- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06670092
Effect of Vojta Therapy on Motor Control in Children With Attention Deficit Hyperactivity Disorder
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Madrid
-
Alcorcón, Madrid, Spain, 28922
- Universidad Rey Juan Carlos
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental group
This group is treated according to Vojta therapy
|
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. |
|
Other: Control group
This group does not receive treatment
|
No intervetion group
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
15 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Paediatric Balance Scale
Time Frame: 15 minutes
|
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.
|
15 minutes
|
|
Bruininks-Oseretsky Test (abbreviated version)
Time Frame: 10 minutes
|
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.
|
10 minutes
|
|
Paediatric Quality of Life Questionnaire
Time Frame: 10 minutes
|
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.
|
10 minutes
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09/2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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