Mother of a Child With Cerebral PalsyNCT06970769
Effect of Vagus Nerve Stimulation and Breathing Exercise on the Autonomic Nervous System
A study testing Vagus nerve stimulation and Deep Breathing Exercises in people with Mother of a Child With Cerebral Palsy, run by Atlas University at 1 site in Turkey (Türkiye).
Trial summary
This project will compare the effects of intraaural vagus nerve stimulation and deep breathing exercises on the autonomic nervous system in mothers of children with cerebral palsy. This approach will allow researchers to evaluate the effects of these practices on the autonomic nervous system. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mother of a Child With Cerebral Palsy
- What is being tested?
- Vagus nerve stimulation and Deep Breathing Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Aug 2024to 30 Apr 2025
- 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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Having a child diagnosed with cerebral palsy
- The child must be between 4-18 years old
- The mother must be between 18-50 years old
- The mother to be studied must be literate
Who cannot join
- Providing care for an elderly, chronically ill or disabled relative;
- Having a history of chronic disease such as diabetes, cardiovascular or pulmonary disease, kidney disease, musculoskeletal disorders or any psychiatric disorder
- Caring for another child under the age of two
- Having another child at home who needs special health care
- Not volunteering to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İstanbul Atlas University
Istanbul, Kağıthane, 34040
About this study
Official title: Comparison of the Effects of Vagus Nerve Stimulation and Breathing Exercise on the Autonomic Nervous System in Mothers of Children With Cerebral Palsy
This project will compare the effects of intraaural vagus nerve stimulation and deep breathing exercises on the autonomic nervous system in mothers of children with cerebral palsy. This approach will allow researchers to evaluate the effects of these practices on the autonomic nervous system.
The study is planned to include 38 mothers of children with cerebral palsy between the ages of 18-50. Participants will be informed about the purpose of the study and will provide written informed consent to verify voluntary participation. Participants will be randomly assigned to one of two groups: "vagus nerve stimulation" and "deep breathing exercises." Autonomic nervous system, pain, depression, sleep quality, and caregiver burden will be assessed before and after the study.
Read the detailed description
The autonomic nervous system plays an important role in maintaining the physiological and psychological balance of individuals. Therefore, irregularities in the autonomic nervous system can negatively affect daily life activities and quality of life. In mothers of children with cerebral palsy, the stress, sleep problems and physical loads brought about by the caregiving process can disrupt the autonomic nervous system functions. In this context, interventions aimed at supporting autonomic balance are gaining importance. This project will compare the effectiveness of intraaural vagus nerve stimulation and deep breathing exercises used in clinical settings on the autonomic nervous system in healthy individuals and will allow researchers to evaluate the effects of these methods on physiological functions.
The study plans to include 38 mothers of children with cerebral palsy between the ages of 18-50. Participants will be informed about the purpose of the study and will provide written informed consent to confirm voluntary participation. Participants will be randomly assigned to one of two groups: "vagus nerve stimulation" and "deep breathing exercises." Autonomic nervous system, pain, depression, sleep quality and caregiver burden will be assessed before and after the study. Data analysis was performed using SPSS v.26 (SPSS Inc., USA) software. χ² test was applied in the analysis of qualitative variables. For data that did not show a normal distribution or were ordinal, Wilcoxon test was preferred for within-group comparisons, and Mann-Whitney U test was preferred for between-group comparisons. For numerical data that showed a normal distribution, Paired Samples T-Test was used for within-group comparisons, and Independent Samples T-Test was used for between-group comparisons. Effect size values were classified as 'negligible' in the range of 0-0.19, 'small' in the range of 0.20-0.49, 'medium' in the range of 0.50-0.79, and 'large' in the range of 0.80 and above. The significance level was determined as p<0.05 in all statistical tests performed.
- Conditions
- Mother of a Child With Cerebral Palsy
- Being tested
- Vagus nerve stimulation, Deep Breathing Exercises
- Keywords
- cerebral palsy, mother, autonomic nerve system, vagus, breathing exercises, depression, pain, sleep quality
- Medical subject headings
- Cerebral Palsy, Depression, Pain, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vagus nerve stimulationOther
In our study, the auricular branch in the pinna was superficially stimulated with a TENS-based vagustim device for non-invasive vagus nerve stimulation. The application was performed in regular sessions with a physiotherapist according to the recorded protocol. This deactivation aimed at modulation of the autonomic nervous system via the vagus nerve.
