This clinical trial aims to collect evidence on the clinical benefits and the socioeconomic impact of integrating a novel wearable powered lower-limb exoskeleton for gait rehabilitation in acute/subacute spinal cord injured individuals and to evaluate the efficiency of this technology to the current standard of care in the Spanish Healthcare System (SNS).. The main questions it aims to answer are:
* Is robotic therapy for gait rehabilitation more effective and efficient than conventional therapy? * Does robotic therapy for gait rehabilitation reduce the burden on healthcare professionals and caregivers? * Does robotic therapy for gait rehabilitation reduce direct healthcare costs? * Does robotic therapy for gait rehabilitation reduce intervention-related costs?
Researchers will compare a novel wearable powered lower-limb exoskeleton for gait rehabilitation to conventional therapy to see if the robotic exoskeleton is more effective and efficient in improving clinical benefits and to assess if it reduces the burden of healthcare professionals and caregivers, as well as healthcare and intervention-related costs.
Participants will:
* Be randomized on a 1:1 basis to receive rehabilitation treatment with either the robotic exoskeleton or conventional therapy for gait recovery, 3 times a week on non-consecutive days for 8 weeks (24-session program). * Undergo a pre- and post-intervention assessment of clinical, functional, physiological, psychological, and socioeconomic variables. * Have a follow-up visit 2 months after the end of the treatment.
diagnosis of spinal cord injury (SCI) in the acute or subacute phase (< 6 months of evolution)
traumatic or non-traumatic aetiology
neurological level of the SCI between C5 and L5 for patients with American Spinal Injury Association Impairment Scale (AIS) C or D, and SCI between C7 and L5 for patients with AIS A or B.
sufficient strength in the upper extremities to handle a walker (triceps muscle score ≥ 4 according to the Medical Research Council (MRC) scale).
WISCI ≥ 15
cognitive or neurological limitations that prevent following instructions
another neurologic disorder permanently affecting gait and gait therapy (other than SCI)
grade I or higher in the European Pressure Ulcer Advisory Panel (EPUAP) in the areas of contact with the exoskeleton
Parallel
ABLE Exoskeleton
DeviceParticipants will receive a 24-session rehabilitation treatment program with the ABLE Exoskeleton, 3 times a week for up to 8 weeks
Conventional therapy
Other interventionParticipants will receive a 24-session conventional therapy program for gait rehabilitation, 3 times a week for up to 8 weeks. Conventional therapy includes joint mobilizations, strengthening of paretic muscles and re-education of walking with parallel bars, making use of the technical aids and orthoses required by the patient (KAFOs, crutches and walkers).
Change in Walking ability
The walking ability will be assessed using the Walking Index Spinal Cord Injury (WISCI) II which evaluates the amount of physical assistance needed, as well as devices required, for walking following paralysis that results from Spinal Cord Injury (SCI). The WISCI II score ranges from 0 to 20 (0: the individual is unable to walk, 20: the individual walks without assistance or devices)
Change in Balance
The balance will be assessed by the time taken to complete the Timed-Up-and-Go (TUG) test which evaluates mobility and balance.
Change in Gait speed
The gait speed will be assessed by the time taken to complete the 10 meter Walk Test (10mWT) which evaluates walking speed in meters per second over a short duration.
Change in Lower Extremity Motor Score (LEMS)
The Lower Extremity Motor Score (LEMS) evaluates motor function on a scale of 0 (no motor function) to 5 (full motor function) for 5 lower extremity muscle groups with a 50-point maximum (25 per side).
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ABLE Human Motion S.L.
Lead sponsor
Hospital Nacional de Parapléjicos de Toledo
Collaborator
Universitat de Lleida
Collaborator
Hospital Universitari Vall d'Hebron Research Institute
Collaborator
