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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-70
SponsorLian-Cing Yan, MSPT

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial 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.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

76 Participants
are grouped into 2 trial groups
Group A: Experimental group
Group B: Control group

Trial outcomes

Primary outcomes

1

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.

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.
2

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.

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.
3

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).

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.
4

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.

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.

Secondary outcomes

Other outcomes

Sponsors and contacts

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Lian-Cing Yan, MSPT

Lead sponsor

Hualien Tzu Chi General Hospital

Sponsor institution

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