G93.3
Conditions
Interventions
Group 1: The total study duration is 28 weeks, plus one initial week for baseline assessment.
Participants in Group A start immediately with the Galileo® vibration training, followed by a control phas
Sponsors
Uniklinik Köln
Eligibility
Sex/Gender
All
Age
6 Years to 21 Years
Inclusion criteria
Inclusion criteria: Confirmed diagnosis of Myalgic Encephalomyelitis / Chronic Fatigue Syndrome (ME/CFS) Age between 6 and 21 years (inclusive) Bell’s Score > 35, indicating sufficient baseline activity Written informed consent obtained from the legal guardian and, when applicable, from the participant Cognitive ability to follow study instructions and training procedures
Exclusion criteria
Exclusion criteria: No confirmed diagnosis of ME/CFS Therapy-refractory epilepsy Severe congenital malformations (e.g. complex congenital heart defect) Pacemaker or cochlear implant Thrombosis or endoprosthesis Recent disc prolapse Surgically relevant hernia Botulinum toxin therapy Fracture, intracerebral hemorrhage, or surgery within the last 3 months Planned surgery during the study period Participation in another interventional study Gallstones or kidney stones in the participant or the assisting person Pregnancy of the participant or the assisting person Lack of written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is the evaluation of the effect of side-alternating whole-body vibration training (Galileo) on the motor development of children, adolescents, and young adults with Myalgic Encephalomyelitis / Chronic Fatigue Syndrome (ME/CFS). Motor development is quantitatively assessed using the Gross Motor Function Measure-66 (GMFM-66). | — |
Secondary
| Measure | Time frame |
|---|---|
| Feasibility of side-alternating whole-body vibration training (Galileo®) ? assessing adherence, training frequency, and feasibility in everyday life. Safety of the intervention ? monitoring for adverse events during and after the training periods. Bell’s Score: Measures disease severity and daily functional capacity in ME/CFS. Health-related quality of life (PedsQL™): Assessed using the Generic Core Scale and the Multidimensional Fatigue Scale. German Motor Test 6–18 (DMT 6–18): Evaluates gross motor skills and physical performance. Physical activity: Objectively tracked via fitness tracker (steps, walking distance, sleep quality). Jump mechanography: Assesses muscular strength and neuromuscular efficiency (Nerve-Muscle Index, NMI). DISYPS-II: Diagnostic System for Mental Disorders (ICD-10/DSM-IV) to identify psychological symptoms and exclude depressive disorders. | — |
Countries
Germany
Contacts
Public ContactHormos Salimi Dafsari
Uniklinik Köln
Outcome results
None listed