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

NCT07037628 | Not Yet Recruiting

• 1 other identifier: IRB114-106-B
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Spinal cord stimulation (SCS) combined with one-on-one physical therapy
2. 2.One-on-one physical therapy alone

Conditions

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

Keywords

ASIA B; ASIA C; ASIA D; ASIA A

Outcome Measures

Primary Outcomes (6)

• American Spinal Injury Association (ASIA) Impairment Scale

  -AIS A (Complete): S4-S5 have no sensory and motor function. -AIS B (Sensory Incomplete): S4-S5 have sensory function (light touch or pinprick sensation or deep anal pressure sensation), but no motor function. And the motor function score of more than three levels below the injury plane is 0. -AIS C (Motor Incomplete): S4-S5 have motor function (voluntary anal sphincter contraction), or the sacral ganglion has sensory function and more than half of the key muscle groups below the injury plane have a strength of less than 3 points. -AIS D (Motor Incomplete): The muscle strength of at least half of the key muscle groups below the injury plane is greater than or equal to 3 points. -AIS E (Normal): Both sensory and motor functions are tested normal.

  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)

  Grade judgment: * 0 points: No increase in muscle tension. * 1 point: Slight increase in muscle tension at the end of the joint range of motion, manifested as a sudden jam and immediate relaxation. * 1+ points: Slight increase in muscle tension in less than half of the joint range of motion, followed by minimal resistance in the remaining range of motion. * 2 points: Significant increase in muscle tension in most of the joint range of motion, but the joint can still be moved easily. * 3 points: Significant increase in muscle tension, passive movement becomes difficult. * 4 points: The joint becomes stiff in flexion or extension and cannot be moved passively.

  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

  Force application method: The assessor instructs the patient to resist with all his strength, and the assessor gradually applies force until the patient is unable to resist and collapses, and the maximum force value is recorded. Data recording: 3 measurements are performed and the average value is taken. The unit of force is pounds (lbs).

  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)

  Grade determination (scoring): Total score 0-100 points. \- Scoring principle: The higher the score, the better the patient's independence. The scoring criteria for each item are different. The core concept is to give points based on the degree of assistance required by the patient when actually performing the task. * High score: Completely independent, or only requires a small amount of assistive devices. * Medium score: Partial assistance is required (for example: verbal prompts, others preparing items, a small amount of physical assistance). * Low score: A lot of assistance is required or completely dependent on others.

  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

  Grade determination (0-20): A hierarchical scale from 0 to 20, with higher numbers representing better walking function and lower dependence. * Grade 0: The patient cannot stand or walk. * Grade 1-5: Requires physical assistance from 2 therapists and may use different types of braces. The higher the grade, the fewer braces are needed. * Grade 6-8: Requires physical assistance from 1 therapist and may use different types of braces or walkers. * Grade 9-12: No assistance from others, but requires a walker and may use different types of braces. * Grade 13-16: No assistance from others, but requires the use of two crutches and may use different types of braces. * Grade 17-19: No assistance from others, but requires the use of a single crutch or cane and may use a brace. * Grade 20: Walk 10 meters on flat ground without any physical assistance, braces or assistive devices.

  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)

  Grade determination (0-20): A hierarchical scale from 0 to 20, with higher numbers representing better walking function and lower dependence. * Grade 0: The patient cannot stand or walk. * Grade 1-5: Requires physical assistance from 2 therapists and may use different types of braces. The higher the grade, the fewer braces are needed. * Grade 6-8: Requires physical assistance from 1 therapist and may use different types of braces or walkers. * Grade 9-12: No assistance from others, but requires a walker and may use different types of braces. * Grade 13-16: No assistance from others, but requires the use of two crutches and may use different types of braces. * Grade 17-19: No assistance from others, but requires the use of a single crutch or cane and may use a brace. * Grade 20: Walk 10 meters on flat ground without any physical assistance, braces or assistive devices.

  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.

Study Arms (2)

Experimental group

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

Control group

One-on-one physical therapy only

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Currently receiving standard treatment at Hualien Tzu Chi Hospital and referred by a neurosurgeon or orthopedic surgeon for spinal cord stimulation (SCS) and/or individualized physical therapy.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lian-Cing Yan, MSPT: lead

Study Sites (1)

Buddhist Tzu Chi Medical Foundation Hualien Tzu Chi Hospital

Hualien City, Taiwan

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

LIAN-CING YAN

CONTACT

+88638561825; cingcingyan@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physical therapist

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: June 25, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)