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Early Surgical Intervention Combined With Weight-supported Walking Training

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ClinicalTrials.gov Identifier: NCT04034108
Recruitment Status : Completed
First Posted : July 26, 2019
Last Update Posted : July 26, 2019
Sponsor:
Information provided by (Responsible Party):
Hui Zhu, Kunming Tongren Hospital

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).

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Procedure: Surgical intervention combined with weight-supported ambulation training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 339 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Surgical Intervention Combined With Weight-supported Walking Training Improves Neurological and Locomotor Recoveries in 339 Clinically Complete Human Spinal Cord Injuries
Actual Study Start Date : May 1, 2000
Actual Primary Completion Date : May 1, 2013
Actual Study Completion Date : May 1, 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experiment group
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.
Procedure: Surgical intervention combined with weight-supported ambulation training
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 Measures :
  1. Change of Kunming Locomotor Scale (KLS) [ Time Frame: Before surgery, Day 15, Month 3, and Month 6 ]
    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 :
  1. Change of American Spinal Injury Association Impairment Scale (AIS) [ Time Frame: Before surgery (baseline), Day 15, Month 3, and Month 6 ]
    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).

  2. Magnetic Resonance Imaging [ Time Frame: Before surgery ]
    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.



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Ages Eligible for Study:   4 Years to 76 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT04034108


Locations
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China, Yunnan
Kunming General Hospital of Chengdu Military Command
Kunming, Yunnan, China
Kunming Tongren Hospital
Kunming, Yunnan, China
Sponsors and Collaborators
Kunming Tongren Hospital
Investigators
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Principal Investigator: Hui Zhu Kunming Tongren Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hui Zhu, Director of Department, Kunming Tongren Hospital
ClinicalTrials.gov Identifier: NCT04034108    
Other Study ID Numbers: KunmingTH_HZ_002
First Posted: July 26, 2019    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hui Zhu, Kunming Tongren Hospital:
surgical intervention
decompression
walking training
functional recovery
spinal cord injury
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System