Treatment for Chronic Spinal Cord Injury: Surgery With Rehabilitation vs Rehabilitation
- Conditions
- Spinal Cord Injuries
- Interventions
- Procedure: SurgeryProcedure: Rehabilitation
- Registration Number
- NCT02663310
- Lead Sponsor
- Kunming Tongren Hospital
- Brief Summary
The purpose of this study is to investigate the efficacy of surgical decompression/untethering, combined with weight bearing rehabilitation, on neurological recovery following chronic spinal cord injury.
- Detailed Description
Safety Issues:
Safety issues need to be watched are: occurrence of known and unknown undesirable incidences, moving up injury levels, loss of previously preserved neurological functions, vital physical signs, and worsening of EKG and lab results. If unforeseen issues occur, patients will be consulted to determine whether treatments will be continued.
Adverse events:
Adverse events may occur during the trail and these events will be recorded. The severity of the events and their relationship to the experimental therapy will be determined, documented and reported to the Data Monitoring and Safety Committee who will determine how these events will be handled if they occur.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- Male or female adult subjects, 18-60 years of age
- Have a clinical diagnosis of chronic spinal cord injury (≥ 12 months after traumatic spinal cord injury).
- Neurological examination: ASIA-A
- Injury levels: T1-T12 spinal levels
- The diagnosis of spinal cord injury is confirmed by MRI
- Subjects must be able to read, write and complete visual analogue scale
- Voluntarily signs and dates an informed Consent form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), prior to any study-specific procedures. If a subject consents to participation but is not in a position to personally sign and date the informed consent form because of his or her physical condition, the consent must be confirmed at the time of consent orally, signed on behalf by the subject's relative, and by an impartial witness who is present throughout the whole informed consent process.
- Severe head injury
- Subjects with severe osteoporosis or joint diseases
- Subjects with severe pressure sore
- Sign of kidney, cardiovascular, liver disorders
- Subjects with internal medical and/or infectious diseases (including but not limited to Hepatitis B and HIV carriers)
- Pregnant women or women at lactation stages
- Medically or mentally unstable according to the judgment of the investigator
- History of multiple sclerosis or peripheral demyelination
- Any criteria which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Surgery with Rehabilitation Surgery Surgically removed cysts, and collected intracystic fluids and cerebrospinal fluid for histological and molecular analyses. Samples will be collected during the surgery and will be cryo-protected for further analyses. All subjects will enroll for intensive rehabilitation 60 days after surgery. Surgery with Rehabilitation Rehabilitation Surgically removed cysts, and collected intracystic fluids and cerebrospinal fluid for histological and molecular analyses. Samples will be collected during the surgery and will be cryo-protected for further analyses. All subjects will enroll for intensive rehabilitation 60 days after surgery. Rehabilitation Rehabilitation All subjects will enroll for intensive rehabilitation everyday as instruction.
- Primary Outcome Measures
Name Time Method Change of Kunming Locomotor Scale in 1 year Day 0, Day 15, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, and 1 year Kunming Locomotor Scale is a 10-grade Roman numeral locomotion scoring system. Grade I, the patient can not stand; grade II, the patient was able to stand with weight support and help in fixing the knee; grade III, the patient was able to stand with weight support; grade IV, the patient was able to walk with wheeled weight support and help in fixing the knee of the weight bearing leg; grade V, the patient was able to walk with wheeled weight support; grade VI, the patient was able to walk with the help of a light four-leg support; grade VII, the patient was able to walk with a pair of crutches; grade VIII, the patient was able to walk with a cane; grade IX, the patient was able to walk without support but staggeringly; and grade X, the patient was able to walk stably without support.
- Secondary Outcome Measures
Name Time Method Change of Numerical Rating Scale in 1 year Day 0, Day 15, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, and 1 year The Numerical Rating Scale is to assess pain intensity in patients who are able to self report ranging from 0 (no pain) to 10(unbearable pain).
Change of Modified Ashworth Scale in 1 year Day 0, Day 15, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, and 1 year Modified Ashworth Scale is considered the primary clinical measure of muscle spasticity in patients with neurological conditions, with Grade of 0, 1, 1+, 2, 3 and 4 (from no increase in muscle tone to affected parts rigid in flexion or extension).
Change of Walking Index for Spinal Cord Injury in 1 year Day 0, Day 15, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, and 1 year The Walking Index for Spinal Cord Injury evaluates the amount of physical assistance, braces or devices required to walk at 10 meters.
Change of Spinal Cord Independence Measure in 1 year Day 0, Day 15, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, and 1 year The Spinal Cord Independence Measure assesses patients' self-care, respiration and sphincter management, and mobility abilities with a total score of zero to 100.
Change of American Spinal Injury Association Impairment Scale in 1 year Day 0, Day 15, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, and 1 year American Spinal Injury Association Impairment Scale as international standards for neurological classification of spinal cord injury, is a 5 point ordinal scale to identify patient's sensory and motor levels, from A (complete SCI) to E (normal sensory and motor function).
Trial Locations
- Locations (1)
Kunming Tongren Hospital
🇨🇳Kunming, Yunnan, China