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
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 28, 2015
CompletedFirst Posted
Study publicly available on registry
January 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedFebruary 4, 2016
January 1, 2016
1.9 years
December 28, 2015
February 3, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change of Kunming Locomotor Scale in 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 Outcomes (5)
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
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
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
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
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
Study Arms (2)
Surgery with Rehabilitation
EXPERIMENTALSurgically 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
ACTIVE COMPARATORAll subjects will enroll for intensive rehabilitation everyday as instruction.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kunming Tongren Hospitallead
- Hong Kong Spinal Cord Injury Fundcollaborator
- China Spinal Cord Injury Networkcollaborator
Study Sites (1)
Kunming Tongren Hospital
Kunming, Yunnan, 650000, China
Related Publications (1)
Zhu H, Guest JD, Dunlop S, Xie JX, Gao S, Luo Z, Springer JE, Wu W, Young W, Poon WS, Liu S, Gao H, Yu T, Wang D, Zhou L, Wu S, Zhong L, Niu F, Wang X, Liu Y, So KF, Xu XM. Surgical intervention combined with weight-bearing walking training promotes recovery in patients with chronic spinal cord injury: a randomized controlled study. Neural Regen Res. 2024 Dec 1;19(12):2773-2784. doi: 10.4103/NRR.NRR-D-23-01198. Epub 2024 Jan 31.
PMID: 38595294DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hui Zhu, MD
Kunming Tongren Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
December 28, 2015
First Posted
January 26, 2016
Study Start
July 1, 2015
Primary Completion
June 1, 2017
Study Completion
June 1, 2018
Last Updated
February 4, 2016
Record last verified: 2016-01