Deep Breathing ExercisesOther
In the study, the participants who were given deep breathing exercises were taught the correct technique in a semi-sitting position. During the exercises, deep breathing and relaxation periods were applied for certain periods. The respiratory rhythm was arranged as controlled inspiration and expiration. The participants were given an application practice so that they could continue the exercise at home.
| Study group | Role | What they receive |
|---|---|---|
| Auricular Nerve Stimulation | Experimental | The auricular branch of the vagus nerve can be superficially stimulated from the external ear by non-invasive access. This method is applied without any surgical procedure by means of TENS add-on devices. This technique, which is widely used in epilepsy, pain and headache, increases the intensity of pain and reduces mechanical sensitivity. Receives: Other: Vagus nerve stimulation |
| Deep breathing exercise | Experimental | Deep breathing exercise aimed to improve stress, sleep problems and physiological balance by increasing parasympathetic activity on the autonomic nervous system of mothers in our study. Diaphragmatic breathing technique was taught to participants who applied deep breathing exercise in a comfortable position. Exercises were planned to be performed with a certain rhythm of inspiration and expiration times. Participants were trained with repetitions so that they could continue the application at home. The exercises were applied regularly in the home environment for the specified period. Receives: Other: Deep Breathing Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross motor functional classification (GMFCS)
It can be found by palisino for the operation of gross motor function in children with cerebral palsy, it is a scale with proven validity and reliability. It is specially prepared for children with cerebral palsy up to 12 years of age, depending on the independence and independent movements allowed in movements such as transfer and mobilization, the limitation in functionality and the use of assistive devices. age, 12-15 years, 15-18 years). The GMFCS categorizes motor function into five levels (I to V), where Level I indicates the highest level of independence and functional ability, and Level V represents the most severe motor limitations. Therefore, higher levels correspond to poorer outcomes in terms of gross motor function.
Measured: Baseline (prior to intervention)
beck depression scale
The Turkish version of the Beck Depression Scale, which has been validated and reliable in Turkish, was used to assess depression. Each question is scored between 0-3 and consists of 4 items. The survey consists of 21 questions. The total score is calculated as 63 points by evaluating symptoms and behavior. The scale includes; pessimism, sleep disorders, self-hatred, mood, desire to punish oneself, dissatisfaction, guilt, sense of failure, sense of punishment, somatic disorder, exhaustion, fatigue, body perception status change, self-blame, crying spells, determination of workability, stress, social isolation, difficulty in decision making, eating status, weight loss and sexual issues. The higher the final score of the survey, the higher the level of depression. According to the scale scores; 0-9 is interpreted as "no or minimal depression", 10-16 as "mild depression", 17-29 as "moderate depression", and 30-63 points as "severe depression".
Measured: 3 week
Caregiving Burden Scale
The Caregiving Burden Scale, developed to assess the perceived burden in caregivers, was created by Zarit and his colleagues in 1980. The Turkish validity and reliability study was conducted by İnci and Erdem. The scale is a 22-item, 5-point Likert-type scale that measures the social and emotional difficulties experienced during the care process. Each item is scored between 0-4, and the total score ranges from 0 to 88. As the score increases, the perceived care burden increases proportionally. According to the evaluation results; 0-20 is considered low or almost no burden, 21-40 is considered mild-moderate burden, 41-60 is considered moderate-high burden, and 61-88 is considered excessive burden. In the reliability study of the Turkish form, the Cronbach Alpha coefficient was determined as 0.95, and the test-retest reliability was found to be 0.90. In addition, according to factor analysis, the scale has a one-dimensional structure and effectively reflects the stress level.
