Attention Deficit Disorder With HyperactivityNCT06670092
Effect of Vojta Therapy on Motor Control in Children With Attention Deficit Hyperactivity Disorder
A study testing Vojta Therapy and No intervetion in people with Attention Deficit Disorder With Hyperactivity, run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial summary
ADHD is generally associated with significant comorbidities including motor disorders in up to 96% of cases. Within these, disturbances of balance and motor coordination that interfere with school learning and daily activities are present in 47% of school children with ADHD. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- What is being tested?
- Vojta Therapy and No intervetion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 30 Nov 2024to 3 Mar 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Have a diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) of the combined or hyperkinetic type.
- Be between 6 and 12 years of age.
- Be under treatment with methylphenidate.
- IQ of 100 or higher.
- Have a normal neurological examination.
- Not dysmorphic.
- Not have received specific physiotherapy treatment for the improvement of balance and postural control in the two months prior to inclusion in the study.
Who cannot join
- Present a diagnosis of ADHD comorbid with other neuropsychiatric pathologies.
- Have a history of neurological or musculoskeletal disorders that are linked to a deficit in balance and/or postural control.
- Be under treatment with atomoxetine.
Trial locations and contacts
1 site in 1 country.
About this study
ADHD is generally associated with significant comorbidities including motor disorders in up to 96% of cases. Within these, disturbances of balance and motor coordination that interfere with school learning and daily activities are present in 47% of school children with ADHD. Therefore, the aim of this research is to determine whether Vojta therapy is beneficial for the improvement of balance, postural control, hand-eye coordination and manipulative motor skills in children with ADHD, hyperactive and/or combined, aged 6-12 years.
- Being tested
- Vojta Therapy, No intervetion
- Keywords
- Attention-Deficit/Hyperactivity Disorder, Vojta Therapy, balance, postural control, visual motor coordination, manipulative skills
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vojta TherapyOther
The intervention is carried out using Vojta therapy for one month, with one session per day, 5 days a week. This therapy is carried out by an expert physiotherapist. Vojta therapy is a non-experimental, painless, non-invasive therapy with no adverse effects, which is based on triggering repeated motor reactions or innate movement patterns (reflex locomotion patterns) in the trunk and limbs based on defined stimuli and starting from specific postures.
Both groups will undertake a pre-treatment assessment, a post-treatment assessment at the end of the one-month intervention period, and a final follow-up assessment one month after the end of the intervention.
No intervetionOther
Also called No intervention group
No intervetion group
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | This group is treated according to Vojta therapy Receives: Other: Vojta Therapy |
| Control group | Other | This group does not receive treatment Receives: Other: No intervetion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory organisation test (NEUROCOM dynamic posturology)
This test is a commonly used research tool in the assessment of the sensory organisation of postural control and has previously been used in children. The system's force platform provides data on the movement of the centre of gravity. Both the platform and the environment can move in response to the anteroposterior displacement of the child's body under certain conditions of sensory override or conflict. The child is asked to stand upright, barefoot, with arms alongside the body, feet placed in a certain position on the platform, for 20sec, trying to remain as stable as possible during the 3 trials of each of the 6 conditions of the SOT. For their safety, the child shall be restrained by a harness. In each test, the system compares the child's displacement with its theoretical limits of stability, generating a score. The higher the value, the better the stability. The software also calculates an overall score from the scores obtained in each of the 6 conditions
Measured: 15 minutes
Secondary outcomes (3)
Paediatric Balance Scale
This is a clinical scale used to assess balance in children aged 5 to 15 years. It consists of 14 items (each rated at 0-4 points), is easy to perform, does not require specialised equipment and takes less than 15 minutes to complete. It is considered the paediatric alternative to the Berg Balance Scale in school-aged children with mild to moderate motor impairment, with good intra- and inter-observer reliability.
Measured: 15 minutes
Bruininks-Oseretsky Test (abbreviated version)
This test assesses agility and speed in running, balance, bilateral coordination, strength, coordination and response speed of the upper limb, visual-motor control and speed and dexterity of the upper limb. This test has been used in the ADHD population.
