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).
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
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
15
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.
Swiss Paraplegic Centre Nottwil
Nottwil, Canton of Lucerne, Switzerland
RECRUITINGIncidence of (serious) adverse device effects [Safety]
This outcome is commonly used in healthcare for the measurement of patient safety.
Time frame: up to 26 weeks
Incidence of device deficiency [Safety]
This outcome is commonly used in healthcare for the measurement of patient safety.
Time frame: up to 26 weeks
Incidence of (serious) adverse events [Safety]
This outcome is commonly used in healthcare for the measurement of patient safety.
Time frame: 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.
Time frame: 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.
Time frame: 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").
Time frame: up to 26 weeks
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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: 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'.
Time frame: 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.
Time frame: 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
Time frame: up to 26 weeks
Type of suface walked on [Feasibility]
This indicated the feasibility of walking on different type of terrain.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: up to 26 weeks