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 @ 10:58 PM
Ignite Modification Date:
2025-12-24 @ 10:58 PM
NCT ID:
NCT03458169
Eligibility Criteria:
Healthy participants fulfilling all of the following inclusion criteria are eligible for the study:
* The healthy volunteer or legal representative has been informed and has signed the informed consent form
* Age 18-80 or age 5-10 (women or men)
* Weight below 137 kg
* Height between 120 and 190 cm
* Agree to comply in good faith with all conditions of the study and to attend all required training
Patients fulfilling all of the following inclusion criteria are eligible for the study:
* The patient has been informed and has signed the informed consent form
* Age 18-80 (women or men)
* Weight below 137 kg
* Height between 120 and 190 cm
* Neurological/musculoskeletal diagnoses
* Impairment of the lower extremities
* Stable medical and physical condition as considered by the attending doctor or physician
* Agree to comply in good faith with all conditions of the study and to attend all required training
* Other (non-neurological) diagnoses, who require intense training of the lower extremities
* The rehabilitation physician or doctor provides a final agreement whether the participant can train with the LEAP
The presence of any one of the following exclusion criteria will lead to exclusion of the participant, for example:
* Strong adipositas, which makes it not possible to adjust the harness to the anthropometrics of the participant
* Bracing of the spinal column.
* Severe joint contractures disabling or restricting lower limb movements
* Instabilities of bones or joints, fractures or osteoporosis/osteopenia
* Allergy against material of harness
* Open skin lesions
* Luxations or subluxations of joints that should be positioned in LEAP
* Strong pain
* Strong spontaneous movements like ataxia, dyskinesia, myoclonus\*
* Instable vital functions like pulmonal or cardiovascular conditions
* Uncooperative or aggressive behaviour
* Severe cognitive deficits
* Inability to signal pain or discomfort
* Apraxia\*
* Severe spasticity (Ashworth 4)
* Severe epilepsy\*
* Insufficient head stability
* Infections requiring isolation of the patient
* History of significant autonomic dysreflexia
* Systemic malignant disorders
* Cardiovascular disorders restricting physical training
* Peripheral nerve disorders
* Other anatomic or co-morbid conditions that, in the investigator's opinion, could limit the patient's ability to participate in the study or to comply with follow-up requirements, or impact the scientific soundness of the study results.
* Known or suspected non-compliance, drug or alcohol abuse,
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
* Participation in another study with investigational drug within the 30 days preceding and during the present study
* Previous enrolment into the current study Contraindications marked with an \* are relative contraindications. Final approval needs to be obtained from the attending medical doctor.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
80 Years
Study:
NCT03458169
Study Brief:
Protocol Section:
NCT03458169