Assessing the safety and feasibility of TWIICE Rise for exoskeleton-assisted walking
Two-phase Pilot Study on the Safety and Feasibility of TWIICE Rise for Exoskeleton-assisted Ambulation in Patients With Spinal Cord Injury
This study is testing two versions of the TWIICE Rise exoskeleton to see if they can help people with spinal cord injuries walk safely and effectively in different settings.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Twiice Industry-sponsored |
| Locations | 1 site (Nottwil, LU) |
| Trial ID | NCT05926310 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and feasibility of two versions of the TWIICE Rise exoskeleton for assisting ambulation in patients with spinal cord injuries. The study is conducted in two phases: the first phase involves five patients using TWIICE Rise 0.0 over six sessions in a clinical setting, while the second phase tests TWIICE Rise 1.0 with ten patients over 24 sessions in various environments including clinic, home, and community. The goal is to gather data on the device's performance and improve its design based on patient feedback and outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 70 with motor incomplete or complete spinal cord injuries who can stand with assistance and have been at least six months post-injury.
Not a fit: Patients who are able to walk 10 meters without assistance or have severe neurological conditions other than spinal cord injury may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance mobility and independence for patients with spinal cord injuries through advanced exoskeleton technology.
How similar studies have performed: Other studies have shown promise with exoskeleton-assisted rehabilitation, indicating potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 \>= 90° 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.
Where this trial is running
Nottwil, LU
- Swiss Paraplegic Centre Nottwil — Nottwil, Lu, Switzerland (Recruiting)
Study contacts
- Study coordinator: Mario Widmer, PhD
- Email: mario.widmer@paraplegie.ch
- Phone: +41 41 939 51 97
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.