Early Surgical Intervention Combined With Weight-supported Walking Training

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

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).

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Procedure: Surgical intervention combined with weight-supported ambulation training

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 Type: Interventional
• Enrollment (Actual): 339
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Yunnan
    • Kunming, Yunnan, China
      • Kunming General Hospital of Chengdu Military Command
    • Kunming, Yunnan, China
      • Kunming Tongren Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 76 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Kunming Tongren Hospital
• Investigators: Principal Investigator: Hui Zhu, Kunming Tongren Hospital

Publications and helpful links

General Publications

• Liu Y, Xie JX, Niu F, Xu Z, Tan P, Shen C, Gao H, Liu S, Ma Z, So KF, Wu W, Chen C, Gao S, Xu XM, Zhu H. Surgical intervention combined with weight-bearing walking training improves neurological recoveries in 320 patients with clinically complete spinal cord injury: a prospective self-controlled study. Neural Regen Res. 2021 May;16(5):820-829. doi: 10.4103/1673-5374.297080.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2000
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: July 17, 2019
• First Submitted That Met QC Criteria: July 25, 2019
• First Posted (Actual): July 26, 2019

Study Record Updates

• Last Update Posted (Actual): July 26, 2019
• Last Update Submitted That Met QC Criteria: July 25, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: spinal cord injury; surgical intervention; decompression; walking training; functional recovery
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: KunmingTH_HZ_002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No