Spastic Diplegia Cerebral PalsyNCT06686719
Post Facilitation Stretch, Post Isometric Relaxation and Myofascial Release in Spastic Cerebral Palsy.
A study testing Post Facilitation, Post Isometric Relaxation and Myofascial Release in people with Spastic Diplegia Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
The purpose of the study is to compare the effect of Post Facilitation Stretch, Post Isometric Relaxation and Myofascial Release on Lower Limb Spasticity in Spastic Cerebral Palsy. A randomized control trial was conducted at PAF School for PSN NUR KHAN Rawalpindi. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Spastic Diplegia Cerebral Palsy
- What is being tested?
- Post Facilitation, Post Isometric Relaxation and Myofascial Release
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 3 May 2024to 13 Dec 2024
- 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Spasticity score of less than 3 on MAS
- Known cases of Spastic diplegic cerebral palsy.
- Children who follow commands.
Who cannot join
- Epilepsy history
- hip or spinal deformities
- Severe contractures, joint dislocations
- Discrepancy in leg length
- Recent orthopedic surgery
- Children with cognitive impairment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
PAF School For PSN NUR KHAN
Rawalpindi
Muhammad Arslan Malik, MS*, +923335757407, arslan967m@gmail.com
About this study
Official title: Comparison of Post Facilitation Stretch, Post Isometric Relaxation and Myofascial Release on Lower Limb Spasticity in Spastic Cerebral Palsy.
The purpose of the study is to compare the effect of Post Facilitation Stretch, Post Isometric Relaxation and Myofascial Release on Lower Limb Spasticity in Spastic Cerebral Palsy. A randomized control trial was conducted at PAF School for PSN NUR KHAN Rawalpindi. The sample size was 30 calculated through G-Power tool. The participants were divided into three interventional groups each having 10 participants. The study duration was six months. Sampling technique applied was Convenient sampling for recruitment and group randomization using lottery method. Only 8 to 18 years Spastic Dipelgic CP children with Modified Asworth Scale having score 1, 1+ and 2 were included in the study. Tools used in this study are Goniometer, Modified Ashworth Scale, Active knee extension test, Weight bearing lunge test. Data was collected before and immediately after the application of interventions. Data analyzed through SPSS version 26.
Read the detailed description
Cerebral palsy (CP) is a disorder affecting movement, resulting from permanent damage to posture and motor development during fetal or infant brain development, caused by non-progressive disturbances. CP affecting about 1 in 500 children with an estimated prevalence of 17 million people worldwide. In CP, spasticity is often regarded to be the most common motor impairment. Spastic cerebral palsy stands out as the predominant subtype, constituting 77% of all cases, with bilateral spastic cerebral palsy dominating the spastic group (70%). Spasticity is only one of several components of the upper motor neuron (UMN) syndrome. Spasticity is a form of hypertonia due to hyperexcitable tonic stretch reflexes. Adult CP reported that 77% of CP children were having problems with spasticity. Hypertonicity resulting in abnormal movement patterns in both gross motor function and manual abilities in the children with CP.
Traditionally the treatment of tightness in children with spasticity has consisted primarily of techniques which involve static stretching, strengthening of the antagonistic muscles, use of orthosis and postural education etc. Some authorities also recommend Myofascial release to cause elongation of the spastic muscle with a component of tightness. Myofascial therapy can be defined as "the facilitation of mechanical, neural and psycho physiological adaptive potential as interfaced by the myofascial system". Akta Bhalara et al (2014) concluded in a study that myofascial release is effective in reducing spasticity in children suffering from spastic diplegic cerebral palsy. A study conducted in 2018 proved that myofascial release is effective in reducing spasticity of hamstring muscle and improves range of motion in spastic diplegic cerebral palsy. Ujwal Bhattacharya et al (2017) in a study concluded that MFR and passive stretching is effective in reducing spasticity and improving range of motion in spastic diplegic Cerebral Palsy.
Fred Mitchell first described MET in 1948 as a type of osteopathic manipulative diagnosis and treatment, primarily utilized to address somatic dysfunction, particularly issues such as reduced range of motion, muscular hypertonicity, and pain. MET involves the use of two physiological phenomena: Post Isometric Relaxation and Reciprocal Inhibition. Post Isometric Relaxation is a technique that was later developed by Karel Lewitt . Post Isometric Relaxation (PIR) is the effect of the decrease in muscle tone in a single or group of muscles, after a brief period of submaximal isometric contraction of the same muscle.
