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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Mood | Facial Expression Scale. It represents expressions from sadness (scored with 1) to happiness (scored with 4). | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paloma Felipe-Ballesteros, PT | Contact | +34 672783021 | paloma.felipe@edu.uah.es | |
| Paloma Felipe-Ballesteros, PT | Contact | +34672783021 | paloma.felipe@edu.uah.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grupo de Investigación Área de Fisioterapia CTS 305 - Universidad de Sevilla, Sevilla, Spain 41009 | Alcalá de Henares | Madrid | 28804 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30420347 | Background | Chan SKC, Zhang D, Bogels SM, Chan CS, Lai KYC, Lo HHM, Yip BHK, Lau ENS, Gao TT, Wong SYS. Effects of a mindfulness-based intervention (MYmind) for children with ADHD and their parents: protocol for a randomised controlled trial. BMJ Open. 2018 Nov 12;8(11):e022514. doi: 10.1136/bmjopen-2018-022514. | |
| 24778002 | Background |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| 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. |
|
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