Measured: 10 minutes
Paediatric Quality of Life Questionnaire
It is a widely studied and used instrument, designed for children, which has a generic module for paediatric quality of life, which also has specific modules for various chronic diseases and clinical situations. The different existing versions will be used depending on the age of the child (questionnaire for children aged 5 to 7 years and questionnaire for children aged 8 to 12 years) validated and translated into Spanish. Both questionnaires can be administered to the child or to the parents.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start30 Nov 2024
- Primary completion20 Jan 2025
- Study completion3 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Disorder With HyperactivityStudies 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
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josue Fernandez Carnero, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06670092
- Sponsor's protocol ID
- 09/2024
- Status last verified
- Mar 2025
- First submitted
- 31 Oct 2024
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vojta Therapy on Motor Control in Children With Attention Deficit Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT06670092
- Acronym / sponsor ID
- 09/2024
- Keywords
- Attention-Deficit/Hyperactivity Disorder, Vojta Therapy, balance, postural control, visual motor coordination, manipulative skills
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- 30 Nov 2024 (actual)
- Primary completion
- 20 Jan 2025 (actual)
- Study completion
- 3 Mar 2025 (actual)
- First posted
- 1 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.
ADHD is generally associated with significant comorbidities including motor disorders in up to 96% of cases. Within these, disturbances of balance and motor coordination that interfere with school learning and daily activities are present in 47% of school children with ADHD. Therefore, the aim of this research is to determine whether Vojta therapy is beneficial for the improvement of balance, postural control, hand-eye coordination and manipulative motor skills in children with ADHD, hyperactive and/or combined, aged 6-12 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Vojta TherapyThis group is treated according to Vojta therapy |
| Control group | Other | Other: No intervetionThis group does not receive treatment |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Have a diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) of the combined or hyperkinetic type.
- Be between 6 and 12 years of age.
- Be under treatment with methylphenidate.
- IQ of 100 or higher.
- Have a normal neurological examination.
Key exclusion criteria (3 listed)
- Present a diagnosis of ADHD comorbid with other neuropsychiatric pathologies.
- Have a history of neurological or musculoskeletal disorders that are linked to a deficit in balance and/or postural control.
- Be under treatment with atomoxetine.
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 |
|---|---|---|
| Vojta TherapyThe intervention is carried out using Vojta therapy for one month, with one session per day, 5 days a week. This therapy is carried out by an expert physiotherapist. Vojta therapy is a non-experimental, painless, non-invasive therapy with no adverse effects, which is based on triggering repeated motor reactions or innate movement patterns (reflex locomotion patterns) in the trunk and limbs based on defined stimuli and starting from specific postures. Both groups will undertake a pre-treatment assessment, a post-treatment assessment at the end of the one-month intervention period, and a final follow-up assessment one month after the end of the intervention. | Other | Experimental group |
| No intervetionAlso: No intervention groupNo intervetion group | Other | Control group |
Primary outcome
Sensory organisation test (NEUROCOM dynamic posturology)
Time frame: 15 minutes
This test is a commonly used research tool in the assessment of the sensory organisation of postural control and has previously been used in children. The system's force platform provides data on the movement of the centre of gravity. Both the platform and the environment can move in response to the anteroposterior displacement of the child's body under certain conditions of sensory override or conflict. The child is asked to stand upright, barefoot, with arms alongside the body, feet placed in a certain position on the platform, for 20sec, trying to remain as stable as possible during the 3 trials of each of the 6 conditions of the SOT. For their safety, the child shall be restrained by a harness. In each test, the system compares the child's displacement with its theoretical limits of stability, generating a score. The higher the value, the better the stability. The software also calculates an overall score from the scores obtained in each of the 6 conditions
3 secondary outcomes
Paediatric Balance Scale
Time frame: 15 minutes
Bruininks-Oseretsky Test (abbreviated version)
Time frame: 10 minutes
Paediatric Quality of Life Questionnaire
Time frame: 10 minutes
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 7 Mar 2025.
- Individual participant dataSharing planned: Yes
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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 Vojta Therapy and No intervetion in people with Attention Deficit Disorder With Hyperactivity, run by Universidad Rey Juan Carlos 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 7 inclusion and 3 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 7 Mar 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 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. 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?
Sensory organisation test (NEUROCOM dynamic posturology) (time frame: 15 minutes). 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 7 Mar 2025.