Measured: 3 week
NORDIC musculoskeletal system questionnaire
The Scandinavian Musculoskeletal System Questionnaire was employed to identify painful regions in the participants. This tool evaluates musculoskeletal complaints in areas such as the lower back, neck, shoulders, and other body regions. It offers reliable information regarding the onset, prevalence, and consequences of symptoms experienced over the past 12 months and the previous 7 days across nine categorized anatomical regions (feet/ankles, knees, thighs, hips, hands/wrists, lower back, elbows, upper back, shoulders, and neck). The questionnaire can be completed independently or through an interviewer-administered format. The NMQ-E records the presence of symptoms in each region using binary (yes/no) responses, and results are reported as percentages. Higher percentages indicate a greater prevalence of musculoskeletal complaints in the corresponding region, reflecting poorer outcomes.
Measured: 3 week
Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) was used to assess the sleep quality of the participants. It is a questionnaire that evaluates sleep quality and current sleep disorders within a one-month period. The PSQI consists of 19 items and is scored under 7 components. These components are subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disorders, use of sleeping pills, and daytime dysfunction. The participant obtains a general sleep quality score by summing the scores from the seven components . Apart from these components, there are 5 additional questions in the rest of the questionnaire that must be answered by the participant's bed partner if the participant has one. However, these 5 questions are not used in the total score, but are used in clinical interpretation . All 19 questions are scored between 0 and 3. A score of 0 for each component indicates that there is no difficulty with that question, while a score of 3 indicates t
Measured: 3 week
Autonomic Nervous System Assessment (Polar H10)
The Polar H10 device is a reliable and sensitive sensor that evaluates autonomic nervous system (ANS) functions via heart rate variability (HRV). In the Cubios system, multiple HRV parameters-including HR (bpm), RMSSD (ms), SDNN (ms), LF (ms²), and HF (ms²)-are integrated into a single analytical model to assess overall autonomic nervous system (ANS) function. Although each parameter has a different measurement unit, the system processes them collectively to produce a unified outcome. Therefore, these measures are not reported individually but are synthesized into a composite ANS balance evaluation.
Measured: 3 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start29 Aug 2024
- Primary completion30 Mar 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mother of a Child With Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two groups: "vagus nerve stimulation" and "deep breathing exercises." Autonomic nervous system, pain, depression, sleep quality and caregiver burden will be assessed before and after the study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze Demircioğlu, Atlas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06970769
- Sponsor's protocol ID
- 2025-ATLAS-MSEHF-003
- Status last verified
- Jul 2024
- First submitted
- 28 Apr 2025
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data (IPD) from this study. All collected data will be used solely for the purpose of analyzing study outcomes and will remain confidential. This approach is taken to ensure the privacy and confidentiality of participant information.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Vagus Nerve Stimulation and Breathing Exercise on the Autonomic Nervous System in Mothers of Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06970769
- Acronym / sponsor ID
- 2025-ATLAS-MSEHF-003
- Conditions
- Mother of a Child With Cerebral Palsy
- Keywords
- cerebral palsy, mother, autonomic nerve system, vagus, breathing exercises, depression, pain, sleep quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Atlas UniversityUniversity, hospital or other
- Study start
- 29 Aug 2024 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 14 May 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.
This project will compare the effects of intraaural vagus nerve stimulation and deep breathing exercises on the autonomic nervous system in mothers of children with cerebral palsy. This approach will allow researchers to evaluate the effects of these practices on the autonomic nervous system.
The study is planned to include 38 mothers of children with cerebral palsy between the ages of 18-50. Participants will be informed about the purpose of the study and will provide written informed consent to verify voluntary participation. Participants will be randomly assigned to one of two groups: "vagus nerve stimulation" and "deep breathing exercises." Autonomic nervous system, pain, depression, sleep quality, and caregiver burden will be assessed before and after the study.
Detailed description
The autonomic nervous system plays an important role in maintaining the physiological and psychological balance of individuals. Therefore, irregularities in the autonomic nervous system can negatively affect daily life activities and quality of life. In mothers of children with cerebral palsy, the stress, sleep problems and physical loads brought about by the caregiving process can disrupt the autonomic nervous system functions. In this context, interventions aimed at supporting autonomic balance are gaining importance. This project will compare the effectiveness of intraaural vagus nerve stimulation and deep breathing exercises used in clinical settings on the autonomic nervous system in healthy individuals and will allow researchers to evaluate the effects of these methods on physiological functions.
