Spinal Cord InjuriesNCT07461259
Safety and Feasibility of TWIICE Rise - Phase 2
A study testing TWIICE Rise in people with Spinal Cord Injuries and Gait Disorders, Neurologic, run by TWIICE at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Cord Injuries, Gait Disorders, Neurologic
- What is being tested?
- TWIICE Rise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSwitzerland
- Study dates
- 25 Jul 2023to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed Consent signed by the subject.
- Traumatic and non-traumatic SCI
- Motor incomplete SCI with Neurological Level of Injury (NLI) C5-L5, or Motor Complete SCI with NLI T1-L5 as determined by the ISNCSCI.
- Male and non-pregnant, non-lactating female aged 18 to 70 years old
- At least 6 months after injury
- 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.
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- Able to use crutches.
- Able to sit with knees and hips >= 90° flexion
- Phase 1: Height of 160 to 180 cm, Phase 2: Height of 160 to 190 cm
- Phase 1: Weight of <80 kg, Phase 2: Weight of <100 kg
Who cannot join
- 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 of a person
- Severe concurrent medical disease, illness, or condition
- Systemic or peripheral infection influencing wearing an exoskeleton.
- Diagnosis of coronary artery disease that precludes moderate to intense exercise.
- A medical diagnosis in the patient chart of atherosclerosis, congestive heart failure, or history of myocardial infarction
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- Individuals with a pacemaker, defibrillator, drug delivery pump, or other electrical devices if malfunctions could lead to serious adverse events.
- Deep vein thromboses in lower extremities of less than 6 months duration.
- Untreated sever hypertension (systolic blood pressure >180 mmHg, diastolic blood pressure >120 mmHg)
- Unstable spine or unhealed limbs
- History of lower extremities or pelvic fragility fractures within the last two years
- Heterotopic ossification that impairs joint mobility
- Significant contractures defined as flexion contracture limited to 20 the hip and knee.
- Severe spasticity (Modified Ashworth grade 4) or uncontrolled clonus
- 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
- Current pressure ulcer of the arms, trunk, pelvic area, or lower extremities
- Psychiatric or cognitive conditions that may interfere with the trial.
- Pregnancy or women who plan to become pregnant during the study period, and lactating women.
- Patient is currently involved in any other interventional study.
- Other severe illness that the study physician considers in his/her clinical judgment to be exclusionary.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Swiss Paraplegic Centre Nottwil
Nottwil, Canton of Lucerne, 6207
Mario Widmer, PhD, +41 41 939 51 97, mario.widmer@paraplegie.ch
About this study
Official title: Two-phase Pilot Study on the Safety and Feasibility of TWIICE Rise for Exoskeleton-assisted Ambulation in Patients With Spinal Cord Injury
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).
Read the detailed description
The aim of this clinical trial 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. The study is thus done in two phases.
The first phase evaluates the safety and feasibility of TWIICE Rise 0.0 with five patients over 6 sessions in clinic. This phase allows the manufacturer to collect data that can be used to improve the device design if necessary.
The second phase of the study is being conducted with TWIICE Rise 1.0. Safety and feasibility will be assessed with 10 patients over 10 sessions in different settings (clinic, home, and community environment) to test the device intended use. The first sessions are done at the rehabilitation specialized center to benefit from the clinical settings to learn to walk with the exoskeleton. Once the patients reach sufficient ambulatory skills determined by the Mobility SkillsTests, the following sessions can be done at home and community settings.
- Conditions
- Spinal Cord Injuries, Gait Disorders, Neurologic
- Being tested
- TWIICE Rise
- Keywords
- Spinal Cord Injury, Exoskeleton, Robotics, Gait Rehabilitation, Lower-limb, Neurorehabilitation, Paraplegia, Walking, Assistive technology, Usability, Feasibility, Home use, Community use
- Medical subject headings
- Spinal Cord Injuries, Gait Disorders, Neurologic, Paraplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TWIICE RiseDevice
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 group | Role | What they receive |
|---|---|---|
| Exoskeleton assisted ambulation | Experimental | Phase 1: Five participants will undergo a training programme with the TWIICE Rise 0.0 two times a week for up to 6 weeks for a total of 6 sessions.
Phase 2: Ten participants will undergo a training programme with the TWIICE Rise 1.0 2-3 times a week for up to 10 weeks for a total of 10 sessions. Receives: Device: TWIICE Rise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of (serious) adverse device effects [Safety]
This outcome is commonly used in healthcare for the measurement of patient safety.
Measured: From enrollment to the end of intervention at 10 weeks
Incidence of device deficiencies [Safety]
Device deficiencies will be assessed according to ISO 14155 (any inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety, or performance). All device deficiencies will be prospectively recorded by study personnel in the Case Report Form at each device-use session and via interim reports throughout the 10-week intervention. Incidence is defined as the number of new device deficiencies occurring during the study period per participant and per device-use session
Measured: From enrollment to the end of intervention at 10 weeks
Secondary outcomes (17)
Incidence of (serious) adverse events [Safety]
This outcome is commonly used in healthcare for the measurement of patient safety.
Measured: From enrollment to the end of intervention at 10 weeks
Heart rate (pre-training, when standing, and post-training) [Safety]
Heart rate (beats per minute) will be measured using a wearable heart-rate monitor
Measured: First four session of each participant at three standardized time points: (1) 1 minute before standing, (2) after 1 minute of supported standing in the device (3) within 1 minute after completion of the training session (post-training)
Systolic and diastolic blood pressure (pre-training, when standing, and post-training) [Safety]
Systolic and diastolic blood pressure (mmHg) will be measured using an automated upper-arm blood pressure monitor
Measured: First four session of each participant at three standardized time points: (1) 1 minute before standing, (2) after 1 minute of supported standing in the device (3) within 1 minute after completion of the training session (post-training)
Pain rating and location [Safety]
Used to assess whether training with TWIICE Rise does not cause or exacerbate pain.
Pain intensity and location are assessed at the beginning of each session. Pain intensity is evaluated using the Pain Numeric Rating Scale that is a unidimensional measure of pain in adult. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Measured: From enrollment to the end of intervention at 10 weeks
Fatigue rating [Safety]
Used as a measure of exertion due to training with TWIICE Rise. Fatigue is assessed pre-training and post training. The Fatigue Numeric Rating Scale is a patient-administered, single-item, 11-point horizontal scale anchored at 0 and 10, with 0 representing 'no fatigue' and 10 representing 'as bad as you can imagine'.
Measured: From enrollment to the end of intervention at 10 weeks
Skin status rating [Safety]
Used to assess whether the device's interfaces cause skin lesions. Skin status is rated on a 0 to 4 pressure ulcer scale, 0 representing 'no skin injury' and '4' representing 'very deep wound'.
Measured: From enrollment to the end of intervention at 10 weeks
Number of steps recorded by exoskeleton per training session [Feasibility]
Step count (number of steps) will be automatically recorded by the TWIICE Rise exoskeleton system log during each training session. Steps per session will be summarized across sessions to characterize feasibility and extent of device-assisted walking activity during training.
Measured: Each training session from first session through end of intervention (10 weeks)
Training location [Feasibility, phase 2 only]
Used to evaluate the feasibility of using the device in different environments such clinics, home and community settings and the number of sessions in each condition
Measured: From enrollment to the end of intervention at 10 weeks
Type of suface walked on [Feasibility]
This indicated the feasibility of walking on different type of terrain.
Measured: From enrollment to the end of intervention at 10 weeks
6-Meter Walk Test (6MWT) + Level of Assistance [Feasibility]
The distance walked with the powered exoskeleton during the 6MWT. The 6MWT is the primary assessment used to determine the progression of walking skills in exoskeletons.
