Transcutaneous spinal cord stimulation enhances motor score and gait recovery in incomplete spinal cord injury. A double-blind randomized controlled trial

Resumen

Background: Although transcutaneous spinal cord stimulation (tSCS) has been suggested as a safe and feasible intervention for gait rehabilitation, no studies have determined its effectiveness compared to sham stimulation. Objective: To determine the effectiveness of tSCS combined with robotic-assisted gait training (RAGT) on lower limb muscle strength and walking function in incomplete spinal cord injury (iSCI) participants. Methods: A randomized, double-blind, sham-controlled clinical trial was designed. Twenty-seven subacute iSCI participants were randomly allocated to tSCS or sham-tSCS group. The intervention consisted of 20 sessions of standard Lokomat walking training enhanced with tSCS. Primary outcomes were the lower extremity motor score (LEMS) and dynamometry. Secondary outcomes included the 10-Meter Walk Test (10MWT), the Timed Up and Go test (TUG), the 6-Minute Walk test (6MWT), the Spinal Cord Independence Measure III (SCIM III) and the Walking Index for Spinal Cord Injury II (WISCI-II). Assessments were performed before and after the intervention and at 1-month follow-up. Results: Although no significant differences between groups were detected after the intervention, the tSCS group showed greater effects than the sham-tSCS group for LEMS (3.4 points; p=0.033), 10MWT (37.5s; p=0.030), TUG (47.7s; p=0.009), and WISCI-II (3.4 points; p=0.023) at the 1-month follow-up. Furthermore, the percentage of subjects who were able to walk at the follow-up was greater in the tSCS group (85.7%) compared to the sham group (43.1%; p=0.029). Conclusions: The combination of standard RAGT with tSCS for 20 sessions was effective for LEMS and gait recovery in subacute iSCI participants after one month of follow-up. Key words: Spinal cord injury; Transcutaneous spinal cord stimulation; Lokomat; Robotic-assisted gait training; Motor function; Gait rehabilitation.