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

Summary

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.

Conditions

• Spinal Cord Injury

Interventions

DEVICE

ABLE Exoskeleton

Participants will receive a 24-session rehabilitation treatment program with the ABLE Exoskeleton, 3 times a week for up to 8 weeks

OTHER

Conventional therapy

Participants 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).

Sponsors & Collaborators

• Hospital Nacional de Parapléjicos de Toledo

  collaborator OTHER

• Universitat de Lleida

  collaborator OTHER

• Hospital Universitari Vall d'Hebron Research Institute

  collaborator OTHER

• ABLE Human Motion S.L.

  lead INDUSTRY

Principal Investigators

• Lluïsa Montesinos Magraner, Dr · Hospital Universitario de Vall d'Hebron

• Ana de los Reyes Guzmán, PhD · Hospital Nacional de Parapléjicos

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-15

Primary Completion

2027-09-30

Completion

2027-09-30

Countries

• Spain

Study Locations