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

NCT ID: NCT07037628

Last Updated: 2025-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

76 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-01

Study Completion Date

2028-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Spinal Cord Injury Spinal Cord Injury Thoracic Spinal Cord Injury/Damage Spinal Cord Injury T1-L2 Spinal Cord Stimulation (SCS) Spinal Cord Stimulation Epidural Electrical Stimulation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental group

Spinal cord stimulation (SCS) combined with one-on-one physical therapy

No interventions assigned to this group

Control group

One-on-one physical therapy only

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Lian-Cing Yan, MSPT

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Lian-Cing Yan, MSPT

Physical therapist

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Buddhist Tzu Chi Medical Foundation Hualien Tzu Chi Hospital

Hualien City, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

LIAN-CING YAN

Role: CONTACT

+88638561825 ext. 13054

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

LIAN-CING YAN

Role: primary

+88638561825 ext. 13054

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB114-106-B

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

tSCS + EksoGT in SCI Patients
NCT05921175 NOT_YET_RECRUITING NA