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

NCT07029425 | Not Yet Recruiting

• 1 other identifier: USeville-PFB
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Keywords

Attention Deficit Hyperactivity Disorder; manual therapy; pediatrics

Outcome Measures

Primary Outcomes (2)

• Symptoms of ADHD (Parents Rating Scale)

  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.

  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).

• Symptoms of ADHD (Teacher Rating Scale)

  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.

  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).

Secondary Outcomes (1)

• 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).

Study Arms (2)

Experimental: craniosacral therapy techniques.

EXPERIMENTAL

Experimental: 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.

Procedure: Procedure: craniosacral therapy techniques.

Control: placebo comparator.

PLACEBO COMPARATOR

Sham Comparator: 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.

Procedure: Placebo Group

Interventions

Procedure: craniosacral therapy techniques. PROCEDURE

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.

Experimental: craniosacral therapy techniques.

Placebo Group PROCEDURE

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.

Control: placebo comparator.

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• JJ JIMENEZ-REJANO: lead

Study Sites (1)

Grupo de Investigación Área de Fisioterapia CTS 305 - Universidad de Sevilla, Sevilla, Spain 41009

Alcalá de Henares, Madrid, 28804, Spain

Location

Related Publications (20)

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MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Paloma Felipe-Ballesteros, PT

CONTACT

+34 672783021; paloma.felipe@edu.uah.es

Paloma Felipe-Ballesteros, PT

CONTACT

+34672783021; paloma.felipe@edu.uah.es

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: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: June 19, 2025
• Study Start: October 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 27, 2025

Record last verified: 2025-06

Locations

ES (1)