Safety and Feasibility of TWIICE Rise

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 24 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 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.

• 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
  • LU
    • Nottwil, LU, 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 two times a week for up to 20 weeks for a total of 24 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.	up to 26 weeks
Incidence of device deficiency [Safety]	This outcome is commonly used in healthcare for the measurement of patient safety.	up to 26 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.	up to 26 weeks
Heart rate (pre-training, when standing, and post-training) [Safety]	Used to assess whether significant changes in essential physiological functions occur following training with TWIICE Rise.	up to 10 weeks
Systolic and diastolic blood pressure (pre-training, when standing, and post-training) [Safety]	Used to assess whether significant changes in essential physiological functions occur following training with TWIICE Rise.	up to 10 weeks
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").	up to 26 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'.	up to 26 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'.	up to 26 weeks
Number of steps taken [Feasibility]	TWIICE Rise will record the number of steps, walking time, standing time, and walking distance, step frequency, mid-stride pause every session. This information will allow insight into the proportion of time spent training per session.	up to 26 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	up to 26 weeks
Type of suface walked on [Feasibility]	This indicated the feasibility of walking on different type of terrain.	up to 26 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.	up to 26 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.	up to 26 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.	up to 26 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.	up to 26 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 26 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 26 weeks
Open-ended questionnaire [Satisfaction]	Used to study design modifications requested by users and clinicians.	up to 26 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').	up to 26 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.	up to 26 weeks

Collaborators and Investigators

• Sponsor: TWIICE
• Collaborators: Swiss Paraplegic Centre Nottwil

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: June 6, 2023
• First Submitted That Met QC Criteria: June 27, 2023
• First Posted (Actual): July 3, 2023

Study Record Updates

• Last Update Posted (Actual): August 8, 2023
• Last Update Submitted That Met QC Criteria: August 3, 2023
• Last Verified: June 1, 2023

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: Central Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Nervous System Diseases; Spinal Cord Injuries; Gait Disorders, Neurologic
• Other Study ID Numbers: TWIICE_2021_15

Drug and device information, study documents

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