Safety and Feasibility of TWIICE Rise - Phase 2

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).

Study Overview

• Status: Recruiting
• Conditions: Spinal Cord Injuries; Gait Disorders, Neurologic
• Intervention / Treatment: Device: TWIICE Rise

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 Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mario Widmer, PhD; Phone Number: +41 41 939 51 97; Email: mario.widmer@paraplegie.ch

Study Locations

• Switzerland
  • Canton of Lucerne
    • Nottwil, Canton of Lucerne, Switzerland, 6207
      • Recruiting
      • Swiss Paraplegic Centre Nottwil
      • Contact: Mario Widmer, PhD; Phone Number: +41 41 939 51 97; Email: mario.widmer@paraplegie.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exoskeleton assisted ambulation; 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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of (serious) adverse device effects [Safety]	This outcome is commonly used in healthcare for the measurement of patient safety.	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	From enrollment to the end of intervention at 10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of (serious) adverse events [Safety]	This outcome is commonly used in healthcare for the measurement of patient safety.	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	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	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").	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'.	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'.	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.	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	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.	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.	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.	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.	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.	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.	up to 16 weeks
Slope inclination	Used to mesure the slope inclination on which the participants walked	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.	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.	Each training session from first session through end of intervention (10 weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quebec User Evaluation of Satisfaction with assistive Technology (QUEST 2.0) [Satisfaction]	Used to measure user satisfaction from participants and therapists. The Quebec User Evaluation of Satisfaction with assistive Technology (QUEST 2.0) is designed to measure the level of satisfaction and the value people attribute to assistive technologies. It does so using 12 variables which are scored on a 5 point scale in terms of perceived importance and satisfaction. While items 1-8 rate the satisfaction with the device, items 9-12 are for assessing the satisfaction with the service. If the users are not very satisfied with a feature, they are asked to provide specific feedback. The final score is the mean sum scores of all valid responses with a range of 1 (not satisfied at all) to 5 (very satisfied).	up to 16 weeks
Open-ended questionnaire [Satisfaction]	Used to study design modifications requested by users and clinicians.	up to 16 weeks
Subjective health-related questionnaire [General Health]	4-item questionnaire to assess potential health-related changes due to regular exoskeleton-assisted ambulation, with a 5-point Likert-scale (1 = 'strongly disagree' and 5 = 'strongly agree').	From enrollment to the end of intervention at 10 weeks
Psychosocial Impact of Assistive Devices Scales [General Health]	The Psychosocial Impact of Assistive Devices Scales (PIADS) is a 26-item (7-point Likert-Scale), self-report questionnaire designed to assess the effects of an assistive device on functional independence, well-being, and quality of life. It is divided into three subscales: Competence, adaptability and self-esteem. For each of the subscales, typically means are calculated that range from -3 (maximum negative impact) to +3 (maximum positive impact). To have only positive sum scores, the range of the individual scores are shifted to 1 to 7, meaning that sum scores range from 1 *26 (26, maximum negative impact) to 7 *26 (182, maximum positive impact). The PIADS is a responsive measure and sensitive to important variables such as the user's clinical condition, device stigma, and functional features of the device. It has been shown to accurately reflect the self-described experiences of people who use assistive devices.	From enrollment to the end of intervention at 10 weeks

Collaborators and Investigators

• Sponsor: TWIICE
• Collaborators: Swiss Paraplegic Research, Nottwil

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2023
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: April 22, 2024
• First Submitted That Met QC Criteria: March 4, 2026
• First Posted (Actual): March 10, 2026

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Feasibility; Assistive technology; Robotics; Walking; Spinal Cord Injury; Exoskeleton; Usability; Neurorehabilitation; Paraplegia; Gait Rehabilitation; Lower-limb; Home use; Community use
• Additional Relevant MeSH Terms: Neurologic Manifestations; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Paralysis; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Spinal Cord Injuries; Gait Disorders, Neurologic; Paraplegia
• Other Study ID Numbers: TWIICE-2021-15-P2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No