NCT Number: NCT07029425
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.
Trial opening soon.
Get Notified6 year–12 year
All sexes
Interventional
Not applicable
Alcalá de Henares, Madrid, 28804, Spain
Jose-Jesus Jimenez-Rejano, PhD
SUB_INVESTIGATOR
Paloma Felipe-Ballesteros, PT
CONTACT
Paloma Felipe-Ballesteros, PT
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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).
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).
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).
Facial Expression Scale. It represents expressions from sadness (scored with 1) to happiness (scored with 4).
Contact information is provided by the study sponsor or research team.
Paloma Felipe-Ballesteros, PT
CONTACT
Paloma Felipe-Ballesteros, PT
CONTACT
JJ JIMENEZ-REJANO
Other
Acronym: MT-ADHD
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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