Early Surgical Intervention Combined With Weight-supported Walking Training

Spinal Cord Injuries Clinical Trial

Official title:

Early Surgical Intervention Combined With Weight-supported Walking Training Improves Neurological and Locomotor Recoveries in 339 Clinically Complete Human Spinal Cord Injuries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04034108
• Other study ID #: KunmingTH_HZ_002
• Status: Completed
• Phase: N/A
• Start date: May 1, 2000
• Est. completion date: May 1, 2013

Study information

• Verified date: July 2019
• Source: Kunming Tongren Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 339
• Est. completion date: May 1, 2013
• Est. primary completion date: May 1, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 76 Years

Eligibility

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.

Related Conditions & MeSH terms

• Spinal Cord Injuries

Intervention

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.

Locations

Country	Name	City	State
China	Kunming General Hospital of Chengdu Military Command	Kunming	Yunnan
China	Kunming Tongren Hospital	Kunming	Yunnan

Sponsors (1)

Lead Sponsor	Collaborator
Kunming Tongren Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Before surgery, Day 15, Month 3, and Month 6
Secondary	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).	Before surgery (baseline), Day 15, Month 3, and Month 6
Secondary	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.	Before surgery