Status:
COMPLETED
LEAP a New Overground Body Weight Support Robot: Usability Trial
Lead Sponsor:
Clinique Romande de Readaptation
Conditions:
Spinal Cord Injuries
Cerebral Palsy
Eligibility:
All Genders
5-80 years
Phase:
NA
Brief Summary
People with central nervous system disorders such as spinal cord injury, stroke, cerebral palsy, Parkinson's disease, multiple sclerosis, etc… often have impaired lower extremity function that limits ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2018
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT03458169
Start Date
January 1 2018
End Date
April 30 2018
Last Update
January 30 2019
Active Locations (1)
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1
Clinique Romande de Réadaptation (CRR), SUVAcare
Sion, Valais, Switzerland, 1951