Measured: From enrollment to the end of intervention at 10 weeks
10-Meter Walk Test (10MWT) + Level of Assistance [Feasibility]
The 10MWT is the best effort time (seconds) it takes the participant to walk a 10 m distance and is recorded while the person performs the 6MWT. This allows assessing the walking speed.
Measured: From enrollment to the end of intervention at 10 weeks
Time Up and Go (TUG) + Level of Assistance [Feasibility]
The TUG test measures the time it takes the participant to stand up from a seated position, walk three meters, turn around, walk back, and sit down again. The TUG test represents the person s ability to use the exoskeletal system since it incorporates multiple aspects of mobility in the device.
Measured: From enrollment to the end of intervention at 10 weeks
Donning and doffing time + Level of Assistance [Feasibility]
Used to evaluate the time needed to install the user inside the device (donning) and back to the wheelchair (doffing). It assesses the feasibility and usability of a device, as the setup time is usually a determining factor for assisting devices.
Measured: From enrollment to the end of intervention at 10 weeks
Mobility skills test + Level of Assistance [Feasibility]
Used to assess the feasibility of the mobility tasks intended with TWIICE Rise. Mobility skills such as standing, walking on different type of ground, and step on a stair are measured separately of each other in an ascending order of difficulty, until two skills cannot be achieved without moderate or maximal assistance.
Measured: up to 16 weeks
Slope inclination
Used to mesure the slope inclination on which the participants walked
Measured: From enrollment to the end of intervention at 10 weeks
Walking speed recorded by exoskeleton during training sessions [Feasibility]
Walking speed (meters/second) will be automatically recorded by the TWIICE Rise exoskeleton system log during each training session. Mean and peak walking speed per session will be summarized across sessions to characterize feasibility and locomotor performance during device-assisted training.
Measured: Each training session from first session through end of intervention (10 weeks)
Time spent in exoskeleton activity modes per training session [Feasibility]
Time (minutes) spent in each exoskeleton operating mode (e.g., sitting, standing, walking) will be automatically recorded by the TWIICE Rise exoskeleton system log during each training session. Duration in each mode and total active training time per session will be summarized across sessions to characterize feasibility and patterns of device use during training.
Measured: Each training session from first session through end of intervention (10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start25 Jul 2023
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TWIICE
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Swiss Paraplegic Research, Nottwil
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07461259
- Sponsor's protocol ID
- TWIICE-2021-15-P2
- Status last verified
- Mar 2026
- First submitted
- 22 Apr 2024
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two-phase Pilot Study on the Safety and Feasibility of TWIICE Rise for Exoskeleton-assisted Ambulation in Patients With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT07461259
- Acronym / sponsor ID
- TWIICE-2021-15-P2
- Conditions
- Spinal Cord Injuries, Gait Disorders, Neurologic
- Keywords
- Spinal Cord Injury, Exoskeleton, Robotics, Gait Rehabilitation, Lower-limb, Neurorehabilitation, Paraplegia, Walking
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- TWIICEIndustry (pharma, biotech, devices)
- Collaborators
- Swiss Paraplegic Research, Nottwil
- Study start
- 25 Jul 2023 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The aim of this clinical trial 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. The study is thus done in two phases.
The first phase evaluates the safety and feasibility of TWIICE Rise 0.0 with five patients over 6 sessions in clinic. This phase allows the manufacturer to collect data that can be used to improve the device design if necessary.
The second phase of the study is being conducted with TWIICE Rise 1.0. Safety and feasibility will be assessed with 10 patients over 10 sessions in different settings (clinic, home, and community environment) to test the device intended use. The first sessions are done at the rehabilitation specialized center to benefit from the clinical settings to learn to walk with the exoskeleton. Once the patients reach sufficient ambulatory skills determined by the Mobility SkillsTests, the following sessions can be done at home and community settings.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exoskeleton assisted ambulation | Experimental | Device: TWIICE RisePhase 1: Five participants will undergo a training programme with the TWIICE Rise 0.0 two times a week for up to 6 weeks for a total of 6 sessions. Phase 2: Ten participants will undergo a training programme with the TWIICE Rise 1.0 2-3 times a week for up to 10 weeks for a total of 10 sessions. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Informed Consent signed by the subject.
