Trial reportJournal of neuroengineering and rehabilitation2025
Safety assessment and feasibility of the TWIICE powered exoskeleton for assisted ambulation in individuals with spinal cord injury.
Trial report in Journal of neuroengineering and rehabilitation, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05926310 (Two-phase Pilot Study on the Safety and Feasibility of TWIICE Rise for Exoskeleton-assisted Ambulation in Patients With Spinal Cord Injury), which is not on this map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Two-phase Pilot Study on the Safety and Feasibility of TWIICE Rise for Exoskeleton-assisted Ambulation in Patients With Spinal Cord Injury
Who cites it
2 citing papers in PubMed.
- Clinical management of complications after chronic spinal cord injury: a review of recent advances.Annals of medicine · 2026Review
- Innovative Assistive Technologies for Tetraplegia: A Narrative Review of Systematic and Emerging Evidence.Healthcare (Basel, Switzerland) · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundFollowing spinal cord injury (SCI), powered exoskeletons have been shown to enable assisted walking and may also positively impact secondary health conditions. The TWIICE exoskeleton is intended to enable individuals with SCI to train at home or in community during their activities of daily living under the supervision of a therapist. The aim of this pilot clinical trial was to assess the safety and feasibility of the TWIICE powered exoskeleton for assisted ambulation in a clinical setting.
methodsThis single-arm, open label feasibility study included 5 non-ambulatory individuals at least 6 months after onset of traumatic or non-traumatic SCI. Participants used the TWIICE exoskeleton during 6 sessions in the therapy premises of a Swiss SCI-specialized clinic undergoing a progressive mobility training. The incidence of adverse device effects (ADEs) was the primary outcome. In addition, standard walking tests such as 10 m Walk Test (10MWT), 6-minute Walk Test (6MWT), and Timed Up and Go (TUG) were performed using the device during the final session to evaluate usability after short-term training. Data are presented as median (range).
resultsWe recruited 5 non-ambulatory individuals with SCI (2 females / 3 males, 32 (21-45) years of age). Four participants were motor complete (T6-T11) and 1 was motor incomplete (C7). Of the 10 adverse events occurring over the course of the 30 cumulative sessions, 4 were categorized as ADEs: reddening of the skin at contact points with the device (2x), transient intensification of neuropathic pain, and transient increase of spasticity. All ADEs subsided after a short time and without any sequelae. After 6 sessions, participants walked the 10MWT in 33 (24-144) seconds and were able to achieve 98 (37-137) meters during a 6MWT while using the device. Finally, the TUG was performed with the device and moderate assistance in 103 (61-135) seconds.
conclusionsNo serious safety concerns were identified during this feasibility study in a clinical setting. After 6 sessions, our relatively young and fit study population showed a variable but generally good performance in clinical measures when compared to reports on commercialized powered exoskeletons.
trial registrationClinicalTrials.gov ID: NCT05926310.
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