Wearable exoskeleton-assisted walking for people with recent spinal cord injury in Spanish hospitals

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with acute or subacute spinal cord injury will be randomly assigned to 24 sessions of gait rehabilitation using the ABLE wearable exoskeleton or to conventional gait therapy. The open, parallel-group design includes baseline, mid-training (after 12 sessions), end-training (after 24 sessions), and a two-month follow-up visit. Outcomes include clinical gait and function measures plus socioeconomic endpoints such as direct healthcare costs, intervention-related costs, and caregiver burden. Participants are recruited at Vall d'Hebron University Hospital (Barcelona) and the National Hospital for Paraplegics (Toledo) within the Spanish National Health System.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital Universitario de Vall d'Hebron
  Barcelona, Catalonia, Spain Recruiting
• Hospital Nacional de Parapléjicos
  Toledo, Castille-La Mancha, Spain Not yet recruiting

Study contacts

• Principal investigator: Lluïsa Montesinos Magraner, Dr — Hospital Universitario de Vall d'Hebron
• Study coordinator: Lluïsa Montesinos Magraner, Dr
• Email: lluisa.montesinos@vallhebron.cat
• Phone: +34 620951308

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Implanted Brain-Computer Interface to Help People with Severe Arm Impairment

  We’re testing the N1 System, a fully implanted brain interface in the motor cortex with a robot, to see if it can help adults with spinal cord injury, ALS, or chronic stroke use a computer or keyboard more easily.

  Recruiting Neuralink Corp · Miami, Florida · NCT07929792

• tSCS with rehabilitation for improving movement after spinal cord injury

  This study tests whether adding rehabilitation training to transcutaneous spinal cord stimulation helps paraplegic patients regain voluntary movement after spinal cord injury.

  Recruiting Beijing Tsinghua Chang Gung Hospital · Beijing · NCT07907952

• Informational Needs of Caregivers of Patients in Neuro Rehab: Validating the QBI-R/V

  This study tests a caregiver questionnaire (QBI-R and QBI-V) to see how well it measures caregivers’ informational needs during neuromotor rehabilitation.

  Recruiting at 13 sites Istituti Clinici Scientifici Maugeri SpA · Sciacca, Agrigento and 12 other locations · NCT07903298

• Biomechanical and Perceived Effort in Manual Wheelchair Propulsion

  This study tests whether combining objective shoulder loading data with how hard people feel they’re working can reveal how difficult manual wheelchair propulsion is for users with spinal cord injury.

  Recruiting Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française · Lyon · NCT07897214

• Shockwave therapy added to toxin injections to help spasticity after spinal cord injury

  Aims to see if focused shockwave therapy plus Botox injections reduce spasticity better than Botox alone in adults with spinal cord injury.

  Recruiting Phase 2 Kessler Foundation · West Orange, New Jersey · NCT07894991

• Vibratory Genital Nerve Stimulation to Help Female Sexual Function After Spinal Cord Injury

  This study tests whether a home-use vibration device can improve sexual function in cisgender women with spinal cord injury by increasing genital blood flow during arousal.

  Recruiting Hennepin Healthcare Research Institute · Minneapolis, Minnesota · NCT07870642

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.