Effectiveness of Manual Therapy in the Treatment of Attention Deficit Hyperactivity Disorder (MT-ADHD)

JJ JIMENEZ-REJANO

Status: Not yet enrolling

Conditions: Attention Deficit Hyperactivity Disorder (ADHD)

Treatments: Procedure: Procedure: craniosacral therapy techniques.; Procedure: Placebo Group

Study type: Interventional

Funder types: Other

Identifiers

NCT07029425

USeville-PFB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups, including a placebo group

Experimental: craniosacral therapy techniques.

Experimental group

Description:

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.

Treatment:

Procedure: Procedure: craniosacral therapy techniques.

Control: placebo comparator.

Placebo Comparator group

Description:

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.

Treatment:

Procedure: Placebo Group