- Traumatic and non-traumatic SCI
- Motor incomplete SCI with Neurological Level of Injury (NLI) C5-L5, or Motor Complete SCI with NLI T1-L5 as determined by the ISNCSCI.
- Male and non-pregnant, non-lactating female aged 18 to 70 years old
- At least 6 months after injury
Key exclusion criteria (20 listed)
- 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 of a person
- Severe concurrent medical disease, illness, or condition
- Systemic or peripheral infection influencing wearing an exoskeleton.
- Diagnosis of coronary artery disease that precludes moderate to intense exercise.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TWIICE RiseTWIICE 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. | Device | Exoskeleton assisted ambulation |
Primary outcome
Incidence of (serious) adverse device effects [Safety]
Time frame: From enrollment to the end of intervention at 10 weeks
This outcome is commonly used in healthcare for the measurement of patient safety.
Incidence of device deficiencies [Safety]
Time frame: From enrollment to the end of intervention at 10 weeks
Device deficiencies will be assessed according to ISO 14155 (any inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety, or performance). All device deficiencies will be prospectively recorded by study personnel in the Case Report Form at each device-use session and via interim reports throughout the 10-week intervention. Incidence is defined as the number of new device deficiencies occurring during the study period per participant and per device-use session
17 secondary outcomes
Incidence of (serious) adverse events [Safety]
Time frame: From enrollment to the end of intervention at 10 weeks
Heart rate (pre-training, when standing, and post-training) [Safety]
Time frame: First four session of each participant at three standardized time points: (1) 1 minute before standing, (2) after 1 minute of supported standing in the device (3) within 1 minute after completion of the training session (post-training)
Systolic and diastolic blood pressure (pre-training, when standing, and post-training) [Safety]
Time frame: First four session of each participant at three standardized time points: (1) 1 minute before standing, (2) after 1 minute of supported standing in the device (3) within 1 minute after completion of the training session (post-training)
Pain rating and location [Safety]
Time frame: From enrollment to the end of intervention at 10 weeks
Fatigue rating [Safety]
Time frame: From enrollment to the end of intervention at 10 weeks
Skin status rating [Safety]
Time frame: From enrollment to the end of intervention at 10 weeks
Number of steps recorded by exoskeleton per training session [Feasibility]
Time frame: Each training session from first session through end of intervention (10 weeks)
Training location [Feasibility, phase 2 only]
Time frame: From enrollment to the end of intervention at 10 weeks
Type of suface walked on [Feasibility]
Time frame: From enrollment to the end of intervention at 10 weeks
6-Meter Walk Test (6MWT) + Level of Assistance [Feasibility]
Time frame: From enrollment to the end of intervention at 10 weeks
10-Meter Walk Test (10MWT) + Level of Assistance [Feasibility]
Time frame: From enrollment to the end of intervention at 10 weeks
Time Up and Go (TUG) + Level of Assistance [Feasibility]
Time frame: From enrollment to the end of intervention at 10 weeks
Donning and doffing time + Level of Assistance [Feasibility]
Time frame: From enrollment to the end of intervention at 10 weeks
Mobility skills test + Level of Assistance [Feasibility]
Time frame: up to 16 weeks
Slope inclination
Time frame: From enrollment to the end of intervention at 10 weeks
Walking speed recorded by exoskeleton during training sessions [Feasibility]
Time frame: Each training session from first session through end of intervention (10 weeks)
Time spent in exoskeleton activity modes per training session [Feasibility]
Time frame: Each training session from first session through end of intervention (10 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TWIICE Rise in people with Spinal Cord Injuries and Gait Disorders, Neurologic, run by TWIICE at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mario Widmer, PhD (+41 41 939 51 97, mario.widmer@paraplegie.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of (serious) adverse device effects [Safety] (time frame: From enrollment to the end of intervention at 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.