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

NCT07036107 | Recruiting

• 1 other identifier: Robotic-SNS
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (25)

• 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)

  Baseline , end of treatment (at 8 weeks), and follow-up (2 months after end of treatment)

• 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.

  Baseline, mid-training (at 4 weeks), and end of treatment (at 8 weeks)

• 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.

  Baseline, mid-training (at 4 weeks), and end of treatment (at 8 weeks)

• 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).

  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

  The trunk control will be assessed using the Trunk Assessment Scale for Spinal Cord Injury (TASS). The TASS consists of nine sitting tasks without upper-limb support: one task is static, and the other eight tasks are dynamic. Each item is assigned a score of 0-2, 0-4, or 0-6 for a total score of 44, with higher scores indicating better trunk function.

  Baseline, end of treatment (at 8 weeks), and follow-up (2 months after end of treatment)

• Change in Endurance

  Endurance will be assessed by the distance (in meters) walked during the 2-Minute Walk Test (2MWT), which evaluates walking capacity and functional mobility.

  Baseline, mid-training (at 4 weeks), and end of treatment (at 8 weeks)

• Change in Endurance

  Endurance will be assessed by the distance (in meters) walked during the 6-Minute Walk Test (6MWT), which evaluates walking capacity and functional mobility.

  Baseline, mid-training (at 4 weeks), and end of treatment (at 8 weeks)

• Change in Level of Exertion

  Perceived exertion associated with the walking test (2MWT/6MWT) will be assessed using the Borg Rating of Perceived Exertion Scale, a self-report scale ranging from 0 to 10. A score of 0 indicates no exertion, and 10 indicates maximal exertion. Higher scores represent greater perceived exertion.

  Baseline, mid-training (at 4 weeks), and end of treatment (at 8 weeks)

• Change in Gait pattern

  The gait pattern and compensatory movements will be assessed through kinetic and kinematic gait parameters collected using a 3-D gait analysis system. The Gait Deviation Index for SCI (SCI-GDI) will be calculated to evaluate the difference between the patient' gait pattern compared to the reference gait pattern. The SCI-GDI score typically ranges from 0 to 100, with 100 representing a normal gait pattern.

  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

  Bladder and bowel function will be assessed using the International Standards to document Autonomic Function following SCI (ISAFSCI), which identifies which autonomic functions (e.g., bladder, bowel) are intact, impaired, or lost.

  Baseline, end of treatment (at 8 weeks), and follow-up (2 months after end of treatment)

• Change in Bladder and Bowel function

  Bowel function will also be assessed using the Neurogenic Bowel Dysfunction score (NBD score), a self-report questionnaire. The total NBD score ranges from 0 to 47, with higher scores indicating more severe dysfunction.

  Baseline, end of treatment (at 8 weeks), and follow-up (2 months after end of treatment)

• Change in Bone density

  The Bone density will be assessed through analytical control, 24-hour urine, and dual-energy X-ray absorptiometry (DEXA) scan in the spine, hip and knee.

  At baseline and end of treatment (at 8 weeks)

• Change in Cardiovascular function

  The cardiovascular function will be asssessed by an arm ergometry test, which is a test that measures the heart's response to physical exertion. The maximum heart rate (HR) will be documented.

  At baseline and end of treatment (at 8 weeks)

• Change in Respiratory function

  The respiratory function will be assessed by a simple spirometry, which is a test that measures the volume of air exhaled in one second (FEV1) and the total volume of air exhaled forcefully (FVC).

  Baseline, end of treatment (at 8 weeks), and follow-up (2 months after end of treatment)

• Pain reduction

  The reduction in pain will be assessed using International Spinal Cord Injury Pain Basic Data Set (ISCIPBDS) which is used to document the interference of pain with physical and emotional function and sleep, probable pain diagnosis, location, intensity and duration. Each value is scored on a 0 to 10 numerical rating scale, where 0 represents no pain and 10 represents the worst pain imaginable.