Preeti Gazbare et al ( 2018) conducted a Comparative Study On The Effect of Myofascial Release Over Post Isometric Relaxation On Calf Muscle Tone in Spastic Diplegic Cerebral Palsy and concluded that both MFR and PIR are equally effected in reducing calf muscle tone in spastic Cerebral Palsy. PIR improves better flexibility and decrease tightness of hamstring muscle as compared to static stretching. MET improves the independent mobility of stroke patients with hemiplegia enhances balance and stability. Janstephan T (2015) conducted a study to evaluate the effectiveness of neurodevelopment therapy with post isometric relaxation for lower extremity to improve functional ability in children with spastic diplegic cerebral palsy. The result suggested that neurodevelopmental therapy along with muscle energy technique improved the functional ability in children with spastic diplegic cerebral palsy.
Post Facilitation Stretch (PFS) is a technique developed by Janda.This technique is more aggressive than PIR but is also based on the concept of autogenic inhibition. Post facilitation stretching is a MET technique which uses postisometric relaxation. The term refers to the effect of the subsequent relaxation experienced by a muscle after an isometric contraction has been performed. The effect of a sustained contraction on the Golgi tendon organs seems pivotal, since their response to such a contraction seems to be set the tendon and the muscle to a new length by inhibiting it. A study concluded that Post Facilitation Stretching is effective in increasing Flexibility of tight hamstring muscles. A study concluded that post facilitation stretch is effective in reducing pain and improving muscle length. A study in published in 2024 compared the effect of the muscle energy technique (MET) and stretching technique on ankle dorsiflexion passive range of motion, balance, and gait ability of stroke patients with limited ankle dorsiflexion. And concluded that MET and Stretching both are effective in improving range of motion , balance and gait ability of stroke patients with limited ankle dorsiflexion.
The rationale for this study is that Post-facilitation stretch relaxation (PFSR) is proposed as an effective intervention for reducing lower limb spasticity in spastic cerebral palsy. By combining passive stretching with relaxation techniques post- facilitation, PFSR aims to decrease muscle tone and improve range of motion. This approach is individualized, often integrated with other therapies, and emphasizes patient education for long term management.
- Conditions
- Spastic Diplegia Cerebral Palsy
- Being tested
- Post Facilitation, Post Isometric Relaxation, Myofascial Release
- Keywords
- Spastic Cerebral Palsy, Myofascial, Spasticity
- Medical subject headings
- Cerebral palsy, spastic, diplegic, Cerebral Palsy, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post FacilitationOther
For hamstring muscle, the patient positioned in supine with hip and knee flexed to mid- range. For calf muscle, the patient positioned in supine with straight leg. Now therapist ask the subjects to isometrically contract the hamstring and calf using 30 % of the strength for 15 seconds by attempting to push the leg back toward the therapist and relax. The therapist then passively stretched the muscle until a mild stretch sensation was reported. The stretch was held for another 10 seconds. This sequence will repeat 5 times on each subject in the group.
Stretching of the hip flexors, adductors and plantar flexors. Functional training includes bridging, kneeling and sit to stand.
Post Isometric RelaxationOther
For hamstring muscle, the patient positioned in supine with hip and knee flexed. For calf muscle, the patient positioned in supine with straight leg. Now therapist ask the subjects to isometrically contract the hamstring and calf using 25 % of the strength for 7-10 seconds by attempting to push the leg back toward the therapist and relax.After relaxation, the therapist further extends the knee for 3 to 5 seconds.. This sequence will repeat 5 times on each subject in the group.
Stretching of the hip flexors, adductors and plantar flexors. Functional training includes bridging, kneeling and sit to stand.
Myofascial ReleaseOther
MFR for Hamstring muscle will be given with patient in prone position with 120 second hold. For giving the MFR, the thumb of the therapist will be allowed to sink in to the central portion of the hamstring. It will held for 120 seconds to allow the tissue to soften and then myofascial structures will spread in a lateral direction until feeling of first fascial barrier. MFR will be performed for 15 mins.
