Early Surgical Intervention Combined With Weight-supported Walking Training

NCT ID: NCT04034108

Last Updated: 2019-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 339 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-05-01
• Study Completion Date: 2013-05-01

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.

Conditions

Spinal Cord Injuries

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Surgical intervention combined with weight-supported ambulation training

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 76 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kunming Tongren Hospital

INDUSTRY

Sponsor Role: lead

Responsible Party

Hui Zhu

Director of Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hui Zhu

Role: PRINCIPAL_INVESTIGATOR

Kunming Tongren Hospital

Locations

Kunming General Hospital of Chengdu Military Command

Kunming, Yunnan, China

Kunming Tongren Hospital

Kunming, Yunnan, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 33229715 (View on PubMed)

Other Identifiers

KunmingTH_HZ_002

Identifier Type: -

Identifier Source: org_study_id