Early Surgical Intervention Combined With Weight-supported Walking Training

NCT04034108 | Completed DMC

• 1 other identifier: KunmingTH_HZ_002
• Study Type: interventional
• Target: 339
• Locations: 1 country
• Sites: 2

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).

Conditions

Spinal Cord Injuries

Keywords

surgical intervention; decompression; walking training; functional recovery; spinal cord injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change of American Spinal Injury Association Impairment Scale (AIS)

  Before surgery (baseline), Day 15, Month 3, and Month 6

• Magnetic Resonance Imaging

  Before surgery

Study Arms (1)

Experiment group

EXPERIMENTAL

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

Interventions

Surgical intervention combined with weight-supported ambulation training PROCEDURE

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.

Experiment group

Eligibility Criteria

• Age: 4 Years - 76 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• injury levels included cervical, thoracic and lumbar spinal levels;
• neurological examination was AIS-A;
• diagnosis of SCI was confirmed by MRI.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kunming Tongren Hospital: lead

Study Sites (2)

Kunming General Hospital of Chengdu Military Command

Kunming, Yunnan, China

Location

Kunming Tongren Hospital

Kunming, Yunnan, China

Location

Related Publications (1)

• 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.

  PMID: 33229715 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Hui Zhu

  Kunming Tongren Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: July 26, 2019
• Study Start: May 1, 2000
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: July 26, 2019

Record last verified: 2019-07

Locations

CN (2)