Early Surgical Intervention Combined With Weight-supported Walking Training

Not Applicable

Completed

• Conditions: Spinal Cord Injuries
• Interventions: Procedure: Surgical intervention combined with weight-supported ambulation training

• Registration Number: NCT04034108
• Lead Sponsor: 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).

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.

Study Timeline

• Study Start: 2000-05-01
• Primary Completion: 2013-05-01
• Study Completion: 2013-05-01
• Status Verified: 2019-07
• Study First Submitted: 2019-07-17
• Study First Submitted QC: 2019-07-25
• Last Update Submitted: 2019-07-25
• Study First Posted: 2019-07-26
• Last Update Posted: 2019-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 339

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experiment group	Surgical intervention combined with weight-supported ambulation training	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.

Primary Outcome Measures

Name	Time	Method
Change of Kunming Locomotor Scale (KLS)	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

Name	Time	Method
Magnetic Resonance Imaging	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.
Change of American Spinal Injury Association Impairment Scale (AIS)	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).

Trial Locations

Locations (2)

Kunming General Hospital of Chengdu Military Command; 🇨🇳 Kunming, Yunnan, China

Kunming Tongren Hospital; 🇨🇳 Kunming, Yunnan, China