Transcutaneous spinal cord stimulation combined with robotic-assisted body weight-supported treadmill training enhances motor score and gait recovery in incomplete spinal cord injury: a double-blind randomized controlled clinical trial
Abstract 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...
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BMC
2025-01-01
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| Series: | Journal of NeuroEngineering and Rehabilitation |
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| Online Access: | https://doi.org/10.1186/s12984-025-01545-8 |
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| author | Natalia Comino-Suárez Juan C. Moreno Álvaro Megía-García Antonio J. del-Ama Diego Serrano-Muñoz Juan Avendaño-Coy Ángel Gil-Agudo Mónica Alcobendas-Maestro Esther López-López Julio Gómez-Soriano |
| author_facet | Natalia Comino-Suárez Juan C. Moreno Álvaro Megía-García Antonio J. del-Ama Diego Serrano-Muñoz Juan Avendaño-Coy Ángel Gil-Agudo Mónica Alcobendas-Maestro Esther López-López Julio Gómez-Soriano |
| author_sort | Natalia Comino-Suárez |
| collection | DOAJ |
| description | Abstract 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 conducted. Twenty-seven subacute iSCI participants were randomly allocated to tSCS or sham-tSCS group. All subjects conducted a standard Lokomat walking training program of 40 sessions (5 familiarization sessions, followed by 20 sessions combined with active or sham tSCS, and finally the last 15 sessions with standard Lokomat). 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). Motor evoked potential (MEP) induced by transcranial magnetic stimulation (TMS) were also assessed for lower limb muscles. Assessments were performed before and after tSCS intervention and after 3-weeks 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 (37.5 s; p = 0.030), TUG (47.7 s; p = 0.009), and WISCI-II (3.4 points; p = 0.023) at the 1-month follow-up compared to baseline. Furthermore, the percentage of subjects who were able to walk 10 m at the follow-up was greater in the tSCS group (85.7%) compared to the sham group (43.1%; p = 0.029). Finally, a significant difference (p = 0.049) was observed in the comparison of the effects in the amplitude of the rectus femoris MEPs of tSCS group (− 0.97 mV) and the sham group (− 3.39 mV) at follow-up. Conclusions The outcomes of this study suggest that the combination of standard Lokomat training with tSCS for 20 sessions was effective for LEMS and gait recovery in subacute iSCI participants after 1 month of follow-up. Trial registration ClinicalTrials.gov (NCT05210166). |
| format | Article |
| id | doaj-art-426e158afa8d4dea9365d84f96f01251 |
| institution | Kabale University |
| issn | 1743-0003 |
| language | English |
| publishDate | 2025-01-01 |
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| series | Journal of NeuroEngineering and Rehabilitation |
| spelling | doaj-art-426e158afa8d4dea9365d84f96f012512025-02-02T12:11:48ZengBMCJournal of NeuroEngineering and Rehabilitation1743-00032025-01-0122111610.1186/s12984-025-01545-8Transcutaneous spinal cord stimulation combined with robotic-assisted body weight-supported treadmill training enhances motor score and gait recovery in incomplete spinal cord injury: a double-blind randomized controlled clinical trialNatalia Comino-Suárez0Juan C. Moreno1Álvaro Megía-García2Antonio J. del-Ama3Diego Serrano-Muñoz4Juan Avendaño-Coy5Ángel Gil-Agudo6Mónica Alcobendas-Maestro7Esther López-López8Julio Gómez-Soriano9Toledo Physiotherapy Research Group (GIFTO), Faculty of Physiotherapy and Nursing of Toledo, Universidad de Castilla-La ManchaBioRobotics Group, Center for Automation and Robotics, CSIC-UPM, Spanish National Research CouncilToledo Physiotherapy Research Group (GIFTO), Faculty of Physiotherapy and Nursing of Toledo, Universidad de Castilla-La ManchaBioengineering Systems and Technologies Research Group, School of Science and Technology, Rey Juan Carlos UniversityToledo Physiotherapy Research Group (GIFTO), Faculty of Physiotherapy and Nursing of Toledo, Universidad de Castilla-La ManchaToledo Physiotherapy Research Group (GIFTO), Faculty of Physiotherapy and Nursing of Toledo, Universidad de Castilla-La ManchaUnit of Neurorehabilitation, Biomechanics and Sensorimotor Function (HNP-SESCAM), Associated Unit