Healthy ChildrenCS-CHILDRENNCT05002504
Craniosacral Therapy Children's, Balance-Coordination
A study testing A series of questions were asked to the children's parents in a virtual questionnaire, neurobehavioral aspects of the students using the "Battelle Developmental Inventory" (BDI) and Therapy sessions in people with Healthy Children, run by Clinica Gema Leon at 1 site in Spain.
Trial summary
Coordination and balance are manifested as motor skills or abilities that are acquired as the Central Nervous System develops. In the infant stage, these qualities help guide specialists to recognize possible abnormalities that at first glance seem banal, but that, as time goes by, acquire greater difficulty, causing… Read more about this study
- Who is it for?
- Ages 6 to 8 years
- Conditions the study is for
- Healthy Children
- What is being tested?
- A series of questions were asked to the children's parents in a virtual questionnaire, neurobehavioral aspects of the students using the "Battelle Developmental Inventory" (BDI) and Therapy sessions
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteSpain
- Study dates
- 1 Aug 2021to 28 Dec 2021
- 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 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- healthy children
- aged 6 to 8 years old
- school group
Who cannot join
- unhealthy children
- ages outside the 6-8 age range
Trial locations and contacts
1 site in 1 country.
Spain1 site
Gema León Physiotherapy and Rehabilitation Clinic
Córdoba, Andalusia, 14011
About this study
Official title: Craniosacral Therapy as a Neurodevelopmental Correction for the Improvement of Children's Balance and Coordination.
Coordination and balance are manifested as motor skills or abilities that are acquired as the Central Nervous System develops. In the infant stage, these qualities help guide specialists to recognize possible abnormalities that at first glance seem banal, but that, as time goes by, acquire greater difficulty, causing even more complex problems in the long term. Craniosacral therapy could help these skills to be correctly established during growth, correcting such impairment in time during neurodevelopment. Objective: To correct possible alterations that occur during infant growth related to balance and coordination in neurodevelopment, by means of craniosacral therapy compared with the specific therapy of balance and coordination usually used in pathologies diagnosed of this caliber. Design: Longitudinal-experimental study with a population of 86 apparently healthy children. Setting/Participants: 86 children were treated without excluding sex and divided into three groups: placebo group (n=25), craniosacral therapy group (n=30) and balance and coordination therapy group (n=31). Interventions: group 1 (placebo), group 2 (craniosacral therapy) group 3 (balance and coordination therapy). Results: The Battelle scale prior to the therapies developed in the study showed balance and coordination imbalances in the participants of the three groups, with lower percentages in the placebo treatment. Sessions from the 2nd to the 7th of treatment show increasing percentages and fluctuating for craniosacral therapy between 51% to 56% and 100% satisfaction, significantly valued. As for balance and coordination therapy, satisfaction percentages are evident only in the 6th and 7th sessions, with statistically significant values. Finally, the Battelle post-therapy assessment scale shows a higher number of participants in the percentages classified as normal (50-80%) in the craniosacral therapy group, improving the evaluated parameters with statistically significant values. Conclusion: The study shows that craniosacral therapy can not only act as a treatment for the improvement of children's balance and coordination, but also helps small corrections during children's neurodevelopment, avoiding the evolution of pathologies in the long term. It is therefore necessary for a more prompt, total and lasting correction of these skills in the infant.
Read the detailed description
Design:
A longitudinal-experimental study was carried out with a child population of 86 children aged 6 to 8 years old without excluding sex in a school group in Cordoba (Spain).
Participants:
Eighty-six apparently healthy children between 6 and 8 years of age were treated as prevention in balance and coordination motor skills at the Gema León physiotherapy clinic in Córdoba (Spain). The children were divided into three groups: 25 patients in the placebo group (group 1), 30 patients in the craniosacral therapy group (group 2) and 31 patients in the balance and coordination therapy group (group 3).
Primary outcome: A series of questions were asked to the children's parents in a virtual questionnaire on physical characteristics, previous health assessments and observations of their balance and coordination in front of their children. On the other hand, the school teachers examined neurobehavioral aspects of the students using the "Battelle Developmental Inventory" (BDI), which evaluates five areas of development (personal/social, adaptive, motor, communicative and cognitive) between 2 and 8 years of age. The results are assigned in age-adjusted percentages, classified as: low (0-49%), normal (50-79%) and high (80-100%). Low and high values are considered impairments in one or more of the areas evaluated.