The study plans to include 38 mothers of children with cerebral palsy between the ages of 18-50. Participants will be informed about the purpose of the study and will provide written informed consent to confirm voluntary participation. Participants will be randomly assigned to one of two groups: "vagus nerve stimulation" and "deep breathing exercises." Autonomic nervous system, pain, depression, sleep quality and caregiver burden will be assessed before and after the study. Data analysis was performed using SPSS v.26 (SPSS Inc., USA) software. χ² test was applied in the analysis of qualitative variables. For data that did not show a normal distribution or were ordinal, Wilcoxon test was preferred for within-group comparisons, and Mann-Whitney U test was preferred for between-group comparisons. For numerical data that showed a normal distribution, Paired Samples T-Test was used for within-group comparisons, and Independent Samples T-Test was used for between-group comparisons. Effect size values were classified as 'negligible' in the range of 0-0.19, 'small' in the range of 0.20-0.49, 'medium' in the range of 0.50-0.79, and 'large' in the range of 0.80 and above. The significance level was determined as p<0.05 in all statistical tests performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two groups: "vagus nerve stimulation" and "deep breathing exercises." Autonomic nervous system, pain, depression, sleep quality and caregiver burden will be assessed before and after the study.
| Arm | Type | Receives |
|---|---|---|
| Auricular Nerve Stimulation | Experimental | Other: Vagus nerve stimulationThe auricular branch of the vagus nerve can be superficially stimulated from the external ear by non-invasive access. This method is applied without any surgical procedure by means of TENS add-on devices. This technique, which is widely used in epilepsy, pain and headache, increases the intensity of pain and reduces mechanical sensitivity. |
| Deep breathing exercise | Experimental | Other: Deep Breathing ExercisesDeep breathing exercise aimed to improve stress, sleep problems and physiological balance by increasing parasympathetic activity on the autonomic nervous system of mothers in our study. Diaphragmatic breathing technique was taught to participants who applied deep breathing exercise in a comfortable position. Exercises were planned to be performed with a certain rhythm of inspiration and expiration times. Participants were trained with repetitions so that they could continue the application at home. The exercises were applied regularly in the home environment for the specified period. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Having a child diagnosed with cerebral palsy
- The child must be between 4-18 years old
- The mother must be between 18-50 years old
- The mother to be studied must be literate
Key exclusion criteria (5 listed)
- Providing care for an elderly, chronically ill or disabled relative;
- Having a history of chronic disease such as diabetes, cardiovascular or pulmonary disease, kidney disease, musculoskeletal disorders or any psychiatric disorder
- Caring for another child under the age of two
- Having another child at home who needs special health care
- Not volunteering to participate in the study
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 |
|---|---|---|
| Vagus nerve stimulationIn our study, the auricular branch in the pinna was superficially stimulated with a TENS-based vagustim device for non-invasive vagus nerve stimulation. The application was performed in regular sessions with a physiotherapist according to the recorded protocol. This deactivation aimed at modulation of the autonomic nervous system via the vagus nerve. | Other | Auricular Nerve Stimulation |
| Deep Breathing ExercisesIn the study, the participants who were given deep breathing exercises were taught the correct technique in a semi-sitting position. During the exercises, deep breathing and relaxation periods were applied for certain periods. The respiratory rhythm was arranged as controlled inspiration and expiration. The participants were given an application practice so that they could continue the exercise at home. | Other | Deep breathing exercise |
Primary outcome
Gross motor functional classification (GMFCS)
Time frame: Baseline (prior to intervention)
It can be found by palisino for the operation of gross motor function in children with cerebral palsy, it is a scale with proven validity and reliability. It is specially prepared for children with cerebral palsy up to 12 years of age, depending on the independence and independent movements allowed in movements such as transfer and mobilization, the limitation in functionality and the use of assistive devices. age, 12-15 years, 15-18 years). The GMFCS categorizes motor function into five levels (I to V), where Level I indicates the highest level of independence and functional ability, and Level V represents the most severe motor limitations. Therefore, higher levels correspond to poorer outcomes in terms of gross motor function.
beck depression scale
Time frame: 3 week
The Turkish version of the Beck Depression Scale, which has been validated and reliable in Turkish, was used to assess depression. Each question is scored between 0-3 and consists of 4 items. The survey consists of 21 questions. The total score is calculated as 63 points by evaluating symptoms and behavior. The scale includes; pessimism, sleep disorders, self-hatred, mood, desire to punish oneself, dissatisfaction, guilt, sense of failure, sense of punishment, somatic disorder, exhaustion, fatigue, body perception status change, self-blame, crying spells, determination of workability, stress, social isolation, difficulty in decision making, eating status, weight loss and sexual issues. The higher the final score of the survey, the higher the level of depression. According to the scale scores; 0-9 is interpreted as "no or minimal depression", 10-16 as "mild depression", 17-29 as "moderate depression", and 30-63 points as "severe depression".
