Safety and Feasibility of TWIICE Rise - Phase 2

TWIICE15 enrolled

Overview

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).

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

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Incidence of (serious) adverse device effects [Safety]

This outcome is commonly used in healthcare for the measurement of patient safety.

Time frame: 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

Time frame: From enrollment to the end of intervention at 10 weeks

Secondary Outcomes

Incidence of (serious) adverse events [Safety]

This outcome is commonly used in healthcare for the measurement of patient safety.

Time frame: 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

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]

Systolic and diastolic blood pressure (mmHg) will be measured using an automated upper-arm blood pressure monitor

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").

Time frame: 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'.

Time frame: 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'.

Time frame: 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.

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: up to 16 weeks

Slope inclination

Used to mesure the slope inclination on which the participants walked

Time frame: 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.

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 (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.

Time frame: Each training session from first session through end of intervention (10 weeks)

Safety and Feasibility of TWIICE Rise - Phase 2

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts