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Rehabilitation Combining Spatiotemporal Spinal Cord Stimulation and Real-time Triggering Exoskeleton After Spinal Cord Injury

NCT06881134 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-03-20

No results posted yet for this study

Summary

Spinal cord injury (SCI) can be caused by trauma, inflammation, tumors, and other factors, often leading to issues such as impaired leg movement, abnormal sensation, and difficulties with bladder and bowel control. These challenges significantly affect the patient's quality of life. While there is currently no cure for spinal cord injury, the latest guidelines recommend spinal cord stimulation and robotic exoskeletons as effective rehabilitation methods.

Spinal cord stimulation (SCS) involves implanting a device that delivers electrical stimulations to aid in motor function recovery. Its safety and effectiveness have been proven in multiple clinical studies. For example, in 2022, a Swiss research team successfully helped three patients with severe spinal cord injuries regain the ability to stand, walk, and perform other movements, offering new hope for recovery.

A robotic exoskeleton is a wearable device that assists patients in movements like walking while promoting nerve and muscle recovery. This technology has become an increasingly important tool in spinal cord injury rehabilitation.

Recent studies have shown that combining spinal cord stimulation and robotic exoskeletons yields better outcomes. For instance, in 2023, an American research team demonstrated that after 24 weeks of combined therapy, patients could achieve independent walking or walk with the aid of assistive devices.

This study aims to combine spinal cord stimulation with robotic exoskeleton therapy to develop personalized rehabilitation plans for patients. The goal is to restore lower limb motor function and improve long-term quality of life.

Conditions

  • Spinal Cord Injury
  • Neuromodulation
  • Robot Assisted Gait Training

Interventions

DEVICE

SCS+EXS

Eligible participants will undergo implantation of the spinal cord stimulation (SCS) system. Intraoperative electrophysiological monitoring will be used to adjust stimulation parameters. SCS will be tested postoperatively to assess the patient's tolerance to stimulation and its therapeutic effects. Parameters designed to improve sensory function and bladder/bowel control will be established. All parameters will be integrated into a sequential stimulation protocol. Additionally, the simultaneous activation of the SCS and the robotic exoskeleton will be tested to ensure smooth integration. Exoskeleton-assisted training will be conducted for no less than 1 hour per day (divided into two 30-minute sessions). Other rehabilitation interventions will be provided for at least 3 hours per day. Follow-ups will be conducted at 1, 2, 3, 6, and 12 months postoperatively.

Sponsors & Collaborators

  • Xuanwu Hospital, Beijing

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-13
Primary Completion
2026-01-01
Completion
2026-03-19

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06881134 on ClinicalTrials.gov