Caregiving Burden Scale
Time frame: 3 week
The Caregiving Burden Scale, developed to assess the perceived burden in caregivers, was created by Zarit and his colleagues in 1980. The Turkish validity and reliability study was conducted by İnci and Erdem. The scale is a 22-item, 5-point Likert-type scale that measures the social and emotional difficulties experienced during the care process. Each item is scored between 0-4, and the total score ranges from 0 to 88. As the score increases, the perceived care burden increases proportionally. According to the evaluation results; 0-20 is considered low or almost no burden, 21-40 is considered mild-moderate burden, 41-60 is considered moderate-high burden, and 61-88 is considered excessive burden. In the reliability study of the Turkish form, the Cronbach Alpha coefficient was determined as 0.95, and the test-retest reliability was found to be 0.90. In addition, according to factor analysis, the scale has a one-dimensional structure and effectively reflects the stress level.
NORDIC musculoskeletal system questionnaire
Time frame: 3 week
The Scandinavian Musculoskeletal System Questionnaire was employed to identify painful regions in the participants. This tool evaluates musculoskeletal complaints in areas such as the lower back, neck, shoulders, and other body regions. It offers reliable information regarding the onset, prevalence, and consequences of symptoms experienced over the past 12 months and the previous 7 days across nine categorized anatomical regions (feet/ankles, knees, thighs, hips, hands/wrists, lower back, elbows, upper back, shoulders, and neck). The questionnaire can be completed independently or through an interviewer-administered format. The NMQ-E records the presence of symptoms in each region using binary (yes/no) responses, and results are reported as percentages. Higher percentages indicate a greater prevalence of musculoskeletal complaints in the corresponding region, reflecting poorer outcomes.
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 3 week
The Pittsburgh Sleep Quality Index (PSQI) was used to assess the sleep quality of the participants. It is a questionnaire that evaluates sleep quality and current sleep disorders within a one-month period. The PSQI consists of 19 items and is scored under 7 components. These components are subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disorders, use of sleeping pills, and daytime dysfunction. The participant obtains a general sleep quality score by summing the scores from the seven components . Apart from these components, there are 5 additional questions in the rest of the questionnaire that must be answered by the participant's bed partner if the participant has one. However, these 5 questions are not used in the total score, but are used in clinical interpretation . All 19 questions are scored between 0 and 3. A score of 0 for each component indicates that there is no difficulty with that question, while a score of 3 indicates t
Autonomic Nervous System Assessment (Polar H10)
Time frame: 3 week
The Polar H10 device is a reliable and sensitive sensor that evaluates autonomic nervous system (ANS) functions via heart rate variability (HRV). In the Cubios system, multiple HRV parameters-including HR (bpm), RMSSD (ms), SDNN (ms), LF (ms²), and HF (ms²)-are integrated into a single analytical model to assess overall autonomic nervous system (ANS) function. Although each parameter has a different measurement unit, the system processes them collectively to produce a unified outcome. Therefore, these measures are not reported individually but are synthesized into a composite ANS balance evaluation.
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 18 Jul 2025.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data (IPD) from this study. All collected data will be used solely for the purpose of analyzing study outcomes and will remain confidential. This approach is taken to ensure the privacy and confidentiality of participant information.
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 Vagus nerve stimulation and Deep Breathing Exercises in people with Mother of a Child With Cerebral Palsy, run by Atlas University at 1 site in Turkey (Türkiye).
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 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: finished, as of the sponsor's last update on 18 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 Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gross motor functional classification (GMFCS) (time frame: Baseline (prior to intervention)). The study lists 6 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 18 Jul 2025.