Secondary outcome: Seven treatment sessions were carried out with the balance and coordination therapeutic exercise techniques (group 3) most frequently used for the treatment of these pathologies; seven sessions of craniosacral therapy (group 2) as corrective and preventive in possible alterations during infant neurodevelopment and finally seven sessions simulating craniosacral therapy on a placebo group (group 1) as a control of the treatments used.
The effectiveness values of the therapies were expressed as percentages of satisfaction with the classifications of 25 to 28% (apparent changes < to half of the sample in each therapy group), 51 to 56% (apparent changes in half of the sample in each therapy group) and 100% (apparent changes > to half of the sample in each therapy group). From the above, the absolute values of the sample in each therapy group are set as follows.
Data analysis:
The variables were expressed as mean, absolute and relative frequency. The chi-square test was used to analyze the differences between age ranges, balance and coordination problems versus physical therapy sessions performed, as well as the association between values of the Battelle scale of child neurodevelopment before and after the treatments. A confidence level of 95% was established, considering as statistically significant a value of p a value of p<0.05 was considered statistically significant.
- Conditions
- Healthy Children
- Being tested
- A series of questions were asked to the children's parents in a virtual questionnaire, neurobehavioral aspects of the students using the "Battelle Developmental Inventory" (BDI), Therapy sessions
- Keywords
- Balance, Coordination, Craniosacral therapy, infants, physiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A series of questions were asked to the children's parents in a virtual questionnaireDiagnostic test
Also called questions were asked to the children's parents
A series of questions were asked to the children's parents in a virtual questionnaire on physical characteristics, previous health assessments and observations of their balance and coordination in front of their children
neurobehavioral aspects of the students using the "Battelle Developmental Inventory" (BDI)Diagnostic test
Also called "Battelle Developmental Inventory" (BDI)
the school teachers examined neurobehavioral aspects of the students using the "Battelle Developmental Inventory" (BDI), which evaluates five areas of development (personal/social, adaptive, motor, communicative and cognitive) between 2 and 8 years of age. The results are assigned in age-adjusted percentages, classified as: low (0-49%), normal (50-79%) and high (80-100%). Low and high values are considered impairments in one or more of the areas evaluated. Evaluation of the Battelle scale was carried out before and after the therapy sessions.
Therapy sessionsProcedure or surgery
Seven treatment sessions were carried out with the balance and coordination therapeutic exercise techniques (group 3) most frequently used for the treatment of these pathologies; seven sessions of craniosacral therapy (group 2) as corrective and preventive in possible alterations during infant neurodevelopment and finally seven sessions simulating craniosacral therapy on a placebo group (group 1) as a control of the treatments used.
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving craniosacral therapy | Experimental | 30 children without previous pathology receiving craniosacral therapy Receives: Diagnostic Test: A series of questions were asked to the children's parents in a virtual questionnaire; Diagnostic Test: neurobehavioral aspects of the students using the "Battelle Developmental Inventory" (BDI); Procedure: Therapy sessions |
| Patients receiving balance and coordination therapy | Active comparator | 31 patients without previous pathology receiving balance and coordination therapy Receives: Diagnostic Test: A series of questions were asked to the children's parents in a virtual questionnaire; Diagnostic Test: neurobehavioral aspects of the students using the "Battelle Developmental Inventory" (BDI); Procedure: Therapy sessions |
| Patients receiving placebo | Placebo comparator | 25 patients without previous pathology receiving placebo Receives: Diagnostic Test: A series of questions were asked to the children's parents in a virtual questionnaire; Diagnostic Test: neurobehavioral aspects of the students using the "Battelle Developmental Inventory" (BDI); Procedure: Therapy sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
"Series of questions to the children's parents"
A series of questions were asked to the children's parents in a virtual questionnaire on physical characteristics, previous health assessments and observations of their balance and coordination in front of their children
Measured: two weeks
"Battelle Developmental Inventory" (BDI)
On the other hand, the school teachers examined neurobehavioral aspects of the students using the "Battelle Developmental Inventory" (BDI), which evaluates five areas of development (personal/social, adaptive, motor, communicative and cognitive) between 2 and 8 years of age. The results are assigned in age-adjusted percentages, classified as: low (0-49%), normal (50-79%) and high (80-100%). Low and high values are considered impairments in one or more of the areas evaluated
Measured: two weeks
Secondary outcomes (5)
"Number of participants in each therapy group"
86 children were treated under stipulated physiotherapy techniques without excluding sex or age and divided into three groups: placebo group (n = 25), craniosacral therapy group (n = 30) and balance and coordination therapy group (n = 31). Each of the groups received the same number of therapeutic sessions (n = 7) spread over an equal period of time (one weekly session).
