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Early Surgical Intervention Combined With Weight-supported Walking Training

Primary Purpose

Spinal Cord Injuries

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Surgical intervention combined with weight-supported ambulation training
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 surgical intervention, decompression, walking training, functional recovery, spinal cord injury

Eligibility Criteria

4 Years - 76 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • injury levels included cervical, thoracic and lumbar spinal levels;
  • neurological examination was AIS-A;
  • diagnosis of SCI was confirmed by MRI.

Exclusion Criteria:

  • penetrating injuries that caused complete transection of the spinal cord;
  • patients with severe brain injuries or other neurological disorders;
  • patients with lower motoneuron diseases;
  • patients with other conditions including pregnancy, and significant medical, infectious, and psychiatric conditions.

Sites / Locations

  • Kunming General Hospital of Chengdu Military Command
  • Kunming Tongren Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experiment group

Arm Description

All the patients were classified as AIS-A at the time of admission to the clinical center. The MRI was performed in all cases prior to and after the surgery. Surgeries were performed between 12 hours to 30 days after trauma. At 15 days after surgery, with protection of a tailored chest-waist cast made of polyurethane 8 foam for thoracic/lumbar injuries or a neck support for cervical injuries, the patients were encouraged to start weight-supported ambulation training under careful protection by the trainers.

Outcomes

Primary Outcome Measures

Change of Kunming Locomotor Scale (KLS)
Kunming Locomotor Scale is a 10-grade Roman numeral locomotion scoring system. Grade I, the patient can not stand; grade II, the patient is able to stand with weight support and help in fixing the knee; grade III, the patient is able to stand with weight support; grade IV, the patient is able to walk with wheeled weight support and help in fixing the knee of the weight bearing leg; grade V, the patient is able to walk with wheeled weight support; grade VI, the patient is able to walk with the help of a light four-leg support; grade VII, the patient is able to walk with a pair of crutches; grade VIII, the patient is able to walk with a cane; grade IX, the patient is able to walk without support but staggeringly; and grade X, the patient is able to walk stably without support.

Secondary Outcome Measures

Change of American Spinal Injury Association Impairment Scale (AIS)
American Spinal Injury Association Impairment Scale (AIS), 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 AIS-A (complete SCI) to AIS-E (normal sensory and motor function).
Magnetic Resonance Imaging
Magnetic Resonance Imaging (MRI) are performed prior to the surgery to provided important measures determining the injury level, severity, and indication of a surgical intervention.

Full Information

First Posted
July 17, 2019
Last Updated
July 25, 2019
Sponsor
Kunming Tongren Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04034108
Brief Title
Early Surgical Intervention Combined With Weight-supported Walking Training
Official Title
Early Surgical Intervention Combined With Weight-supported Walking Training Improves Neurological and Locomotor Recoveries in 339 Clinically Complete Human Spinal Cord Injuries
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2000 (Actual)
Primary Completion Date
May 1, 2013 (Actual)
Study Completion Date
May 1, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kunming Tongren Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To determine the efficacy of a novel combinatorial treatment involving early surgical intervention and long-term weight-bearing walking training in spinal cord injury (SCI) patients clinically diagnosed as complete or American Spinal Injury Association Impairment Scale Class A (AIS-A).
Detailed Description
In the present study, the investigators reported the efficacy of a novel combinatorial approach involving early surgical intervention and long-term weight-bearing walking training in SCI patients clinically defined as complete or AIS-A. The surgical intervention involves the intradural decompression (via durotomy), and, in some cases, intraspinal decompression (via myelotomy). In addition, the investigators had developed a weight-bearing walking training program named "Kunming Locomotion Training Program (KLTP)" to train the patient to walk actively for a duration of 6 hours per day, 6 days per week for a minimum of 6 months (6-6-6 KLTP). The investigators reasoned that early surgical intradural and/or intraspinal decompression would release the intraspinal pressure and, therefore, spare surrounding tissues that would otherwise degenerate during the course of secondary injury. The investigators further reasoned that long-term weight-bearing walking training would "retrain" the residual spinal pathways facilitating recovery of locomotor function, and that a combination of the two would result in even greater functional recoveries.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
surgical intervention, decompression, walking training, functional recovery, spinal cord injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
339 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experiment group
Arm Type
Experimental
Arm Description
All the patients were classified as AIS-A at the time of admission to the clinical center. The MRI was performed in all cases prior to and after the surgery. Surgeries were performed between 12 hours to 30 days after trauma. At 15 days after surgery, with protection of a tailored chest-waist cast made of polyurethane 8 foam for thoracic/lumbar injuries or a neck support for cervical injuries, the patients were encouraged to start weight-supported ambulation training under careful protection by the trainers.
Intervention Type
Procedure
Intervention Name(s)
Surgical intervention combined with weight-supported ambulation training
Intervention Description
Surgeries were performed between 12 hours to 30 days after trauma. Internal fixation was implemented once instability of the injured spinal column was confirmed by radiology and exploration during operation. At 15 days after surgery, the patients were encouraged to start weight-supported ambulation training under careful protection by the trainers, the patients were encouraged to start weight-supported ambulation training under careful protection by the trainers. The training program was named "Kunming Locomotor Training Program (KLTP)"formulated by actively walking for a duration of 6 hours per day, 6 days per week for a minimum of 6 months.
Primary Outcome Measure Information:
Title
Change of Kunming Locomotor Scale (KLS)
Description
Kunming Locomotor Scale is a 10-grade Roman numeral locomotion scoring system. Grade I, the patient can not stand; grade II, the patient is able to stand with weight support and help in fixing the knee; grade III, the patient is able to stand with weight support; grade IV, the patient is able to walk with wheeled weight support and help in fixing the knee of the weight bearing leg; grade V, the patient is able to walk with wheeled weight support; grade VI, the patient is able to walk with the help of a light four-leg support; grade VII, the patient is able to walk with a pair of crutches; grade VIII, the patient is able to walk with a cane; grade IX, the patient is able to walk without support but staggeringly; and grade X, the patient is able to walk stably without support.
Time Frame
Before surgery, Day 15, Month 3, and Month 6
Secondary Outcome Measure Information:
Title
Change of American Spinal Injury Association Impairment Scale (AIS)
Description
American Spinal Injury Association Impairment Scale (AIS), 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 AIS-A (complete SCI) to AIS-E (normal sensory and motor function).
Time Frame
Before surgery (baseline), Day 15, Month 3, and Month 6
Title
Magnetic Resonance Imaging
Description
Magnetic Resonance Imaging (MRI) are performed prior to the surgery to provided important measures determining the injury level, severity, and indication of a surgical intervention.
Time Frame
Before surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
76 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: injury levels included cervical, thoracic and lumbar spinal levels; neurological examination was AIS-A; diagnosis of SCI was confirmed by MRI. Exclusion Criteria: penetrating injuries that caused complete transection of the spinal cord; patients with severe brain injuries or other neurological disorders; patients with lower motoneuron diseases; patients with other conditions including pregnancy, and significant medical, infectious, and psychiatric conditions.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui Zhu
Organizational Affiliation
Kunming Tongren Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kunming General Hospital of Chengdu Military Command
City
Kunming
State/Province
Yunnan
Country
China
Facility Name
Kunming Tongren Hospital
City
Kunming
State/Province
Yunnan
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
33229715
Citation
Liu Y, Xie JX, Niu F, Xu Z, Tan P, Shen C, Gao H, Liu S, Ma Z, So KF, Wu W, Chen C, Gao S, Xu XM, Zhu H. Surgical intervention combined with weight-bearing walking training improves neurological recoveries in 320 patients with clinically complete spinal cord injury: a prospective self-controlled study. Neural Regen Res. 2021 May;16(5):820-829. doi: 10.4103/1673-5374.297080.
Results Reference
derived

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Early Surgical Intervention Combined With Weight-supported Walking Training

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