Clinical trial NCT04034108: Early Surgical Intervention Combined With Weight-supported Walking Training
Official title: Early Surgical Intervention Combined With Weight-supported Walking Training Improves Neurological and Locomotor Recoveries in 339 Clinically Complete Human Spinal Cord Injuries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: surgical intervention
decompression
walking training
functional recovery
spinal cord injury
Lead sponsor: Kunming Tongren Hospital
Sponsor class: INDUSTRY
First posted: 2019-07-26
Enrollment: 339
Sex: ALL
Minimum age (years): 4
Maximum age (years): 76
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change of Kunming Locomotor Scale (KLS)
timeFrame: Before surgery, Day 15, Month 3, and Month 6
Secondary outcomes:
measure: Change of American Spinal Injury Association Impairment Scale (AIS)
timeFrame: Before surgery (baseline), Day 15, Month 3, and Month 6
measure: Magnetic Resonance Imaging
timeFrame: Before surgery
Other outcomes:
Locations:
city: Kunming
country: China
facility: Kunming General Hospital of Chengdu Military Command
state: Yunnan
city: Kunming
country: China
facility: Kunming Tongren Hospital
state: Yunnan
Study officials:
affiliation: Kunming Tongren Hospital
name: Hui Zhu
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.