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Trial record 20 of 284 for:    Recruiting, Not yet recruiting, Available Studies | "Spinal Cord Injuries"

Treatment for Chronic Spinal Cord Injury: Surgery With Rehabilitation vs Rehabilitation

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ClinicalTrials.gov Identifier: NCT02663310
Recruitment Status : Recruiting
First Posted : January 26, 2016
Last Update Posted : February 4, 2016
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Spinal Cord Injuries Procedure: Surgery Procedure: Rehabilitation

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Surgical Decompression/Untethering Combined With Weight Bearing Rehabilitation in Chronic Spinal Cord Injury Subjects
Study Start Date : July 2015
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2018

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U.S. FDA Resources

Arms and Interventions

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.
Procedure: 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.
Procedure: Rehabilitation
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.
Procedure: Rehabilitation
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.


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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).

  5. 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).


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02663310


Contacts
Contact: Hui Zhu, MD kmzhuhui@sina.com

Locations
China, Yunnan
Kunming Tongren Hospital Recruiting
Kunming, Yunnan, China, 650000
Contact: Hui Zhu, MD    (86)13888092115    kmzhuhui@sina.com   
Sponsors and Collaborators
Kunming Tongren Hospital
Hong Kong Spinal Cord Injury Fund
China Spinal Cord Injury Network
Investigators
Principal Investigator: Hui Zhu, MD Kunming Tongren Hospital
More Information

Additional Information:
Responsible Party: Hui Zhu, Director, Kunming Tongren Hospital
ClinicalTrials.gov Identifier: NCT02663310     History of Changes
Other Study ID Numbers: KunmingTH_HZ_001
First Posted: January 26, 2016    Key Record Dates
Last Update Posted: February 4, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Hui Zhu, Kunming Tongren Hospital:
spinal cord injury
Kunming Locomotor Scale
surgical decompression
untethering
weight bearing rehabilitation

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System