Safety and Feasibility of TWIICE Rise - Phase 2
Recruiting
N/A
Interventional Study
Spinal Cord Injuries
Gait Disorders, Neurologic
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 70
- Sex
- Any
- Study type
- Interventional
- Purpose
- Other
- Participants needed
- 15 (estimated)
- Sponsor
- TWIICE · Industry
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About This Trial
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 po…
Trial Locations
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Eligibility 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 ye…
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