TWIICE Rise exoskeleton for assisted walking after spinal cord injury
Two-phase Pilot Study on the Safety and Feasibility of TWIICE Rise for Exoskeleton-assisted Ambulation in Patients With Spinal Cord Injury
This will test two versions of the TWIICE Rise wearable exoskeleton in adults with spinal cord injury to see if they can safely practice walking in clinic, at home, and in the community.
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, Canton of Lucerne) |
| Trial ID | NCT07461259 on ClinicalTrials.gov |
What this trial studies
The trial examines safety and feasibility of two iterations of the TWIICE Rise lower-limb exoskeleton in people with spinal cord injury. Phase 1 enrolls five participants who complete six supervised clinic sessions with TWIICE Rise 0.0 to gather safety and usability data for device refinement. Phase 2 enrolls ten participants who complete ten sessions with TWIICE Rise 1.0 across clinic, home, and community settings after initial training at a specialized rehabilitation center and meeting predefined Mobility Skills Test milestones. Primary outcomes include device-related adverse events, ability to perform mobility tasks with the exoskeleton, and practical feasibility in real-world settings.
Who should consider this trial
Good fit: Adults 18–70 with traumatic or non-traumatic spinal cord injury at least six months post-injury who meet ISNCSCI motor-level criteria (motor-incomplete C5–L5 or motor-complete T1–L5), can use crutches and stand for 10 minutes with a standing device, and fit the study height and weight limits (Phase 1: 160–180 cm and <80 kg; Phase 2: 160–190 cm and <100 kg).
Not a fit: Individuals who can walk 10 meters without physical assistance, have other severe neurological diseases or major medical contraindications, are pregnant or lactating, or fall outside the device's height/weight limits are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the device could enable safer, more frequent upright mobility and walking practice for people with spinal cord injury, potentially improving independence and quality of life.
How similar studies have performed: Previous trials of other powered exoskeletons (for example ReWalk and Ekso) have demonstrated feasibility and acceptable safety in small cohorts, though results vary by device and long-term functional benefit remains limited.
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, Canton of Lucerne
- Swiss Paraplegic Centre Nottwil — Nottwil, Canton of Lucerne, 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.