Effectiveness of Manual Therapy in the Treatment of Attention Deficit Hyperactivity Disorder
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Symptoms of ADHD (Parents Rating Scale)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Control: 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.
干预措施: Placebo Group (Procedure)
Experimental: craniosacral therapy techniques.
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.
干预措施: Procedure: craniosacral therapy techniques. (Procedure)
结局指标
主要结局
Symptoms of ADHD (Parents Rating Scale)
时间窗: 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.
Symptoms of ADHD (Teacher Rating Scale)
时间窗: 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.
次要结局
- 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).)
研究者
JJ JIMENEZ-REJANO
Director
University of Seville