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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Spinal cord stimulation (SCS) combined with one-on-one physical therapy | ||
| Control group | One-on-one physical therapy only |
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| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| LIAN-CING YAN | Contact | +88638561825 | 13054 | cingcingyan@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Buddhist Tzu Chi Medical Foundation Hualien Tzu Chi Hospital | Hualien City | Taiwan |
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| 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.
| 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.
| 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.
| 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. |
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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