Stretching of the hip adductors, hip flexors and plantar flexors. Functional training includes kneeling, bridging and sit to stand.
| Study group | Role | What they receive |
|---|---|---|
| Post Facilitation group | Experimental | subjects are asked to isometrically contract the hamstring and calf using 30 % of the strength for 15 seconds by attempting to push the leg back toward the therapist and relax. The therapist then passively stretched the muscle until a mild stretch sensation was reported. The stretch was held for another 10 seconds. This sequence will repeat 5 times on each subject in the group.
Stretching of the hip flexors, adductors and plantarflexor muscles. Functional training includes bridging, kneeling, sit to stand Receives: Other: Post Facilitation |
| Post Isometric Relaxation | Active comparator | Subjects are asked to isometrically contract the hamstring and calf using 25 % of the strength for 7-10 seconds by attempting to push the leg back toward the therapist and relax. After relaxation, the therapist further extends the knee for 3 to 5 seconds. This sequence will repeat 5 times on each subject in the group.
Stretching of the hip flexors, adductors and plantarflexor muscles. Functional training includes bridging, kneeling, sit to stand. Receives: Other: Post Isometric Relaxation |
| Myofascial Release | Active comparator | MFR for Hamstring muscle will be given with patient in prone position with 120 second hold. For giving the MFR, the thumb of the therapist will be allowed to sink in to the central portion of the hamstring. It will held for 120 seconds to allow the tissue to soften and then myofascial structures will spread in a lateral direction until feeling of first fascial barrier. MFR will be performed for 15 mins. Receives: Other: Myofascial Release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Ashworth Scale
Changes from the baseline spasticity measured with help of modified ashworth scale
Measured: Four Weeks
Range of motion
Changes from baseline range of motion of hip, knee and ankle will be measured with help of goniometer.
Measured: Four Weeks
Secondary outcomes (2)
Active Knee Extension Test
Changes from the baseline hamstring tightness will be measured with active knee extension test
Measured: Four Weeks
Weight Bearing Lunge Test
Changes from the baseline calf tightness will be measured with weight bearing lunge test
Measured: Four Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start3 May 2024
- Primary completion3 Dec 2024 (estimated)
- Study completion13 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spastic Diplegia 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ammanullah Nazir, PHD*, Principal investigator, Riphah International University Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06686719
- Sponsor's protocol ID
- Riphah/RCRAHS/REC/MS-PT/01942
- Status last verified
- Nov 2024
- First submitted
- 12 Nov 2024
- Last updated
- 13 Nov 2024
- 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 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Post Facilitation Stretch, Post Isometric Relaxation and Myofascial Release on Lower Limb Spasticity in Spastic Cerebral Palsy.
- ClinicalTrials.gov ID
- NCT06686719
- Acronym / sponsor ID
- Riphah/RCRAHS/REC/MS-PT/01942
- Conditions
- Spastic Diplegia Cerebral Palsy
- Keywords
- Spastic Cerebral Palsy, Myofascial, Spasticity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 3 May 2024 (actual)
- Primary completion
- 3 Dec 2024 (estimated)
- Study completion
- 13 Dec 2024 (estimated)
- First posted
- 13 Nov 2024 (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 purpose of the study is to compare the effect of Post Facilitation Stretch, Post Isometric Relaxation and Myofascial Release on Lower Limb Spasticity in Spastic Cerebral Palsy. A randomized control trial was conducted at PAF School for PSN NUR KHAN Rawalpindi. The sample size was 30 calculated through G-Power tool. The participants were divided into three interventional groups each having 10 participants. The study duration was six months. Sampling technique applied was Convenient sampling for recruitment and group randomization using lottery method. Only 8 to 18 years Spastic Dipelgic CP children with Modified Asworth Scale having score 1, 1+ and 2 were included in the study. Tools used in this study are Goniometer, Modified Ashworth Scale, Active knee extension test, Weight bearing lunge test. Data was collected before and immediately after the application of interventions. Data analyzed through SPSS version 26.
