Ireland
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Starting soon Not applicable

Effectiveness of Manual Therapy in the Treatment of Attention Deficit Hyperactivity Disorder

NCT07029425 · tracked via the Priya Life Science Spain tracker
Sponsor
JJ JIMENEZ-REJANO
Phase
Not applicable
Started
2025-10-01
Last updated
2025-06-27

Condition(s) studied

Attention Deficit Hyperactivity Disorder (ADHD)

Investigational drug(s) / intervention(s)

Procedure: craniosacral therapy techniques.Placebo Group

Procedure: craniosacral therapy techniques.: Participants in the experimental group will receive Manual Therapy (MT) designed for this study, which will include craniosacral therapy techniques. The sessions will last 40 minutes and will be conducted twice a week for the first 4 weeks, followed by once a week for the final 4 weeks.

Placebo Group: The placebo group will receive a dummy treatment with a duration of 40min, twice a week for the firt 4 week, follwed by once a week for the final 4 week.

Study summary

The main objective is to determine whether Manual Therapy (MT), in addition to conventional treatment, is more effective in improving ADHD symptoms than the application of conventional treatment alone.

Eligibility

Sex
ALL
Min age
6 Years
Max age
12 Years
Healthy volunteers
No
Inclusion Criteria: * Confirmed ADHD diagnosis according to DSM-5 criteria. * Children and adolescents aged 6 to 12 years. * Availability to attend all Manual Therapy (MT) sessions. * Informed consent signed by legal guardians. Exclusion Criteria: * Severe concomitant psychiatric or neurological disorders (e.g., epilepsy, severe autism spectrum disorder, schizophrenia). * Medical conditions that contraindicate MT (e.g., fractures, severe scoliosis, connective tissue diseases). * Recent use of or changes in ADHD medication within the past 4 weeks. * Simultaneous participation in other interventional studies.

Primary outcome measure(s)

  • Symptoms of ADHD (Parents Rating Scale) — At the star of the study (at basilne, 0 week), After the 2nd session (at the end of the first week), after 12th session (at the end of the eight week) and 4 months from the last session (24th week).
    Conners Parents Rating Scale. 48 items 0 = Never, 1 = Sometimes, 2 = Often, and 3 = Very Often. Scores 0-144. Scores greater than or equal to 59 = normal range, Scores 60-64 = mildly elevated symptom severity, Scores 65-69 = moderately elevated severity Scores \> 70 = presence of highly elevated severity.
  • Symptoms of ADHD (Teacher Rating Scale) — At the star of the study (at basilne, 0 week), After the 2nd session (at the end of the first week), after 12th session (at the end of the eight week) and 4 months from the last session (24th week).
    Conners Teacher Rating Scale. 28 items. 0 = Never, 1 = Sometimes, 2 = Often, and 3 = Very Often. Scores 0-84. Scores greater than or equal to 59 = normal range, Scores 60-64 = mildly elevated symptom severity, Scores 65-69 = moderately elevated severity Scores \> 70 = presence of highly elevated severity.

Trial sites (1)

FacilityCityRegionStatus
Grupo de Investigación Área de Fisioterapia CTS 305 - Universidad de Sevilla, Sevilla, Spain 41009 Alcalá de Henares Madrid

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07029425 on ClinicalTrials.gov ↗ ← All trials in Spain