- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02663310
Treatment for Chronic Spinal Cord Injury: Surgery With Rehabilitation vs Rehabilitation
Surgical Decompression/Untethering Combined With Weight Bearing Rehabilitation in Chronic Spinal Cord Injury Subjects
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hui Zhu, MD
- Email: kmzhuhui@sina.com
Study Locations
-
-
Yunnan
-
Kunming, Yunnan, China, 650000
- Recruiting
- Kunming Tongren Hospital
-
Contact:
- Hui Zhu, MD
- Phone Number: (86)13888092115
- Email: kmzhuhui@sina.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Surgery with 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.
|
Surgery treatment of the injured vertebra(e), internal fixation of the vertebral column, and bilateral laminectomy for epidural decompression were followed directly by neurosurgical management, including separation of the arachnoid adhesion to restore cerebrospinal fluid flow and debridement of the spinal cord necrotic tissue with concomitant intramedullary decompression.
The patients need to do intensive rehabilitation everyday.
(1)The limb comprehensive training is Kunming Locomotor exercise, 60 minutes twice per day.(2)The
exercise therapy includes sit-ups by 30 times, twice per day; half bridge exercise by 10 times, twice per day; backward flight movement by 10 times, twice per day; sling exercise training by 30 minutes, twice per day; and postural transfer functional training by 10 minutes, twice per day.
(3)The balance training include ball toss training by 10 minutes, twice per day; and balance board training by 10 minutes, twice per day.
(4)The wheelchair training will be taken 20 minutes each, twice per day.
(5)The isokinetic training needs to perform 20 minutes each, twice per day.
|
ACTIVE_COMPARATOR: Rehabilitation
All subjects will enroll for intensive rehabilitation everyday as instruction.
|
The patients need to do intensive rehabilitation everyday.
(1)The limb comprehensive training is Kunming Locomotor exercise, 60 minutes twice per day.(2)The
exercise therapy includes sit-ups by 30 times, twice per day; half bridge exercise by 10 times, twice per day; backward flight movement by 10 times, twice per day; sling exercise training by 30 minutes, twice per day; and postural transfer functional training by 10 minutes, twice per day.
(3)The balance training include ball toss training by 10 minutes, twice per day; and balance board training by 10 minutes, twice per day.
(4)The wheelchair training will be taken 20 minutes each, twice per day.
(5)The isokinetic training needs to perform 20 minutes each, twice per day.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of Kunming Locomotor Scale in 1 year
Time Frame: 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.
|
Day 0, Day 15, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, and 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of Walking Index for Spinal Cord Injury in 1 year
Time Frame: 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.
|
Day 0, Day 15, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, and 1 year
|
Change of Spinal Cord Independence Measure in 1 year
Time Frame: 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.
|
Day 0, Day 15, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, and 1 year
|
Change of American Spinal Injury Association Impairment Scale in 1 year
Time Frame: 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).
|
Day 0, Day 15, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, and 1 year
|
Change of Modified Ashworth Scale in 1 year
Time Frame: 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).
|
Day 0, Day 15, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, and 1 year
|
Change of Numerical Rating Scale in 1 year
Time Frame: 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).
|
Day 0, Day 15, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, and 1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hui Zhu, MD, Kunming Tongren Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KunmingTH_HZ_001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Spinal Cord Injuries
-
Khon Kaen UniversityUnknownInjuries, Spinal Cord
-
Universidade do Vale do ParaíbaCompletedInjuries, Spinal Cord
-
InVivo TherapeuticsTerminated
-
Ekso BionicsBurke Medical Research InstituteCompletedInjuries, Spinal CordUnited States
-
ReWalk Robotics, Inc.Unknown
-
Shepherd Center, Atlanta GACompletedInjuries, Spinal Cord
-
Wroclaw Medical UniversityInstitute of Immunology and Experimental Therapy of the Polish Academy of... and other collaboratorsUnknownComplete Spinal Cord InjuriesPoland
-
Lineage Cell Therapeutics, Inc.CompletedCervical Spinal Cord Injury | Spine Injury | Spinal Cord TraumaUnited States
Clinical Trials on Surgery
-
University of AarhusCompletedAcute Post Operative Pain | Chronic Postsurgical PainDenmark
-
International Study Group on Minimally Invasive...Fondazione CARIT; LOGIX S.r.l.Unknown
-
Peking Union Medical College HospitalCompletedPancreatic Neuroendocrine TumorsChina
-
Hospital Central de la Defensa Gómez UllaClinica Universidad de Navarra, Universidad de NavarraEnrolling by invitationRectal Cancer | PROM | Functional Bowel DisorderSpain
-
Sunnybrook Health Sciences CentreMcMaster University; Unity Health Toronto; University of Toronto; University of... and other collaboratorsCompleted
-
The Second Hospital of Shandong UniversityRecruitingLung Diseases | SurgeryChina
-
Federal University of São PauloUnknownObesity | LymphedemaBrazil
-
Shanghai Zhongshan HospitalUnknownCarcinoma, Pancreatic Ductal | Circulating Tumor CellsChina
-
The Christie NHS Foundation TrustUniversity of ManchesterRecruitingQuality of Life | Lung NeoplasmsUnited Kingdom
-
Spinal Surgery Clinic, SträngnäsCompletedLow Back Pain | Pelvic Pain