Safety and Feasibility of TWIICE Rise - Phase 2

NCT07461259 | Recruiting DMC

• 1 other identifier: TWIICE-2021-15-P2
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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 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

Spinal Cord Injuries; Gait Disorders, Neurologic

Keywords

Spinal Cord Injury; Exoskeleton; Robotics; Gait Rehabilitation; Lower-limb; Neurorehabilitation; Paraplegia; Walking; Assistive technology; Usability; Feasibility; Home use; Community use

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (17)

• Incidence of (serious) adverse events [Safety]

  From enrollment to the end of intervention at 10 weeks

• Heart rate (pre-training, when standing, and post-training) [Safety]

  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]

  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]

  From enrollment to the end of intervention at 10 weeks

• Fatigue rating [Safety]

  From enrollment to the end of intervention at 10 weeks

Other Outcomes (4)

• Quebec User Evaluation of Satisfaction with assistive Technology (QUEST 2.0) [Satisfaction]

  up to 16 weeks

• Open-ended questionnaire [Satisfaction]

  up to 16 weeks

• Subjective health-related questionnaire [General Health]

  From enrollment to the end of intervention at 10 weeks

Study Arms (1)

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.

Device: TWIICE Rise

Interventions

TWIICE Rise DEVICE

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.

Exoskeleton assisted ambulation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• TWIICE: lead
• Swiss Paraplegic Research, Nottwil: collaborator

Study Sites (1)

Swiss Paraplegic Centre Nottwil

Nottwil, Canton of Lucerne, 6207, Switzerland

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Gait Disorders, Neurologic; Paraplegia

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Paralysis

Central Study Contacts

Mario Widmer, PhD

CONTACT

+41 41 939 51 97; mario.widmer@paraplegie.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: March 10, 2026
• Study Start: July 25, 2023
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: March 10, 2026

Record last verified: 2026-03

Locations

CH (1)