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  4. Epidural Stimulation and Resistance Training (REST-SCI) for Overground Locomotion After Spinal Cord Injury: Randomized Clinical Trial Protocol

Epidural Stimulation and Resistance Training (REST-SCI) for Overground Locomotion After Spinal Cord Injury: Randomized Clinical Trial Protocol

J. Clin. Med., 2025 · DOI: https://doi.org/10.3390/jcm14061829 · Published: March 8, 2025

Spinal Cord InjuryNeurologyRehabilitation

Simple Explanation

This study aims to improve walking ability in people with complete spinal cord injuries using a combination of exoskeleton-assisted walking (EAW), epidural stimulation (ES), and resistance training (RT). The researchers will compare this combined approach to EAW with delayed ES and no RT. Participants will be divided into two groups: one receiving EAW+ES+RT immediately, and the other receiving EAW only initially, followed by delayed ES. The study will assess motor control, cardiovascular health, body composition, and bladder function to see if the combined approach is more effective. The study involves several phases, including screening, implantation of an epidural stimulator, and a 12-month training program. Measurements are taken at baseline, 6 months, and 12 months to track progress and compare outcomes between the two groups.

Study Duration
More than 12 months
Participants
20 male and female participants [age 18–60 years] with traumatic motor-complete SCI [2 years or more post injury], and level of injury below C5
Evidence Level
Level 1, Randomized Clinical Trial Protocol

Key Findings

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    The restoration of locomotion with ES and EAW may result in a reduction in psychosocial, cardiovascular, and metabolic bladder parameters and socioeconomic burden.
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    The addition of the resistance training paradigm may further augment the outcomes of ES on motor function in persons with SCI.
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    Percutaneous SCES appears to be a feasible and safe rehabilitation approach for the restoration of motor function in persons with SCI.

Research Summary

This randomized clinical trial protocol outlines a study to determine the effects of exoskeleton-assisted walking (EAW) combined with epidural stimulation (ES) and resistance training (RT) on volitional motor control, autonomic cardiovascular profile, body composition, and bladder function in individuals with motor-complete spinal cord injury (SCI). Twenty participants with traumatic motor-complete SCI will be randomized into either an immediate EAW + ES + RT group or a control group receiving EAW followed by delayed ES. The study involves comprehensive assessments at baseline and post-intervention time points to evaluate the effectiveness of the combined intervention. The study aims to provide evidence for a multi-level rehabilitation approach (ES + RT) compared to a single approach (ES only), potentially enhancing motor recovery, cardiovascular health, and bladder function, while also decreasing the time, number of providers, and cost necessary to enhance overground ambulation.

Practical Implications

Enhanced Motor Recovery

The combination of EAW, ES, and RT may lead to improved volitional motor control and overground stepping ability in individuals with motor-complete SCI.

Improved Cardio-Metabolic Health

The intervention could attenuate cardiovascular risk factors and improve metabolic profiles in persons with SCI.

Bladder Function Improvement

Epidural stimulation may enhance bladder function, reducing the consequences of bladder dysfunctions after SCI.

Study Limitations

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