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

Official title

Robotic-SNS: A Multicenter, Randomized Trial on the Clinical and Socioeconomic Impact of Wearable Exoskeletons for Spinal Cord Injury Rehabilitation in the Spanish Healthcare System

Overview

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.

Detailed description

Participants will be recruited from among patients admitted to the institutions involved in the project: Vall d'Hebron University Hospital (HVH) through its research institute (VHIR) and the National Hospital for Paraplegics of Toledo (HNP), through its research foundation (FHNP). After checking the inclusion and exclusion criteria, informing the patient and signing the consent, they will be randomly distributed between the control group (CG) and the intervention group (IG). Open random parallel groups. The IG will receive rehabilitation treatment with the ABLE Exoskeleton, while the CG will receive conventional therapy for gait rehabilitation. The latter 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). For both groups, participation in the study is based on a baseline visit, the 24-session rehabilitation treatment (including mid-training and end-training assessments at 12-session and 24-session, respectively) and a follow-up visit two months after the end of the treatment. Caregiver overload will also be assessed at baseline visit, after patient's treatment and at the follow-up visit two months after patient treatment.

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).

Primary outcome measures

• Change in Walking ability [Time frame: Baseline , end of treatment (at 8 weeks), and follow-up (2 months after end of treatment)]
• Change in Balance [Time frame: Baseline, mid-training (at 4 weeks), and end of treatment (at 8 weeks)]
• Change in Gait speed [Time frame: Baseline, mid-training (at 4 weeks), and end of treatment (at 8 weeks)]
• Change in Lower Extremity Motor Score (LEMS) [Time frame: Baseline, mid-training (at 4 weeks), end of treatment (at 8 weeks), and follow-up (2 months after end of treatment)]
• Change in Trunk control [Time frame: Baseline, end of treatment (at 8 weeks), and follow-up (2 months after end of treatment)]
• Change in Endurance [Time frame: Baseline, mid-training (at 4 weeks), and end of treatment (at 8 weeks)]
• Change in Endurance [Time frame: Baseline, mid-training (at 4 weeks), and end of treatment (at 8 weeks)]
• Change in Level of Exertion [Time frame: Baseline, mid-training (at 4 weeks), and end of treatment (at 8 weeks)]
• Change in Gait pattern [Time frame: Baseline, mid-training (at 4 weeks), end of treatment (at 8 weeks), and follow-up (2 months after end of treatment)]
• Change in Bladder and Bowel function [Time frame: Baseline, end of treatment (at 8 weeks), and follow-up (2 months after end of treatment)]

Eligibility criteria

Inclusion criteria

• 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).
• range of motion (ROM) without limitations in the lower extremities (achieve at least a knee extension of 10 degrees and neutral ankle position)
• muscle spasticity in the lower extremities with a score ≤ 3 on the Modified Ashworth Scale (MAS)
• tolerate bipedalism (having stood up in the last year)
• aged between 18 and 70 years, with height between 150 cm and 190 cm, and weight less than 100 kg

Exclusion criteria

• 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
• unresolved fractures at the time of the study
• uncontrolled autonomic dysautonomia
• intolerance to exercise
• uncontrolled epilepsy
• previous experience with Robotic-Assisted Gait Training (RAGT).
• ROM restriction such as flexing or arthrodesis will be excluded
• spinal instability (or spinal orthotics unless cleared by a medical doctor).
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Spain · 2 centers

• Hospital Nacional de Parapléjicos — Toledo
• Hospital Universitario de Vall d'Hebron — Barcelona

Identifiers

NCT: NCT07036107 · Robotic-SNS

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