Safety and Feasibility of TWIICE Rise - Phase 2

Incidence of (serious) adverse device effects [Safety]

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

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

Incidence of (serious) adverse events [Safety]

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

Heart rate (pre-training, when standing, and post-training) [Safety]

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

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").

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).

Open-ended questionnaire [Satisfaction]

Used to study design modifications requested by users and clinicians.

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').

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.