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Clinical Trials in Switzerland / NCT07461259
Recruiting Not applicable

Safety and Feasibility of TWIICE Rise - Phase 2

NCT07461259 · tracked via the Priya Life Science Switzerland tracker
Sponsor
TWIICE
Phase
Not applicable
Started
2023-07-25
Last updated
2026-03-10

Condition(s) studied

Spinal Cord InjuriesGait Disorders, Neurologic

Investigational drug(s) / intervention(s)

TWIICE Rise

TWIICE Rise: TWIICE Rise is a lower-limb overground robotic exoskeleton intended for patients with spinal cord injury (SCI). TWIICE Rise is intended to perform ambulatory functions in rehabilitation institutions, home, or community environment under the supervision of a specially trained coach.

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Swiss Paraplegic Centre Nottwil Nottwil Canton of Lucerne Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07461259 on ClinicalTrials.gov ↗ ← All trials in Switzerland