Actively Recruiting
Safety and Feasibility of TWIICE Rise - Phase 2
Led by TWIICE · Updated on 2026-03-10
15
Participants Needed
1
Research Sites
209 weeks
Total Duration
On this page
Sponsors
T
TWIICE
Lead Sponsor
S
Swiss Paraplegic Research, Nottwil
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Safety and Feasibility of TWIICE Rise - Phase 2
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Traumatic or non-traumatic spinal cord injury
- Motor incomplete spinal cord injury with neurological level C5-L5, or motor complete spinal cord injury with neurological level T1-L5
- Male or non-pregnant, non-lactating female aged 18 to 70 years
- At least 6 months post-injury
- Able to stand or maintain upright with a standing device for at least ten minutes without orthostatic hypotension symptoms
- Able to use crutches
- Able to sit with knees and hips at least 90 degrees flexion
- Height between 160 and 180 cm for phase 1, 160 to 190 cm for phase 2
- Weight less than 80 kg for phase 1, less than 100 kg for phase 2
You will not qualify if you...
- History of severe neurological injuries other than spinal cord injury (e.g., multiple sclerosis, cerebral palsy, amyotrophic lateral sclerosis, traumatic brain injury, stroke)
- Ability to walk 10 meters without physical assistance
- Severe concurrent medical disease or condition
- Systemic or peripheral infection affecting exoskeleton use
- Coronary artery disease preventing moderate to intense exercise
- Medical diagnosis of atherosclerosis, congestive heart failure, or history of myocardial infarction
- Presence of pacemaker, defibrillator, drug pump, or other electrical devices with risk of serious malfunction
- Deep vein thrombosis in lower limbs within last 6 months
- Untreated severe hypertension (systolic >180 mmHg, diastolic >120 mmHg)
- Unstable spine or unhealed limbs
- History of lower extremity or pelvic fractures within last two years
- Heterotopic ossification impairing joint mobility
- Significant contractures limiting hip and knee flexion to 20 degrees
- Severe spasticity (Modified Ashworth grade 4) or uncontrolled clonus
- Severe osteoporosis (DXA t-score below -3.5) or low knee bone mineral density (<0.60 gm/cm2)
- Current pressure ulcers on arms, trunk, pelvis, or lower limbs
- Psychiatric or cognitive conditions interfering with participation
- Pregnancy, planning pregnancy, or lactating
- Participation in other interventional studies
- Other severe illnesses deemed exclusionary by study physician
AI-Screening
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Trial Site Locations
Total: 1 location
1
Swiss Paraplegic Centre Nottwil
Nottwil, Canton of Lucerne, Switzerland, 6207
Actively Recruiting
Research Team
M
Mario Widmer, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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