Clinical Investigation to Validate the Safety and Performance of the ABLE Kids Device in Pediatric Patients With Neurological Gait Disorders in a Clinical Setting

To assess safety, the number of Severe Adverse Events (SAE), Adverse Events (AE) and drop-outs due to the device will be assessed and reported.

he time taken to don/doff the device will be measured in every session. Time will be measured in minutes and seconds for each activity. Donning time will start from the moment the participant is ready to transfer into the device until all the straps and clips are correctly tightened. Doffing time will start from the moment the participant starts taking off the device until they have completely removed it.

In each gait training session, the number of steps taken (step count) with the device will be automatically measured and registered by the device

In each gait training session, the distance walked (in meters) with the device will be automatically measured and registered by the device

n each gait training session, the time spent upright (in minutes) and the time spent walking (in minutes) with the device will be automatically measured and registered by the device

In each gait training session, the number of people assisting will be recorded

The Daniels Muscle Testing scale will be used to measure the strength of muscles in the lower extremities. Scores range from 0 (absence of muscle activity) to 5 (normal muscle activity)

The Gross Motor Function Measure-88 (GMFM-88) is a standardized observational instrument designed to assess changes in gross motor function in children with motor impairments. It consists of 88 items grouped into five dimensions: lying and rolling, sitting, crawling and kneeling, standing, and walking/running/jumping. Each item is scored on a 4-point ordinal scale, with higher scores indicating better gross motor performance.

The Motor Function Measure-20 (MFM-20) is a validated scale used to assess motor function in children with neuromuscular disorders. It evaluates functional abilities across three domains: standing position and transfers, axial and proximal motor function, and distal motor function. The scale consists of 20 items scored on a 4-point ordinal scale, with higher scores reflecting better motor performance.

The 10-Meter Walking Test (10MWT) test measures the time a person needs to walk 10 meters. This test will be performed in the pre-post evaluations without the device to assess the change in the walking function after the training.

The 2-Minute Walk Test (2MWT) measures the distance a person can walk in 2 minutes. This test will be assessed at baseline and at the end of the gait training program without the device to assess the change in the walking function after the training

The Modified Ashworth Scale (MAS) measures spasticity in patients with lesions to the central nervous system. The scale assigns a grade of spasticity from 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension).

The Pediatric Balance Scale (PBS) is a standardized clinical assessment used to evaluate functional balance in children. Adapted from the Berg Balance Scale, it consists of 14 tasks commonly performed in everyday activities, such as sitting, standing, reaching, turning, and transferring. Each item is scored on a 5-point scale from 0 to 4, with higher scores indicating better balance performance.

The Faces Pain Scale-Revised (FPS-R) is a self-report instrument used to assess pain intensity in children. The scale presents a series of faces representing increasing levels of pain intensity, allowing participants to select the face that best matches their pain experience. Pain location is additionally recorded based on the participant's report. Higher scores indicate greater pain intensity.

The OMNI Rating of Perceived Exertion Scale is a validated self-report measure used to assess perceived physical effort during exercise in pediatric populations. The scale combines numerical ratings with verbal descriptors and pictorial representations to help children quantify their level of exertion during physical activity. Higher scores indicate greater perceived exertion.

The Functional Independence Measure for Children (WeeFIM) is a standardized instrument used to assess functional independence in children. It evaluates performance in self-care, mobility, and cognition through 18 items scored on a 7-level scale, where 1 indicates total assistance and 7 indicates complete independence. Higher scores reflect greater functional independence in activities of daily living.

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 contributed to a change in their health. The questionnaire covers 7 categories (cardiovascular system, musculoskeletal pain, neuropathic pain, bladder and bowel, spasticity, and sleep quality) using a 7-point Likert scale to assess the change.

The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) is a 12-item outcome measure that assesses user satisfaction with two components (Device and Services) using a 5-point scale ranging from 1 (not satisfied) to 5 (very satisfied). Only the 8 items referred to the device will be evaluated from participants and the whole 12 items from the therapists to measure user satisfaction with the ABLE Exoskeleton after the training program experience

The EQ-5D-Y-5L is a standardized self-reported instrument used to assess health-related quality of life in children and adolescents. It evaluates five dimensions: mobility, looking after myself, doing usual activities, having pain or discomfort, and feeling worried, sad, or unhappy. Each dimension is rated on a 5-level scale ranging from "no problems" to "extreme problems." The instrument also includes a visual analogue scale (EQ VAS) for the participant's overall perception of their health status.