Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 5:48 AM
Study NCT ID:
NCT07440459
Status:
COMPLETED
Last Update Posted:
2026-02-27
First Post:
2025-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Promoting Neuroplastic Mechanisms With Modeling-based Optimization of a Novel Robot-asisted Walking Rehabilitation Therapy
Sponsor:
BioRobotics Group - Spanish National Research Council (CSIC)
Organization:
Study Overview
Official Title:
Assessing and Modeling the Mechanisms of Recovery During Robot Aided Neurorehabilitation of Walking
Status:
COMPLETED
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NIMBLE
Brief Summary:
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 question it aims to answer is:
How does gait motor and functional multilevel recovery progress over time in patients with spinal cord injury?
Assessmets will be conducted at four time points: pre-intervention, mid-intervention, post-intervention, and at 1-month follow-up after the completion of robot-assisted gait rehabilitation. Data will be collected at multiple levels, including:
* Clinical tests
* Three-dimensional gait analysis with kinematic, kinetic, and electromyographic measurements
* Maximum isometric strength
* Nerve conduction parameters
How does gait motor and functional multilevel recovery progress over time in patients with spinal cord injury?
Assessmets will be conducted at four time points: pre-intervention, mid-intervention, post-intervention, and at 1-month follow-up after the completion of robot-assisted gait rehabilitation. Data will be collected at multiple levels, including:
* Clinical tests
* Three-dimensional gait analysis with kinematic, kinetic, and electromyographic measurements
* Maximum isometric strength
* Nerve conduction parameters
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: