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

Primary Purpose

Spinal Cord Injuries

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Surgery
Rehabilitation
Sponsored by
Kunming Tongren Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring spinal cord injury, Kunming Locomotor Scale, surgical decompression, untethering, weight bearing rehabilitation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kunming Tongren HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Surgery with Rehabilitation

Rehabilitation

Arm Description

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.

All subjects will enroll for intensive rehabilitation everyday as instruction.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change of Walking Index for Spinal Cord Injury in 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
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
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).
Change of Modified Ashworth Scale in 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 Numerical Rating Scale in 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).

Full Information

First Posted
December 28, 2015
Last Updated
February 3, 2016
Sponsor
Kunming Tongren Hospital
Collaborators
Hong Kong Spinal Cord Injury Fund, China Spinal Cord Injury Network
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1. Study Identification

Unique Protocol Identification Number
NCT02663310
Brief Title
Treatment for Chronic Spinal Cord Injury: Surgery With Rehabilitation vs Rehabilitation
Official Title
Surgical Decompression/Untethering Combined With Weight Bearing Rehabilitation in Chronic Spinal Cord Injury Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kunming Tongren Hospital
Collaborators
Hong Kong Spinal Cord Injury Fund, China Spinal Cord Injury Network

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
spinal cord injury, Kunming Locomotor Scale, surgical decompression, untethering, weight bearing rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Surgery with Rehabilitation
Arm Type
Experimental
Arm Description
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.
Arm Title
Rehabilitation
Arm Type
Active Comparator
Arm Description
All subjects will enroll for intensive rehabilitation everyday as instruction.
Intervention Type
Procedure
Intervention Name(s)
Surgery
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of Kunming Locomotor Scale in 1 year
Description
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.
Time Frame
Day 0, Day 15, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, and 1 year
Secondary Outcome Measure Information:
Title
Change of Walking Index for Spinal Cord Injury in 1 year
Description
The Walking Index for Spinal Cord Injury evaluates the amount of physical assistance, braces or devices required to walk at 10 meters.
Time Frame
Day 0, Day 15, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, and 1 year
Title
Change of Spinal Cord Independence Measure in 1 year
Description
The Spinal Cord Independence Measure assesses patients' self-care, respiration and sphincter management, and mobility abilities with a total score of zero to 100.
Time Frame
Day 0, Day 15, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, and 1 year
Title
Change of American Spinal Injury Association Impairment Scale in 1 year
Description
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).
Time Frame
Day 0, Day 15, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, and 1 year
Title
Change of Modified Ashworth Scale in 1 year
Description
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).
Time Frame
Day 0, Day 15, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, and 1 year
Title
Change of Numerical Rating Scale in 1 year
Description
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).
Time Frame
Day 0, Day 15, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, and 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hui Zhu, MD
Email
kmzhuhui@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui Zhu, MD
Organizational Affiliation
Kunming Tongren Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kunming Tongren Hospital
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui Zhu, MD
Phone
(86)13888092115
Email
kmzhuhui@sina.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Links:
URL
http://en.kmtrh.org/
Description
International Spinal Cord Injury Treatment Center, Kunming Tongren Hospital
URL
http://www.hkscifund.org/
Description
Hong Kong Spinal Cord Injury Fund (HKSCI Fund)

Learn more about this trial

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

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