Detailed description
Cerebral palsy (CP) is a disorder affecting movement, resulting from permanent damage to posture and motor development during fetal or infant brain development, caused by non-progressive disturbances. CP affecting about 1 in 500 children with an estimated prevalence of 17 million people worldwide. In CP, spasticity is often regarded to be the most common motor impairment. Spastic cerebral palsy stands out as the predominant subtype, constituting 77% of all cases, with bilateral spastic cerebral palsy dominating the spastic group (70%). Spasticity is only one of several components of the upper motor neuron (UMN) syndrome. Spasticity is a form of hypertonia due to hyperexcitable tonic stretch reflexes. Adult CP reported that 77% of CP children were having problems with spasticity. Hypertonicity resulting in abnormal movement patterns in both gross motor function and manual abilities in the children with CP.
Traditionally the treatment of tightness in children with spasticity has consisted primarily of techniques which involve static stretching, strengthening of the antagonistic muscles, use of orthosis and postural education etc. Some authorities also recommend Myofascial release to cause elongation of the spastic muscle with a component of tightness. Myofascial therapy can be defined as "the facilitation of mechanical, neural and psycho physiological adaptive potential as interfaced by the myofascial system". Akta Bhalara et al (2014) concluded in a study that myofascial release is effective in reducing spasticity in children suffering from spastic diplegic cerebral palsy. A study conducted in 2018 proved that myofascial release is effective in reducing spasticity of hamstring muscle and improves range of motion in spastic diplegic cerebral palsy. Ujwal Bhattacharya et al (2017) in a study concluded that MFR and passive stretching is effective in reducing spasticity and improving range of motion in spastic diplegic Cerebral Palsy.
Fred Mitchell first described MET in 1948 as a type of osteopathic manipulative diagnosis and treatment, primarily utilized to address somatic dysfunction, particularly issues such as reduced range of motion, muscular hypertonicity, and pain. MET involves the use of two physiological phenomena: Post Isometric Relaxation and Reciprocal Inhibition. Post Isometric Relaxation is a technique that was later developed by Karel Lewitt . Post Isometric Relaxation (PIR) is the effect of the decrease in muscle tone in a single or group of muscles, after a brief period of submaximal isometric contraction of the same muscle.
Preeti Gazbare et al ( 2018) conducted a Comparative Study On The Effect of Myofascial Release Over Post Isometric Relaxation On Calf Muscle Tone in Spastic Diplegic Cerebral Palsy and concluded that both MFR and PIR are equally effected in reducing calf muscle tone in spastic Cerebral Palsy. PIR improves better flexibility and decrease tightness of hamstring muscle as compared to static stretching. MET improves the independent mobility of stroke patients with hemiplegia enhances balance and stability. Janstephan T (2015) conducted a study to evaluate the effectiveness of neurodevelopment therapy with post isometric relaxation for lower extremity to improve functional ability in children with spastic diplegic cerebral palsy. The result suggested that neurodevelopmental therapy along with muscle energy technique improved the functional ability in children with spastic diplegic cerebral palsy.
Post Facilitation Stretch (PFS) is a technique developed by Janda.This technique is more aggressive than PIR but is also based on the concept of autogenic inhibition. Post facilitation stretching is a MET technique which uses postisometric relaxation. The term refers to the effect of the subsequent relaxation experienced by a muscle after an isometric contraction has been performed. The effect of a sustained contraction on the Golgi tendon organs seems pivotal, since their response to such a contraction seems to be set the tendon and the muscle to a new length by inhibiting it. A study concluded that Post Facilitation Stretching is effective in increasing Flexibility of tight hamstring muscles. A study concluded that post facilitation stretch is effective in reducing pain and improving muscle length. A study in published in 2024 compared the effect of the muscle energy technique (MET) and stretching technique on ankle dorsiflexion passive range of motion, balance, and gait ability of stroke patients with limited ankle dorsiflexion. And concluded that MET and Stretching both are effective in improving range of motion , balance and gait ability of stroke patients with limited ankle dorsiflexion.
