AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

Safety and Feasibility of TWIICE Rise - Phase 2

RecruitingNAAges 18 Years - 70 YearsAllTWIICE
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

The aim of this study is to assess the safety and the feasibility of two versions of TWIICE Rise for exoskeleton-assisted ambulation in patients with a spinal cord injury. This study is done in two phases: The first phase evaluates the safety and feasibility of TWIICE Rise 0.0 with 5 patients over 6 sessions in clinic. The second phase is being conducted with TWIICE Rise 1.0. This version has potentially improved functionalities based on feedback from Phase 1. Safety and feasibility will be assessed with 10 patients over 10 sessions in different settings (clinic, home, and community environment).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Informed Consent signed by the subject. 2. Traumatic and non-traumatic SCI 3. Motor incomplete SCI with Neurological Level of Injury (NLI) C5-L5, or Motor Complete SCI with NLI T1-L5 as determined by the ISNCSCI. 4. Male and non-pregnant, non-lactating female aged 18 to 70 years old 5. At least 6 months after injury 6. Able to stand or maintain upright position with a standing device (e.g., 'Easy stand') for at least ten minutes without clinical symptoms of orthostatic hypotension. 7. Able to use crutches. 8. Able to sit with knees and hips \>= 90ยฐ flexion 9. Phase 1: Height of 160 to 180 cm, Phase 2: Height of 160 to 190 cm 10. Phase 1: Weight of \<80 kg, Phase 2: Weight of \<100 kg Exclusion Criteria: 1. History of severe neurological injuries other than spinal cord injury (e.g., Multiple Sclerosis, Cerebral Palsy, Amyotrophic Lateral Sclerosis, Traumatic Brain Injury, Stroke) 2. Ability to walk 10 meters without physical assistance of a person 3. Severe concurrent medical disease, illness, or condition 4. Systemic or peripheral infection influencing wearing an exoskeleton. 5. Diagnosis of coronary artery disease that precludes moderate to intense exercise. 6. A medical diagnosis in the patient chart of atherosclerosis, congestive heart failure, or history of myocardial infarction 7. Individuals with a pacemaker, defibrillator, drug delivery pump, or other electrical devices if malfunctions could lead to serious adverse events. 8. Deep vein thromboses in lower extremities of less than 6 months duration. 9. Untreated sever hypertension (systolic blood pressure \>180 mmHg, diastolic blood pressure \>120 mmHg) 10. Unstable spine or unhealed limbs 11. History of lower extremities or pelvic fragility fractures within the last two years 12. Heterotopic ossification that impairs joint mobility 13. Significant contractures defined as flexion contracture limited to 20 the hip and knee. 14. Severe spasticity (Modified Ashworth grade 4) or uncontrolled clonus 15. Diagnosis of severe osteoporosis/penia: Dual Energy X-ray Absorptiometry (DXA) results indicating a t-score below -3.5 at the femoral neck or the total proximal femur bone, and knee bone mineral density (BMD) \< 0.60 gm/cm2 16. Current pressure ulcer of the arms, trunk, pelvic area, or lower extremities 17. Psychiatric or cognitive conditions that may interfere with the trial. 18. Pregnancy or women who plan to become pregnant during the study period, and lactating women. 19. Patient is currently involved in any other interventional study. 20. Other severe illness that the study physician considers in his/her clinical judgment to be exclusionary.
๐Ÿ’Š

What it tests

  • TWIICE Rise
๐Ÿ“

Where

1 site
Swiss Paraplegic Centre Nottwil
Nottwil, Switzerland
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy