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

Not Applicable

Not yet recruiting

• Conditions: Attention Deficit Hyperactivity Disorder (ADHD)

• Registration Number: NCT07029425
• Lead Sponsor: JJ JIMENEZ-REJANO

Brief 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.

Detailed Description

Background ADHD is a disorder that affects attention, behavior control, and emotions in children. Although medication and behavioral therapy can help, not all children respond well or may experience side effects, which leads to the search for alternative options. This disorder affects the daily lives of both the child and their family, and in adulthood, it can cause emotional, social, and work-related problems. Treatment usually includes medication, cognitive-behavioral therapy, parent training, and techniques such as mindfulness. A newer option is manual therapy (MT), which uses massage and craniosacral therapy to support the nervous system and improve emotional and behavioral regulation. Although some studies have shown promising results, more research is needed to confirm its effectiveness.

Materials and Methods: A randomized clinical trial will be conducted. The minimum sample size required for statistical significance is 60 subjects, divided into two groups with 30 participants each. The primary variable will be hyperactivity and attention deficit, assessed using the Conners Parent Rating Scale and the Conners Teacher Rating Scale. The secondary variable will be mood, measured using a facial expression scale.

Objetives To determine whether the addition of manual therapy to conventional treatment is more effective in improving ADHD symptoms than conventional treatment alone.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-11
• Study First Submitted QC: 2025-06-11
• Study First Posted: 2025-06-19
• Last Update Submitted: 2025-06-24
• Last Update Posted: 2025-06-27
• Study Start: 2025-10-01
• Primary Completion: 2026-05-01
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Mood	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).	Facial Expression Scale. It represents expressions from sadness (scored with 1) to happiness (scored with 4).

Trial Locations

Locations (1)

Grupo de Investigación Área de Fisioterapia CTS 305 - Universidad de Sevilla, Sevilla, Spain 41009; 🇪🇸 Alcalá De Henares, Madrid, Spain