The rationale for this study is that Post-facilitation stretch relaxation (PFSR) is proposed as an effective intervention for reducing lower limb spasticity in spastic cerebral palsy. By combining passive stretching with relaxation techniques post- facilitation, PFSR aims to decrease muscle tone and improve range of motion. This approach is individualized, often integrated with other therapies, and emphasizes patient education for long term management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Post Facilitation group | Experimental | Other: Post Facilitationsubjects are asked to isometrically contract the hamstring and calf using 30 % of the strength for 15 seconds by attempting to push the leg back toward the therapist and relax. The therapist then passively stretched the muscle until a mild stretch sensation was reported. The stretch was held for another 10 seconds. This sequence will repeat 5 times on each subject in the group. Stretching of the hip flexors, adductors and plantarflexor muscles. Functional training includes bridging, kneeling, sit to stand |
| Post Isometric Relaxation | Active comparator | Other: Post Isometric RelaxationSubjects are asked to isometrically contract the hamstring and calf using 25 % of the strength for 7-10 seconds by attempting to push the leg back toward the therapist and relax. After relaxation, the therapist further extends the knee for 3 to 5 seconds. This sequence will repeat 5 times on each subject in the group. Stretching of the hip flexors, adductors and plantarflexor muscles. Functional training includes bridging, kneeling, sit to stand. |
| Myofascial Release | Active comparator | Other: Myofascial ReleaseMFR for Hamstring muscle will be given with patient in prone position with 120 second hold. For giving the MFR, the thumb of the therapist will be allowed to sink in to the central portion of the hamstring. It will held for 120 seconds to allow the tissue to soften and then myofascial structures will spread in a lateral direction until feeling of first fascial barrier. MFR will be performed for 15 mins. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Spasticity score of less than 3 on MAS
- Known cases of Spastic diplegic cerebral palsy.
- Children who follow commands.
Key exclusion criteria (6 listed)
- Epilepsy history
- hip or spinal deformities
- Severe contractures, joint dislocations
- Discrepancy in leg length
- Recent orthopedic surgery
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 |
|---|---|---|
| Post FacilitationFor hamstring muscle, the patient positioned in supine with hip and knee flexed to mid- range. For calf muscle, the patient positioned in supine with straight leg. Now therapist ask the subjects to isometrically contract the hamstring and calf using 30 % of the strength for 15 seconds by attempting to push the leg back toward the therapist and relax. The therapist then passively stretched the muscle until a mild stretch sensation was reported. The stretch was held for another 10 seconds. This sequence will repeat 5 times on each subject in the group. Stretching of the hip flexors, adductors and plantar flexors. Functional training includes bridging, kneeling and sit to stand. | Other | Post Facilitation group |
| Post Isometric RelaxationFor hamstring muscle, the patient positioned in supine with hip and knee flexed. For calf muscle, the patient positioned in supine with straight leg. Now therapist ask the subjects to isometrically contract the hamstring and calf using 25 % of the strength for 7-10 seconds by attempting to push the leg back toward the therapist and relax.After relaxation, the therapist further extends the knee for 3 to 5 seconds.. This sequence will repeat 5 times on each subject in the group. Stretching of the hip flexors, adductors and plantar flexors. Functional training includes bridging, kneeling and sit to stand. | Other | Post Isometric Relaxation |
| Myofascial ReleaseMFR for Hamstring muscle will be given with patient in prone position with 120 second hold. For giving the MFR, the thumb of the therapist will be allowed to sink in to the central portion of the hamstring. It will held for 120 seconds to allow the tissue to soften and then myofascial structures will spread in a lateral direction until feeling of first fascial barrier. MFR will be performed for 15 mins. Stretching of the hip adductors, hip flexors and plantar flexors. Functional training includes kneeling, bridging and sit to stand. | Other | Myofascial Release |
Primary outcome
Modified Ashworth Scale
Time frame: Four Weeks
Changes from the baseline spasticity measured with help of modified ashworth scale
Range of motion
Time frame: Four Weeks
Changes from baseline range of motion of hip, knee and ankle will be measured with help of goniometer.
2 secondary outcomes
Active Knee Extension Test
Time frame: Four Weeks
Weight Bearing Lunge Test
Time frame: Four Weeks
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 13 Nov 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.
Ammanullah Nazir, PHD* principal investigator
Riphah International University Islamabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Post Facilitation, Post Isometric Relaxation and Myofascial Release in people with Spastic Diplegia Cerebral Palsy, run by Riphah International University 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 3 inclusion and 6 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 13 Nov 2024. 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 Imran Amjad, PHD (+923324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Ashworth Scale (time frame: Four Weeks). 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?
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 13 Nov 2024; AzTrials last refreshed its copy on 26 Oct 2026.