The osteopathic treatment of children and adolescents diagnosed with attention deficit hyperactivity disorder with and without hyperactivity (ADHD/ADS)

Phase 2

Lead Sponsor: Osteopathie Schule DeutschlandDresden International University / TU-Dresden

Recruitment & Eligibility

Inclusion Criteria

Children and young people between the ages of 11 and 17 inclusive of any gender

- medically diagnosed ADD/ADHD according to ICD-10 F90.-

- can understand, read and write the German language

Exclusion Criteria

- acute infectious diseases

- neurological disease like epilepsy

- major changes in other therapies during the study phase study phase must be documented

- Illnesses that prevent the child from participating in everyday participate in everyday school life for more than three days

- children with heart disease and/or asthma

- Children with physical, mental, sensory and speech disabilities

Primary Outcome Measures

Name	Time	Method
As a primary outcome parameter, the feasibility/feasibility of a further study will be investigated. For this purpose, the patient recruitment rate, the retention rate and the safety of the interventions will be investigated.<br><br>Recruitment rate: If one subject recruits to the study every two days in a two months, the recruitment rate will is 100%. The study is judged feasible at a recruitment rate of minimum of 80%. <br><br>Retention rate: The retention rate of the subjects must not be less than 90% of the study participants. If the retention rate is above 90%, the study will be judged is considered feasible.<br><br>Safety of the intervention: Subjects must not have any side effects in three different body systems lasting more than 24 hours. If this is met, the intervention is rated as safe and the study is rated as feasible.

Secondary Outcome Measures

Name	Time	Method
As a secondary outcome parameter, the treatment effect will be examined using the three leading symptoms of inattention, hyperactivity, and impulsivity. These are described in the two classifications ICD-10 and DSM-IV and are measured and are assessed with the help of the Conners Scale and the SDQ questionnaire. Furthermore, the heart rate variability of the children will be assessed using the Cardio-Secur Plus. Subsequently, the collected data will be stored pseudo-anonymously, statistically analyzed and discussed in writing. This will measure the reduction of ADHD symptoms using the Conners scale and the SDQ questionnaire. The abstraction/increase of HF will be measured using HRV.