The primary objective of this study is to validate the safety and clinical performance of the ABLE Exoskeleton with integrated Functional Electrical Stimulation (ABLE FES) in individuals with neurological conditions that impair gait, including spinal cord injury, acquired brain injury, and multiple sclerosis.
The secondary objective is to collect preliminary data on the potential clinical and psychosocial benefits of combining robotic gait assistance with electrical stimulation.
18 to 80 years old
Diagnosis of acquired brain injury, spinal cord injury (neurological level between C5 and L2, AIS B to AIS D), or multiple sclerosis
Currently undergoing physiotherapy treatment, either as an inpatient or outpatient at the investigating center
Ability to provide informed consent
Significant osteoporosis that may increase the risk of fracture
Unresolved fractures in the pelvis or limbs, or a history of fragility fractures in the lower limbs within the past 2 years
Spinal instability (or use of spinal orthoses, unless medically approved)
Deterioration >3 points of the total in the motor score of the International Standards for the Neurological Classification of Spinal Cord Injury (ISNCSCI) in the last 4 weeks. Loss of sensation and/or motor activity above the level of injury detected that has not been evaluated by a doctor.
Single group
ABLE Exoskeleton with Functional Electrical Stimulation (ABLE FES)
DeviceA robotic lower-limb exoskeleton integrated with functional electrical stimulation (ABLE FES) used for gait rehabilitation training.
Number and type of device-related Adverse Events
To assess safety, the number of Severe Adverse Events (SAE), Adverse Events (AE), and withdrawals related to the device will be recorded and classified by type and severity throughout the study period.
Time taken to don/doff the device
The time taken to don and doff the ABLE Exoskeleton with FES will be measured during each gait training session. Donning time will start from the moment the participant is ready to transfer into the device until all straps and clips are tightened. Doffing time will start from the moment the participant begins removing the device until it is fully removed. Time will be reported in minutes and seconds.
Number of steps walked
In each gait training session, the number of steps taken with the device (step count) will be automatically measured and recorded by the device.
Distance walked
In each gait training session, the distance walked with the device will be automatically measured and recorded by the device and reported in meters.
FES tolerance
Tolerance to Functional Electrical Stimulation (FES) will be assessed using a custom single-item ordinal scale developed by the research team during each training session. Scores range from 0 to 4, where 0 = no perception (no sensation felt), 1-3 represent increasing levels of perceived stimulation, and 4 = painful (uncomfortable or painful stimulus). This scale is descriptive; higher scores indicate greater perceived stimulation intensity, with the highest score reflecting an uncomfortable or painful stimulus.
Clinical observation
Clinical observations will be assessed using a structured questionnaire developed by the research team, consisting of 4 yes/no items completed during each session.
Quebec User Evaluation of Satisfaction with assistive Technology (QUEST 2.0) score
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
Borg Rating of Perceived Exertion
The Borg Rating of Perceived Exertion (RPE) scale (0-10) will be used to evaluate perceived physical effort before and after each training session. Scores range from 0 (no exertion) to 10 (maximal exertion), with higher scores indicating greater perceived effort.
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ABLE Human Motion S.L.
Lead sponsor
therapy2people GmbH
Collaborator
