Clinical Investigation on Feasibility and Usability of the ABLE Exoskeleton Device for Individuals With Spinal Cord Injury to Perform Skills for Home and Community Environments

Level of Assistance (LoA) and time taken to don/doff the device will be measured in every session. LoA will be measured using a 6-item scale, from Total assistance to Independence. Different assistance levels are defined taking into account the degree of participation of the patient and the therapist in performing the activity.

The participant will attempt a set of skills for home and community environments every session to assess the device's usability. The therapist will record the LoA required to complete each task during every session. The best LoA-Score of all 15 tasks within 3 consecutive training sessions will be recorded and analysed (sessions 2-4, sessions 5-7, sessions 8-10, sessions 11-14, sessions 15-17, sessions 18-20).

A Home-skills-test will be performed by all participants and will consist of 10 of the skills for home and community environments, set out in a sequence to simulate daily life situations. The test will be attempted twice with a 5 min break in between, the best result will be documented. To assure safety, participants will attempt the test with assistance from the therapist as required.

For all skills of the Home-skills-test, the LoA to complete each task and the time to complete the test will be documented.

The ABLE Exoskeleton device will record the number of steps, walking time, standing time, and walking distance every session. This information will allow insight into the proportion of time spent training per session.

The ABLE Exoskeleton device will record the number of steps, walking time, standing time, and walking distance every session. This information will allow insight into the proportion of time spent training per session.

The ABLE Exoskeleton device will record the number of steps, walking time, standing time, and walking distance every session. This information will allow insight into the proportion of time spent training per session.

The ABLE Exoskeleton device will record the number of steps, walking time, standing time, and walking distance every session. This information will allow insight into the proportion of time spent training per session.

Measurement of the perceived rate of exertion. The BORG will be tested after the 6 MWT with and without the device. The BORG scale measures the subjective level of intensity in physical work on a 15-grade scale. It ranges from 6 (No exertion at all) to 20 (Maximal exertion).

The 6 Minute Walk Test (6 MWT) measures the distance a person can walk within six minutes. Several conditions are reported to perform the test. For this study we will use a 50 meter track, where the patients are walking back and forth.

The 10 Meter Walk Test (10 MWT) measures the time a person needs to walk 10 meters. The test is performed with a dynamic (flying) start with two-meter acceleration, a timed ten-meter distance and a two-meter deceleration.

Timed Up and Go Test (TUG) measures the time it takes a person to get up from a chair, walk 3 meters, turn around and sit down again. It is a widely used test to assess balance and the risk of falls in different patient groups.

The Walking Index for Spinal Cord Injury (WISCI II) assesses the extent and nature of assistance for walking 10 meters in persons with SCI. Assistance is specified as different combinations of braces, walking aids and physical assistance. The WISCI II consists of 20 levels from inability to walk to the ability to walk 10 meters without any assistance

The Spinal Cord Independence Measure (SCIM) III scale focuses on the ability to perform activities of daily living in persons with SCI. The SCIM III consists of three subscales: Self-Care, Respiratory and Sphincter Management, Mobility (room and toilet) and Mobility (indoors and outdoors, on even surface). A total score of 0 (totally dependent) to 100 (totally independent) points can be achieved

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).

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

The WHO Quality of Life-BREF (WHOQOL-BREF) is the short version of the WHOQOL-100 and is recommended for use when time is restricted or in use in clinical trials. It is a self-report questionnaire that contains 26 items and addresses 4 QOL domains: physical health, psychological health, social relationships and environment. Items are rated on a 5-point Likert scale (low score of 1, high score of 5) to determine a raw item score. Subsequently, the main score for each domain is calculated, resulting in a mean score per domain that is between 4 and 20. Finally, this mean domain score is then multiplied by 4 in order to transform the domain score into a scaled score, with a higher score indicating a higher QOL. When transformed by multiplying by 4, each domain score is then comparable to the scores in the original WHOQOL-100. Self-administration is recommended if the respondent has sufficient ability.

Participants' perceptions of the impact on their general health will be evaluated by the completion of a self-report questionnaire on the perceived impact on general health. This questionnaire has been designed by the researchers and intends to identify to what extent participants feel that the ABLE Exoskeleton is ready for home-use.