Safety and Feasibility of TWIICE Rise

NCT ID: NCT05926310

Last Updated: 2023-08-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-25
• Study Completion Date: 2024-06-30

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 24 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 24 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 a score of 29 in the Mobility SkillsTests, the following sessions can be done at home and community settings.

Conditions

Spinal Cord Injuries; Gait Disorders, Neurologic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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 two times a week for up to 20 weeks for a total of 24 sessions.

Group Type: EXPERIMENTAL

TWIICE Rise

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Swiss Paraplegic Research, Nottwil

NETWORK

Sponsor Role: collaborator

TWIICE

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Swiss Paraplegic Centre Nottwil

Nottwil, Canton of Lucerne, Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Mario Widmer, PhD

Role: CONTACT

mario.widmer@paraplegie.ch

+41 41 939 51 97

Facility Contacts

Mario Widmer, PhD

Role: primary

mario.widmer@paraplegie.ch

+41 41 939 51 97

References

Lang C, Eriks-Hoogland I, Perret C, Bouri M, Widmer M. Safety assessment and feasibility of the TWIICE powered exoskeleton for assisted ambulation in individuals with spinal cord injury. J Neuroeng Rehabil. 2025 Sep 26;22(1):194. doi: 10.1186/s12984-025-01727-4.

Reference Type: DERIVED

PMID: 41013571 (View on PubMed)

Other Identifiers

TWIICE_2021_15

Identifier Type: -

Identifier Source: org_study_id