of R&D&I to the CSICDepartment of Physical Medicine and Rehabilitation, National Hospital for ParaplegicsDepartment of Physical Therapy, National Hospital for ParaplegicsToledo Physiotherapy Research Group (GIFTO), Faculty of Physiotherapy and Nursing of Toledo, Universidad de Castilla-La ManchaAbstract 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 conducted. Twenty-seven subacute iSCI participants were randomly allocated to tSCS or sham-tSCS group. All subjects conducted a standard Lokomat walking training program of 40 sessions (5 familiarization sessions, followed by 20 sessions combined with active or sham tSCS, and finally the last 15 sessions with standard Lokomat). 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). Motor evoked potential (MEP) induced by transcranial magnetic stimulation (TMS) were also assessed for lower limb muscles. Assessments were performed before and after tSCS intervention and after 3-weeks 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 (37.5 s; p = 0.030), TUG (47.7 s; p = 0.009), and WISCI-II (3.4 points; p = 0.023) at the 1-month follow-up compared to baseline. Furthermore, the percentage of subjects who were able to walk 10 m at the follow-up was greater in the tSCS group (85.7%) compared to the sham group (43.1%; p = 0.029). Finally, a significant difference (p = 0.049) was observed in the comparison of the effects in the amplitude of the rectus femoris MEPs of tSCS group (− 0.97 mV) and the sham group (− 3.39 mV) at follow-up. Conclusions The outcomes of this study suggest that the combination of standard Lokomat training with tSCS for 20 sessions was effective for LEMS and gait recovery in subacute iSCI participants after 1 month of follow-up. Trial registration ClinicalTrials.gov (NCT05210166).https://doi.org/10.1186/s12984-025-01545-8Spinal cord injuryTranscutaneous spinal cord stimulationLokomatRobotic-assisted gait trainingMotor functionGait rehabilitation |
| spellingShingle | Natalia Comino-Suárez Juan C. Moreno Álvaro Megía-García Antonio J. del-Ama Diego Serrano-Muñoz Juan Avendaño-Coy Ángel Gil-Agudo Mónica Alcobendas-Maestro Esther López-López Julio Gómez-Soriano Transcutaneous spinal cord stimulation combined with robotic-assisted body weight-supported treadmill training enhances motor score and gait recovery in incomplete spinal cord injury: a double-blind randomized controlled clinical trial Journal of NeuroEngineering and Rehabilitation Spinal cord injury Transcutaneous spinal cord stimulation Lokomat Robotic-assisted gait training Motor function Gait rehabilitation |
| title | Transcutaneous spinal cord stimulation combined with robotic-assisted body weight-supported treadmill training enhances motor score and gait recovery in incomplete spinal cord injury: a double-blind randomized controlled clinical trial |
| title_full | Transcutaneous spinal cord stimulation combined with robotic-assisted body weight-supported treadmill training enhances motor score and gait recovery in incomplete spinal cord injury: a double-blind randomized controlled clinical trial |
| title_fullStr | Transcutaneous spinal cord stimulation combined with robotic-assisted body weight-supported treadmill training enhances motor score and gait recovery in incomplete spinal cord injury: a double-blind randomized controlled clinical trial |
| title_full_unstemmed | Transcutaneous spinal cord stimulation combined with robotic-assisted body weight-supported treadmill training enhances motor score and gait recovery in incomplete spinal cord injury: a double-blind randomized controlled clinical trial |
| title_short | Transcutaneous spinal cord stimulation combined with robotic-assisted body weight-supported treadmill training enhances motor score and gait recovery in incomplete spinal cord injury: a double-blind randomized controlled clinical trial |
| title_sort | transcutaneous spinal cord stimulation combined with robotic assisted body weight supported treadmill training enhances motor score and gait recovery in incomplete spinal cord injury a double blind randomized controlled clinical trial |
| topic | Spinal cord injury Transcutaneous spinal cord stimulation Lokomat Robotic-assisted gait training Motor function Gait rehabilitation |
| url | https://doi.org/10.1186/s12984-025-01545-8 |
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