Safety and Feasibility of TWIICE Rise - Phase 2

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

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

Heart rate (beats per minute) will be measured using a wearable heart-rate monitor

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

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").

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'.

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'.

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.

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

This indicated the feasibility of walking on different type of terrain.

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.

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.

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.

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.

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.

Used to mesure the slope inclination on which the participants walked

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 (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.

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).

Used to study design modifications requested by users and clinicians.

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').

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.