Measured: Seven weeks
"The effectiveness values of the therapies for each group"
The effectiveness values of the therapies were expressed as percentages of satisfaction with the classifications of 25 to 28% (apparent changes < to half of the sample in each therapy group), 51 to 56% (apparent changes in half of the sample in each therapy group) and 100% (apparent changes > to half of the sample in each therapy group).
Measured: seven weeks
"Pre-treatment Battelle Scale"
The pre-treatment assessments with the Battelle scale performed by the teachers evidenced the value of participants in all percentage ranges (low, normal and high), showing unevenness or alterations in primary explorations or assessments such as balance on two feet with eyes open and closed, on one foot with eyes open and closed (in neutral pelvis position), assessment of coordination in fast and slow movements and assessment of the coordination of the weaker side within their motor skills
Measured: two weeks
"Post-treatment Battelle Scale"
The evaluation by the teachers with the Battelle scale after the treatment shows statistically significant values in the participants of the craniosacral therapy group (n=30), improving the parameters that they evaluate with respect to neurodevelopment, with 0% being in the low values (0-50) and 93% in normal values (50-80), rectifying the possible corrections made by means of this therapy
Measured: two weeks
"percentages of satisfaction from 1st to the 7th therapy sessions"
Significance values are observed for craniosacral therapy participants (n=30) showing apparent changes in gradual increases in the categories of 25-28% satisfaction from the 2nd session (n=20), moving to 51-56% satisfaction in the 3rd session (n=18) and swinging in gradual increases towards 100% satisfaction by the 5th session (n=15), showing that craniosacral therapy regulates small weaknesses or alterations previously observed during the balance and coordination exploration.
During the sixth treatment session, craniosacral therapy shows higher percentages of apparent changes that position it with better satisfaction compared to balance and coordination therapy.
The last treatment session presented a greater percentage advantage in the craniosacral therapy in relation to the balance and coordination therapy, ratifying the values previously exposed.
Measured: seven weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start1 Aug 2021
- Primary completion17 Oct 2021
- Study completion28 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ChildrenStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 25 patients in the placebo group (group 1), 30 patients in the craniosacral therapy group (group 2) and 31 patients in the balance and coordination therapy group (group 3)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Gema Leon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GEMA LEÓN BRAVO, Clinica Gema Leon
- Investigators
- Irene Cantarero Carmona, Study chair, Universidad de Córdoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05002504
- Sponsor's protocol ID
- ART-GLB-CS-EQUILIB-COORD
- Acronym
- CS-CHILDREN
- Status last verified
- Dec 2021
- First submitted
- 7 Aug 2021
- Last updated
- 29 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The request for the data will be studied and considered upon prior and justified request.
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Craniosacral Therapy as a Neurodevelopmental Correction for the Improvement of Children's Balance and Coordination.
- ClinicalTrials.gov ID
- NCT05002504
- Acronym / sponsor ID
- CS-CHILDREN / ART-GLB-CS-EQUILIB-COORD
- Conditions
- Healthy Children
- Keywords
- Balance, Coordination, Craniosacral therapy, infants, physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Clinica Gema LeonUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 17 Oct 2021 (actual)
- Study completion
- 28 Dec 2021 (actual)
- First posted
- 12 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Coordination and balance are manifested as motor skills or abilities that are acquired as the Central Nervous System develops. In the infant stage, these qualities help guide specialists to recognize possible abnormalities that at first glance seem banal, but that, as time goes by, acquire greater difficulty, causing even more complex problems in the long term. Craniosacral therapy could help these skills to be correctly established during growth, correcting such impairment in time during neurodevelopment. Objective: To correct possible alterations that occur during infant growth related to balance and coordination in neurodevelopment, by means of craniosacral therapy compared with the specific therapy of balance and coordination usually used in pathologies diagnosed of this caliber. Design: Longitudinal-experimental study with a population of 86 apparently healthy children. Setting/Participants: 86 children were treated without excluding sex and divided into three groups: placebo group (n=25), craniosacral therapy group (n=30) and balance and coordination therapy group (n=31). Interventions: group 1 (placebo), group 2 (craniosacral therapy) group 3 (balance and coordination therapy). Results: The Battelle scale prior to the therapies developed in the study showed balance and coordination imbalances in the participants of the three groups, with lower percentages in the placebo treatment. Sessions from the 2nd to the 7th of treatment show increasing percentages and fluctuating for craniosacral therapy between 51% to 56% and 100% satisfaction, significantly valued. As for balance and coordination therapy, satisfaction percentages are evident only in the 6th and 7th sessions, with statistically significant values. Finally, the Battelle post-therapy assessment scale shows a higher number of participants in the percentages classified as normal (50-80%) in the craniosacral therapy group, improving the evaluated parameters with statistically significant values. Conclusion: The study shows that craniosacral therapy can not only act as a treatment for the improvement of children's balance and coordination, but also helps small corrections during children's neurodevelopment, avoiding the evolution of pathologies in the long term. It is therefore necessary for a more prompt, total and lasting correction of these skills in the infant.
Detailed description
Design:
A longitudinal-experimental study was carried out with a child population of 86 children aged 6 to 8 years old without excluding sex in a school group in Cordoba (Spain).
Participants:
Eighty-six apparently healthy children between 6 and 8 years of age were treated as prevention in balance and coordination motor skills at the Gema León physiotherapy clinic in Córdoba (Spain). The children were divided into three groups: 25 patients in the placebo group (group 1), 30 patients in the craniosacral therapy group (group 2) and 31 patients in the balance and coordination therapy group (group 3).
Primary outcome: A series of questions were asked to the children's parents in a virtual questionnaire on physical characteristics, previous health assessments and observations of their balance and coordination in front of their children. On the other hand, the school teachers examined neurobehavioral aspects of the students using the "Battelle Developmental Inventory" (BDI), which evaluates five areas of development (personal/social, adaptive, motor, communicative and cognitive) between 2 and 8 years of age. The results are assigned in age-adjusted percentages, classified as: low (0-49%), normal (50-79%) and high (80-100%). Low and high values are considered impairments in one or more of the areas evaluated.
Secondary outcome: Seven treatment sessions were carried out with the balance and coordination therapeutic exercise techniques (group 3) most frequently used for the treatment of these pathologies; seven sessions of craniosacral therapy (group 2) as corrective and preventive in possible alterations during infant neurodevelopment and finally seven sessions simulating craniosacral therapy on a placebo group (group 1) as a control of the treatments used.
The effectiveness values of the therapies were expressed as percentages of satisfaction with the classifications of 25 to 28% (apparent changes < to half of the sample in each therapy group), 51 to 56% (apparent changes in half of the sample in each therapy group) and 100% (apparent changes > to half of the sample in each therapy group). From the above, the absolute values of the sample in each therapy group are set as follows.
