity and hand grip strength in children with hemiplegic cerebral palsy?
Purpose of study:
The purpose of this study is:
- To investigate the effect of aquatic based exercises and mirror therapy on hand dexterity and hand grip strength in children with hemiplegic cerebral palsy
- To investigate the correlations between the effects of aquatic based exercises, mirror therapy and control group on hand dexterity and hand grip strength in children with hemiplegic cerebral palsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Group 1: Aquatic Therapy | Experimental | Other: Aquatic Exercise, Other: Designed physical therapy program.Children in Group A will receive aquatic based exercises and a designed physical therapy program |
| Group 2: Mirror Therapy | Experimental | Other: Mirror Therapy, Other: Designed physical therapy program.Group B will receive mirror therapy and a designed physical therapy program |
| Group 3: Control Group | Other | Other: Designed physical therapy program.Control Group (C) will receive a designed physical therapy program. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children with Hemiplegic cerebral palsy
- Children with mild to moderate spasticity of wrist muscles spasticity will range between (0-4) score according to Modified Ashworth Scale.
- Children will be able to follow the instructions.
- Children without any genetic disorders.
Key exclusion criteria (9 listed)
- Cognitive impairment.
- Unilateral neglect disorders.
- Orthopedic dysfunction.
- Visual impairment.
- Verbal impairment.
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 |
|---|---|---|
| Aquatic ExerciseAquatic exercise or hydrotherapy, involving the performance of physical exercise in water, has been determined to have an assortment of beneficial health impacts on healthy individuals and those with chronic diseases. Aquatic exercise has been determined to enhance strength, balance, flexibility, and the quality of life, particularly among groups like postmenopausal women, patients with osteoarthritis, Parkinson's disease, and type 2 diabetes | Other | Group 1: Aquatic Therapy |
| Mirror TherapyMirror therapy is a type of rehabilitation where visual feedback is employed to induce movement and recovery in an affected limb by asking the patients to observe the reflection of their healthy limb in a mirror, giving the illusion that both limbs are moving normally. | Other | Group 2: Mirror Therapy |
| Designed physical therapy program.The program will start with 10 minutes of poolside exercises including warming up, active range of motion and stretching followed by 20 minutes of aquatic exercise in the pool. The pool session consists of 20 minutes of active range of motion, stretching and strengthening exercises | Other | Group 1: Aquatic Therapy, Group 2: Mirror Therapy, Group 3: Control Group |
Primary outcome
Box and Block Test: It was used to assess gross manual dexterity
Time frame: 3 Months
The Box and Block Test (BBT) is a widely used test to evaluate gross manual dexterity by rehabilitation centers and occupational therapy clinics. The individual has to move as many blocks as possible from one of the compartments of a box to the other in a given time period, usually one minute, using one hand at a time. The BBT is valued for simplicity, ease of use, and strong reliability and validity across the lifespan, and in clinical populations like children, adults, and those with neurological or musculoskeletal disorder
Hand held dynamometer to assess hand grip strength.
Time frame: 3 Months
A popular, trustworthy, and legitimate tool for evaluating hand grip strength-a crucial sign of general muscle function and health-is a hand-held dynamometer.
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 22 Jul 2025.
- Results publication: PubMed 31453460Adar S, Dundar U, Demirdal US, Ulasli AM, Toktas H, Solak O. The effect of aquatic exercise on spasticity, quality of life, and motor function in cerebral palsy. Turk J Phys Med Rehabil. 2017 Aug 14;63(3):239-248. doi: 10.5606/tftrd.2017.280. eCollection 2017 Jun.
- Results publication: PubMed 27967298Roostaei M, Baharlouei H, Azadi H, Fragala-Pinkham MA. Effects of Aquatic Intervention on Gross Motor Skills in Children with Cerebral Palsy: A Systematic Review. Phys Occup Ther Pediatr. 2017 Oct 20;37(5):496-515. doi: 10.1080/01942638.2016.1247938. Epub 2016 Dec 14.
- Results publication: PubMed 28410250El-Shamy SM. Effects of Antigravity Treadmill Training on Gait, Balance, and Fall Risk in Children With Diplegic Cerebral Palsy. Am J Phys Med Rehabil. 2017 Nov;96(11):809-815. doi: 10.1097/PHM.0000000000000752.
- Results publication: PubMed 24907137Lai CJ, Liu WY, Yang TF, Chen CL, Wu CY, Chan RC. Pediatric aquatic therapy on motor function and enjoyment in children diagnosed with cerebral palsy of various motor severities. J Child Neurol. 2015 Feb;30(2):200-8. doi: 10.1177/0883073814535491. Epub 2014 Jun 5.
- Results publication: PubMed 28174435Ryu K, Ali A, Kwon M, Lee C, Kim Y, Lee G, Kim J. Effects of assisted aquatic movement and horseback riding therapies on emotion and brain activation in patients with cerebral palsy. J Phys Ther Sci. 2016 Dec;28(12):3283-3287. doi: 10.1589/jpts.28.3283. Epub 2016 Dec 27.
- Results publication: PubMed 28243583Stavsky M, Mor O, Mastrolia SA, Greenbaum S, Than NG, Erez O. Cerebral Palsy-Trends in Epidemiology and Recent Development in Prenatal Mechanisms of Disease, Treatment, and Prevention. Front Pediatr. 2017 Feb 13;5:21. doi: 10.3389/fped.2017.00021. eCollection 2017.
- Individual participant dataSharing planned: No. It will provided only upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aquatic Exercise, Mirror Therapy and Designed physical therapy program. in people with Cerebral Palsy (CP) and Hemiplegia and Hemiparesis, run by Alaa Noureldeen Kora at 1 site in Egypt.
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 9 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: under way, not looking for participants, as of the sponsor's last update on 22 Jul 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 Egypt. 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?
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?
Box and Block Test: It was used to assess gross manual dexterity (time frame: 3 Months). The study lists 2 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 NCT07072416, which also lists 6 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 22 Jul 2025; AzTrials last refreshed its copy on 1 Nov 2026.