A Trial on the Clinical and Socioeconomic Impact of Wearable Exoskeletons for Spinal Cord Injury Rehabilitation in the Spanish Healthcare System

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorABLE Human Motion S.L.

About this trial

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.

Eligibility criteria

Qualifiers

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).

Disqualifiers

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

Trial design

Treatments tested in this trial

  • ABLE Exoskeleton
  • Conventional therapy

Treatment groups

80 Participants
are divided into 2 treatment groups

Sponsors and collaborators

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