Early Surgical Intervention Combined With Weight-supported Walking Training

Kunming Tongren Hospital

Status: Completed

Conditions: Spinal Cord Injuries

Treatments: Procedure: Surgical intervention combined with weight-supported ambulation training

Study type: Interventional

Funder types: Industry

Identifiers

NCT04034108

KunmingTH_HZ_002

Details and patient eligibility

About

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).

Full 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.

Enrollment: 339 patients

Sex: All

Ages: 4 to 76 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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339 participants in 1 patient group

Experiment group

Experimental group

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.

Treatment:

Procedure: Surgical intervention combined with weight-supported ambulation training