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

Primary outcomes

1. 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.

   -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.

2. 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.

   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.

3. 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.

   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).

4. 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.

   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.

5. 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.

   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.

6. 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.

   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.