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临床试验/NCT07717606
NCT07717606已完成不适用

Early Functional Change After Epidural Electrical Stimulation Combined With Structured Rehabilitation in Spinal Cord Injury With Conus-Region Involvement: An Exploratory Cohort Analysis

Istanbul Gelisim University1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2026年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
29
试验地点
1
主要终点
Change in Total Spinal Cord Independence Measure (SCIM) Score

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
17 Years 至 61 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Adults and adolescents aged 17 to 61 years.
  • Diagnosis of chronic spinal cord injury involving the conus region (T12 and/or L1).
  • Underwent epidural electrical stimulation (EES) combined with a structured rehabilitation program.
  • Available baseline and follow-up Spinal Cord Independence Measure (SCIM) assessments.
  • Provided written informed consent or consent was obtained from a legally authorized representative.

排除标准

  • Spinal cord injury without conus-region involvement.
  • Missing baseline or follow-up functional assessment data. Incomplete clinical records preventing outcome evaluation.
  • Contraindications to epidural electrical stimulation or inability to participate in the rehabilitation program.

结局指标

主要结局

Change in Total Spinal Cord Independence Measure (SCIM) Score

时间窗: Baseline to 6 Months

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.

次要结局

  • Change in SCIM Self-Care Subscale Score(Baseline to 6 Months)
  • Change in SCIM Respiration and Sphincter Management Subscale Score(Baseline to 6 Months)
  • Change in SCIM Mobility: Room and Toilet Subscale Score(Baseline to 6 Months)
  • Change in SCIM Mobility: Indoors and Outdoors Subscale Score(Baseline to 6 Months)
  • Incidence of Device- or Procedure-Related Adverse Events(Baseline to 6 Months)

研究者

发起方
Istanbul Gelisim University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Görkem Açar

Ress. Asst.

Istanbul Gelisim University

研究点 (1)

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