Health TrialsbyHealthPanel

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

ConditionAttention Deficit Hyperactivity Disorder (ADHD)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorJJ JIMENEZ-REJANO

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Procedure: craniosacral therapy techniques.

    Procedure/Surgery

    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

    Procedure/Surgery

    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 groups

60 Participants
are divided into 2 treatment groups
Group A: Experimental: craniosacral therapy techniques.Experimental treatment 1 intervention
Group B: Control: placebo comparator.Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
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).
2

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.

Time frame
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

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

Time frame
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).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

JJ JIMENEZ-REJANO

Lead sponsor

University of Seville

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: