Early Surgical Intervention Combined With Weight-supported Walking Training Improves Neurological and Locomotor Recoveries in 339 Clinically Complete Human Spinal Cord Injuries
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Spinal Cord Injuries
- Sponsor
- Kunming Tongren Hospital
- Enrollment
- 339
- Locations
- 2
- Primary Endpoint
- Change of Kunming Locomotor Scale (KLS)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Hui Zhu
Director of Department
Kunming Tongren Hospital
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.
Outcomes
Primary Outcomes
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 Outcomes
- Magnetic Resonance Imaging(Before surgery)
- Change of American Spinal Injury Association Impairment Scale (AIS)(Before surgery (baseline), Day 15, Month 3, and Month 6)