Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-24 @ 6:38 PM
NCT ID:
NCT02443857
Eligibility Criteria:
Inclusion Criteria:
* Age between 5 and 21 years
* Neurological diagnoses
* Impairment of the upper extremity (for projects (i) and (ii) we might also include patients without upper extremity impairments to cover a wide range of patients with different abilities)
* Other (non-neurological) diagnoses, who require intense training of the upper extremity
Exclusion Criteria:
* Strong adipositas, which makes it not possible to adjust the cuffs and orthoses to the anthropometrics of the participant
* Fixed contractures of the upper extremity that should be positioned in ChARMin
* Instabilities of bones or joints, fractures or osteoporosis/osteopenia
* Allergy against material of cuffs
* Open skin lesions of the upper extremity that should be positioned in ChARMin
* Luxations or subluxations of joints of the upper extremity that should be positioned in ChARMin
* Strong pain that increases while training in ChARMin\*
* Injuries or lesioned nerves of the upper extremity that should be positioned in ChARMin\*
* Strong spontaneous movements like ataxia, dyskinesia, myoclonus\*
* Instable vital functions like pulmonal or cardiovascular conditions
* Implanted pace maker, defibrillator of the heart
* Implanted shunt by hydrocephalus\*
* Implanted cochlear or baha\*
* Uncooperative or aggressive behaviour
* Known or suspected non-compliance
* Severe cognitive deficits
* Inability to signal pain or discomfort
* Apraxia\*
* Severe visual impairment (inability to see the screen)
* Severe spasticity (Ashworth 4)
* Severe epilepsy\*
* Insufficient head stability
* Infections requiring isolation of the patient Contraindications marked with an \* are relative contraindications. Final approval needs to be obtained from the medical doctor.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
21 Years
Study:
NCT02443857
Study Brief:
Protocol Section:
NCT02443857