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Not yet recruiting NCT07037628

Investigating the Impact of Spinal Cord Electrical Stimulation Combined With Individualized Physical Therapy on Lower Extremity Function in Patients With Spinal Cord Injury

— Observational Spinal Cord Injury Spinal Cord Injury Thoracic Spinal Cord Injury/Damage Spinal Cord Injury T1-L2

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Spinal Cord Injury, Spinal Cord Injury Thoracic, Spinal Cord Injury/Damage, Spinal Cord Injury T1-L2. Basic parameters: 20 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

This study aims to understand the differences in the effects of two rehabilitation approaches on lower limb function recovery in patients with spinal cord injuries: 1. Spinal cord stimulation (SCS) combined with one-on-one physical therapy 2. One-on-one physical therapy alone

Detailed description

This study adopts a prospective controlled design to observe and explore the effect of SCS combined with one-on-one physical therapy on the recovery of lower limb function in patients with spinal cord injury. The aims is to collect clinical practice data and provide reference for future related treatment strategies and care, hoping to increase the treatment options for rehabilitation of patients with spinal cord injury and improve their functional performance and quality of life.

Primary outcome measures

  • American Spinal Injury Association (ASIA) Impairment Scale [Time frame: Experimental group:To measure assessing change between pre-implant and one month after implant. Control group:To measure assessing change between Day 1 and one month after physical therapy.]
  • Modified Ashworth Scale (MAS) [Time frame: Experimental group:To measure assessing change between pre-implant and one month after implant. Control group:To measure assessing change between Day 1 and one month after physical therapy.]
  • Handheld Dynamometer [Time frame: Experimental group:To measure assessing change between pre-implant and one month after implant. Control group:To measure assessing change between Day 1 and one month after physical therapy.]
  • Spinal Cord Independence Measure (SCIM III) [Time frame: Experimental group:To measure assessing change between pre-implant and one month after implant. Control group:To measure assessing change between Day 1 and one month after physical therapy.]
  • World Health Organization Quality-of-Life Scale [Time frame: Experimental group:To measure assessing change between pre-implant and one month after implant. Control group:To measure assessing change between Day 1 and one month after physical therapy.]
  • Walking Index for Spinal Cord Injury (WISCI II) [Time frame: Experimental group:To measure assessing change between pre-implant and one month after implant. Control group:To measure assessing change between Day 1 and one month after physical therapy.]

Eligibility criteria

Inclusion criteria

  • Aged between 20 and 70 years.
  • Diagnosed with spinal cord injury, classified as ASIA Grade A-D.
  • Neurological level of injury between T1 and L2.
  • Spinal cord injury has stabilized (for at least 3 months).
  • Currently receiving standard treatment at Hualien Tzu Chi Hospital and referred by a neurosurgeon or orthopedic surgeon to receive spinal cord stimulation (SCS) and/or individualized physical therapy.
  • Capable of participating in one-on-one physical therapy sessions 3 to 5 times per week, and assessed by the medical team as able to complete at least a 3 weeks course of treatment.
  • Fully conscious, able to understand the study information, and willing to sign the consent form and participate in the full assessment process.

Exclusion criteria

  • Individuals with severe brain injury, neurodegenerative diseases, or other major neurological disorders.
  • Those with severe fractures, joint contractures, or conditions preventing participation in lower limb training.
  • Individuals with a cardiac pacemaker or who are pregnant.
  • Those unable to comply with the treatment or assessment procedures.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Taiwan · 1 center
  • Buddhist Tzu Chi Medical Foundation Hualien Tzu Chi Hospital — Hualien City

Identifiers

NCT: NCT07037628 · IRB114-106-B

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