Effect of Vojta Therapy on Motor Control in Children With Attention Deficit Hyperactivity Disorder

NCT06670092 | Completed DMC

• 1 other identifier: 09/2024
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

Attention-Deficit/Hyperactivity Disorder; Vojta Therapy; balance; postural control; visual motor coordination; manipulative skills

Outcome Measures

Primary Outcomes (1)

• 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

  15 minutes

Secondary Outcomes (3)

• Paediatric Balance Scale

  15 minutes

• Bruininks-Oseretsky Test (abbreviated version)

  10 minutes

• Paediatric Quality of Life Questionnaire

  10 minutes

Study Arms (2)

Experimental group

EXPERIMENTAL

This group is treated according to Vojta therapy

Other: Vojta Therapy

Control group

OTHER

This group does not receive treatment

Other: No intervetion

Interventions

Vojta Therapy OTHER

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.

Experimental group

No intervetion OTHER

No intervetion group

Also known as: No intervention group

Control group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Rey Juan Carlos: lead

Study Sites (1)

Universidad Rey Juan Carlos

Alcorcón, Madrid, 28922, Spain

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 1, 2024
• Study Start: November 30, 2024
• Primary Completion: January 20, 2025
• Study Completion: March 3, 2025
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)