Promoting Neuroplastic Mechanisms With Modeling-based Optimization of a Novel Robot-asisted Walking Rehabilitation Therapy

Standing/walking/mobility
Online since 11 March 2026, updated 2 days ago

About this trial

The goal of this observational study is to assess the course of motor and functional gait recovery induced by Lokomat robot-assisted gait rehabilitation in patients with spinal cord injury. The main q...

Included participants

Gender
All
Age
18 - 80 years
Injury level
C5 - L1
  • Severity (AIS)?
  • AIS-C
    AIS-D
    Time since injury
    2 months - 6 months
    Healthy volunteers
    No
    C5-L1
    Additionally, participants must
    NOT have implanted electronic devices or metal implants in the skull

    What’s involved

    Type

    Observational

    Details

    Patients with spinal cord injuries referred to the robotics service for gait rehabilitation will complete 40 sessions with robotic devices. An initial assessment will determine the most appropriate device. Patients assigned to the Lokomat will undergo 20 sessions, after which they will be reassessed to determine whether to continue with an additional 20 sessions or switch to a different robotic device, based on medical criteria. This study evaluates patient progress during the 40 Lokomat sessions at pre-, mid-, and post-intervention time points. A follow-up assessment will be conducted one month after completion of the Lokomat sessions to evaluate the patient progress without robotic assistance. A descriptive analysis will be performed to characterize baseline demographic data. Descriptive statistics will also be applied to the following outcome measure groups: functional assessment, robotic gait trainer variables, pain and fatigue scales, and the therapy acceptance questionnaire. The relationship between motor evoked potential (MEP) responses, lower extremity motor scores (LEMS), and force production capacity estimated using a musculoskeletal model will be investigated. MEP responses will be classified into three groups based on responsiveness (normal, delayed, and absent), and LEMS scores will be classified into four groups. A nonparametric Spearman correlation coefficient will be used to assess the correlation between MEP responses and motor scores. Nonparametric Kruskal-Wallis tests will evaluate whether the mean response differs across the four LEMS groups. For variables that do not meet the assumptions of normality for one-way analysis of variance (ANOVA), Mann-Whitney tests with Bonferroni correction will be used as a post hoc test to determine differences in responsiveness between groups. P values \<0.05 will be considered statistically significant.

    Potential benefits

    Main benefits

    Standing/walking/mobility

    Additional benefits

    Arm/hand function

    Bladder health/function

    Bowel health

    General health

    Pain

    Spasticity

    Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more


    • Trial recruitment status
    • Ended
    • Trial start date
    • 12 Jun 2023
    • Organisation
    • BioRobotics Group - Spanish National Research Council (CSIC)
    • Trial recruitment status
    • Ended
    • Trial start date
    • 12 Jun 2023
    • Organisation
    • BioRobotics Group - Spanish National Research Council (CSIC)

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more