Data analysis:
The variables were expressed as mean, absolute and relative frequency. The chi-square test was used to analyze the differences between age ranges, balance and coordination problems versus physical therapy sessions performed, as well as the association between values of the Battelle scale of child neurodevelopment before and after the treatments. A confidence level of 95% was established, considering as statistically significant a value of p a value of p<0.05 was considered statistically significant.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 25 patients in the placebo group (group 1), 30 patients in the craniosacral therapy group (group 2) and 31 patients in the balance and coordination therapy group (group 3)
| Arm | Type | Receives |
|---|---|---|
| Patients receiving craniosacral therapy | Experimental | Diagnostic Test: A series of questions were asked to the children's parents in a virtual questionnaire, Diagnostic Test: neurobehavioral aspects of the students using the "Battelle Developmental Inventory" (BDI), Procedure: Therapy sessions30 children without previous pathology receiving craniosacral therapy |
| Patients receiving balance and coordination therapy | Active comparator | Diagnostic Test: A series of questions were asked to the children's parents in a virtual questionnaire, Diagnostic Test: neurobehavioral aspects of the students using the "Battelle Developmental Inventory" (BDI), Procedure: Therapy sessions31 patients without previous pathology receiving balance and coordination therapy |
| Patients receiving placebo | Placebo comparator | Diagnostic Test: A series of questions were asked to the children's parents in a virtual questionnaire, Diagnostic Test: neurobehavioral aspects of the students using the "Battelle Developmental Inventory" (BDI), Procedure: Therapy sessions25 patients without previous pathology receiving placebo |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- healthy children
- aged 6 to 8 years old
- school group
Key exclusion criteria (2 listed)
- unhealthy children
- ages outside the 6-8 age range
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 |
|---|---|---|
| A series of questions were asked to the children's parents in a virtual questionnaireAlso: questions were asked to the children's parentsA series of questions were asked to the children's parents in a virtual questionnaire on physical characteristics, previous health assessments and observations of their balance and coordination in front of their children | Diagnostic test | Patients receiving balance and coordination therapy, Patients receiving craniosacral therapy, Patients receiving placebo |
| neurobehavioral aspects of the students using the "Battelle Developmental Inventory" (BDI)Also: "Battelle Developmental Inventory" (BDI)the school teachers examined neurobehavioral aspects of the students using the "Battelle Developmental Inventory" (BDI), which evaluates five areas of development (personal/social, adaptive, motor, communicative and cognitive) between 2 and 8 years of age. The results are assigned in age-adjusted percentages, classified as: low (0-49%), normal (50-79%) and high (80-100%). Low and high values are considered impairments in one or more of the areas evaluated. Evaluation of the Battelle scale was carried out before and after the therapy sessions. | Diagnostic test | Patients receiving balance and coordination therapy, Patients receiving craniosacral therapy, Patients receiving placebo |
| Therapy sessionsSeven treatment sessions were carried out with the balance and coordination therapeutic exercise techniques (group 3) most frequently used for the treatment of these pathologies; seven sessions of craniosacral therapy (group 2) as corrective and preventive in possible alterations during infant neurodevelopment and finally seven sessions simulating craniosacral therapy on a placebo group (group 1) as a control of the treatments used. | Procedure or surgery | Patients receiving balance and coordination therapy, Patients receiving craniosacral therapy, Patients receiving placebo |
Primary outcome
"Series of questions to the children's parents"
Time frame: two weeks
A series of questions were asked to the children's parents in a virtual questionnaire on physical characteristics, previous health assessments and observations of their balance and coordination in front of their children
"Battelle Developmental Inventory" (BDI)
Time frame: two weeks
On the other hand, the school teachers examined neurobehavioral aspects of the students using the "Battelle Developmental Inventory" (BDI), which evaluates five areas of development (personal/social, adaptive, motor, communicative and cognitive) between 2 and 8 years of age. The results are assigned in age-adjusted percentages, classified as: low (0-49%), normal (50-79%) and high (80-100%). Low and high values are considered impairments in one or more of the areas evaluated
5 secondary outcomes
"Number of participants in each therapy group"
Time frame: Seven weeks
"The effectiveness values of the therapies for each group"
Time frame: seven weeks
"Pre-treatment Battelle Scale"
Time frame: two weeks
"Post-treatment Battelle Scale"
Time frame: two weeks
"percentages of satisfaction from 1st to the 7th therapy sessions"
Time frame: seven weeks
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 29 Dec 2021.
- Individual participant dataSharing planned: No. The request for the data will be studied and considered upon prior and justified 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.
Irene Cantarero Carmona study chair
Universidad de Córdoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A series of questions were asked to the children's parents in a virtual questionnaire, neurobehavioral aspects of the students using the "Battelle Developmental Inventory" (BDI) and Therapy sessions in people with Healthy Children, run by Clinica Gema Leon at 1 site in Spain.
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 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2021. 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 Spain. 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. Some participants in this study may receive a placebo. 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?
"Series of questions to the children's parents" (time frame: two 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 29 Dec 2021; AzTrials last refreshed its copy on 1 Nov 2026.