Spinal cord injury involving the conus region often results in severe impairments in mobility, self-care, and bladder and bowel function, substantially reducing independence and quality of life. Epidural electrical stimulation (EES), combined with structured rehabilitation, has emerged as a promising neuromodulation strategy for improving functional recovery; however, evidence in patients with conus-region involvement remains limited. This exploratory cohort study aims to evaluate functional changes following EES integrated with a standardized rehabilitation program in individuals with spinal cord injury involving the conus region. Functional independence is assessed using the Spinal Cord Independence Measure (SCIM) at baseline and during follow-up. The study also evaluates changes in SCIM subdomains related to self-care, respiration and sphincter management, and mobility, while monitoring the safety of EES throughout the rehabilitation period. The findings are expected to provide preliminary evidence regarding the feasibility, safety, and potential functional benefits of combining epidural electrical stimulation with structured rehabilitation in this specific spinal cord injury population.
Study Type
OBSERVATIONAL
Enrollment
29
Participants received individualized epidural electrical stimulation delivered through an implanted epidural stimulation system in combination with a structured rehabilitation program. Stimulation parameters were adjusted according to clinical response, and rehabilitation included task-oriented exercises, balance training, standing, gait preparation, and functional mobility exercises throughout the 6-month follow-up period.
Istanbul Gelisim University
Istanbul, Istanbul, Turkey (Türkiye)
Change in Total Spinal Cord Independence Measure (SCIM) Score
The primary outcome is the change in total Spinal Cord Independence Measure (SCIM) score between baseline and the 6-month follow-up. The SCIM assesses functional independence in individuals with spinal cord injury, with scores ranging from 0 to 100; higher scores indicate greater functional independence.
Time frame: Baseline to 6 Months
Change in SCIM Self-Care Subscale Score
Assessment of changes in the SCIM Self-Care subscale score.
Time frame: Baseline to 6 Months
Change in SCIM Respiration and Sphincter Management Subscale Score
Assessment of changes in the SCIM Respiration and Sphincter Management subscale score.
Time frame: Baseline to 6 Months
Change in SCIM Mobility: Room and Toilet Subscale Score
Assessment of changes in the SCIM Mobility: Room and Toilet subscale score.
Time frame: Baseline to 6 Months
Change in SCIM Mobility: Indoors and Outdoors Subscale Score
Assessment of changes in the SCIM Mobility: Indoors and Outdoors subscale score.
Time frame: Baseline to 6 Months
Incidence of Device- or Procedure-Related Adverse Events
Occurrence of major procedure- or device-related adverse events, including wound infection, cerebrospinal fluid leak, lead migration, stimulation intolerance requiring discontinuation, revision surgery, or device explantation during the follow-up period.
Time frame: Baseline to 6 Months
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