  From baseline to follow-up (at 2 months after the end of treatment)

• Change in Spasticity

  The spasticity in the lower limbs will be assessed using both the Spinal Cord Assessment Tool for Spastic Reflexes (SCATS) score, which evaluates three types of spastic motor behaviors in SCI patients - clonus, flexor spasms, and extensor spasms, as well as the Modified Ashworth Scale (MAS). SCATS total score (0-9; higher = worse outcome)

  Baseline, end of treatment (at 8 weeks), and follow-up (2 months after the end of treatment)

• Change in Functional independence

  The functional independence will be assesed using the Spinal Cord Independence Measure III (SCIM III) which is a patient-reported outcome measure that evaluates three main domains: self-care, respiration and sphincter management, and mobility. The SCIM III score is calculated on a scale of 0-100, with 0 indicating complete dependence and 100 indicating complete independence.

  Baseline, end of treatment (at 8 weeks), and follow-up (2 months after the end of treatment)

• Change in Quality of Life

  Quality of life will be assessed using the 5-level EQ-5D version (EQ-5D-5L), a standardized instrument for measuring generic health status. Ranging from 1 (best possible health) to values less than 0.

  At baseline and end of treatment (at 8 weeks)

• Change in Quality of Life

  Emotional well-being will be assessed using the Hospital Anxiety and Depression Scale (HADS), which measures anxiety and depression. Score on HADS subscales (0-21 per subscale; with higher numbers indicating a greater level of anxiety or depression)

  At baseline and end of treatment (at 8 weeks)

• Change in Quality of Life

  Motivation will be assessed using the interest/enjoyment subscale of the Intrinsic Motivation Inventory (IMI). Interest/Enjoyment score on IMI subscale (1-7; where 1 represents "Not at all true" and 7 represents "Very true")

  At baseline and end of treatment (at 8 weeks)

• Burden of healthcare professionals

  The burden on healthcare professionals will be assessed using the NASA Task Load Index (NASA-TLX), a self-report questionnaire to assess work load on five 7-point scales. NASA-TLX scores can range from 0 to 100, where a higher score generally indicates a higher workload

  At end of treatment (8 weeks)

• Change in Burden of the caregiver

  The caregiver burden will be assessed using the Zarit Burden Interview, a 22-item self-report questionnaire which total score ranges from 0 to 88. The higher the value, the higher the caregiver burden.

  Baseline, end of treatment (at 8 weeks), and follow-up (2 months after the end of treatment)

• Change in Direct healthcare costs

  The medical costs including hospitalization days, transportations, specialists consultations, rehabilitation services, emergency room visits, and hospital admissions will be calculated.

  Baseline (Day 0), end of treatment (8 weeks), and follow-up (16 weeks)

• Intervention-related costs

  The costs associated to the rehabilitation sessions, treatment, and equipment during the intervention period will be calculated.

  At the end of treatment (8 weeks)

• Change in the productivity losses

  Variation in indirect costs for patient and caregiver, associated with reduced work capacity, absenteeism, or early retirement, as a result of the intervention.

  Baseline, end of treatment (at 8 weeks), and follow-up (2 months after the end of treatment)

Study Arms (2)

Robotic exoskeleton

EXPERIMENTAL

The intervention group will receive rehabilitation treatment with the ABLE Exoskeleton

Device: ABLE Exoskeleton

Conventional therapy

ACTIVE COMPARATOR

The control group will receive conventional therapy for gait rehabilitation

Other: Conventional therapy

Interventions

ABLE Exoskeleton DEVICE

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

Robotic exoskeleton

Conventional therapy OTHER

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).

Conventional therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• ABLE Human Motion S.L.: lead
• Hospital Nacional de Parapléjicos de Toledo: collaborator
• Universitat de Lleida: collaborator
• Hospital Universitari Vall d'Hebron Research Institute: collaborator

Study Sites (2)

Hospital Nacional de Parapléjicos

Toledo, Castille-La Mancha, 45071, Spain

NOT YET RECRUITING

Hospital Universitario de Vall d'Hebron

Barcelona, Catalonia, 08035, Spain

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Lluïsa Montesinos Magraner, Dr

  Hospital Universitario de Vall d'Hebron

  PRINCIPAL INVESTIGATOR

• Ana de los Reyes Guzmán, PhD

  Hospital Nacional de Parapléjicos

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lluïsa Montesinos Magraner, Dr

CONTACT

+34 620951308; lluisa.montesinos@vallhebron.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2025
• First Posted: June 25, 2025
• Study Start: January 15, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)