Exoskeleton-based training improves walking independence in incomplete spinal cord injury patients: results from a randomized controlled trial
Abstract Background In recent years, ambulatory lower limb exoskeletons are being gradually introduced into the clinical practice to complement walking rehabilitation programs. However, the clinical evidence of the outcomes attained with these devices is still limited and nonconclusive. Furthermore,...
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| Format: | Article |
| Language: | English |
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BMC
2023-03-01
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| Series: | Journal of NeuroEngineering and Rehabilitation |
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| Online Access: | https://doi.org/10.1186/s12984-023-01158-z |
| _version_ | 1827724167294746624 |
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| author | Ángel Gil-Agudo Álvaro Megía-García José Luis Pons Isabel Sinovas-Alonso Natalia Comino-Suárez Vicente Lozano-Berrio Antonio J. del-Ama |
| author_facet | Ángel Gil-Agudo Álvaro Megía-García José Luis Pons Isabel Sinovas-Alonso Natalia Comino-Suárez Vicente Lozano-Berrio Antonio J. del-Ama |
| author_sort | Ángel Gil-Agudo |
| collection | DOAJ |
| description | Abstract Background In recent years, ambulatory lower limb exoskeletons are being gradually introduced into the clinical practice to complement walking rehabilitation programs. However, the clinical evidence of the outcomes attained with these devices is still limited and nonconclusive. Furthermore, the user-to-robot adaptation mechanisms responsible for functional improvement are still not adequately unveiled. This study aimed to (1) assess the safety and feasibility of using the HANK exoskeleton for walking rehabilitation, and (2) investigate the effects on walking function after a training program with it. Methods A randomized controlled trial was conducted including a cohort of 23 patients with less than 1 year since injury, neurological level of injury (C2-L4) and severity (American Spinal Cord Injury Association Impairment Scale [AIS] C or D). The intervention was comprised of 15 one-hour gait training sessions with lower limb exoskeleton HANK. Safety was assessed through monitoring of adverse events, and pain and fatigue through a Visual Analogue Scale. LEMS, WISCI-II, and SCIM-III scales were assessed, along with the 10MWT, 6MWT, and the TUG walking tests (see text for acronyms). Results No major adverse events were reported. Participants in the intervention group (IG) reported 1.8 cm (SD 1.0) for pain and 3.8 (SD 1.7) for fatigue using the VAS. Statistically significant differences were observed for the WISCI-II for both the “group” factor (F = 16.75, p < 0.001) and “group-time” interactions (F = 8.87; p < 0.01). A post-hoc analysis revealed a statistically significant increase of 3.54 points (SD 2.65, p < 0.0001) after intervention for the IG but not in the CG (0.7 points, SD 1.49, p = 0.285). No statistical differences were observed between groups for the remaining variables. Conclusions The use of HANK exoskeleton in clinical settings is safe and well-tolerated by the patients. Patients receiving treatment with the exoskeleton improved their walking independence as measured by the WISCI-II after the treatment. |
| first_indexed | 2024-03-10T22:10:54Z |
| format | Article |
| id | doaj.art-044f26f1c22947e7adcdb9d4e8618779 |
| institution | Directory Open Access Journal |
| issn | 1743-0003 |
| language | English |
| last_indexed | 2024-03-10T22:10:54Z |
| publishDate | 2023-03-01 |
| publisher | BMC |
| record_format | Article |
| series | Journal of NeuroEngineering and Rehabilitation |
| spelling | doaj.art-044f26f1c22947e7adcdb9d4e86187792023-11-19T12:35:03ZengBMCJournal of NeuroEngineering and Rehabilitation1743-00032023-03-0120111110.1186/s12984-023-01158-zExoskeleton-based training improves walking independence in incomplete spinal cord injury patients: results from a randomized controlled trialÁngel Gil-Agudo0Álvaro Megía-García1José Luis Pons2Isabel Sinovas-Alonso3Natalia Comino-Suárez4Vicente Lozano-Berrio5Antonio J. del-Ama6Biomechanics and Technical Aids Department, National Hospital for Paraplegics, SESCAMBiomechanics and Technical Aids Department, National Hospital for Paraplegics, SESCAMLegs and Walking Lab, Shirley Ryan Ability Laboratory (Formerly Rehabilitation Institute of Chicago)Biomechanics and Technical Aids Department, National Hospital for Paraplegics, SESCAMToledo Physiotherapy Research Group (GIFTO), Faculty of Physiotherapy and Nursing, Castilla La Mancha UniversityBiomechanics and Technical Aids Department, National Hospital for Paraplegics, SESCAMBiomechanics and Technical Aids Department, National Hospital for Paraplegics, SESCAMAbstract Background In recent years, ambulatory lower limb exoskeletons are being gradually introduced into the clinical practice to complement walking rehabilitation programs. However, the clinical evidence of the outcomes attained with these devices is still limited and nonconclusive. Furthermore, the user-to-robot adaptation mechanisms responsible for functional improvement are still not adequately unveiled. This study aimed to (1) assess the safety and feasibility of using the HANK exoskeleton for walking rehabilitation, and (2) investigate the effects on walking function after a training program with it. Methods A randomized controlled trial was conducted including a cohort of 23 patients with less than 1 year since injury, neurological level of injury (C2-L4) and severity (American Spinal Cord Injury Association Impairment Scale [AIS] C or D). The intervention was comprised of 15 one-hour gait training sessions with lower limb exoskeleton HANK. Safety was assessed through monitoring of adverse events, and pain and fatigue through a Visual Analogue Scale. LEMS, WISCI-II, and SCIM-III scales were assessed, along with the 10MWT, 6MWT, and the TUG walking tests (see text for acronyms). Results No major adverse events were reported. Participants in the intervention group (IG) reported 1.8 cm (SD 1.0) for pain and 3.8 (SD 1.7) for fatigue using the VAS. Statistically significant differences were observed for the WISCI-II for both the “group” factor (F = 16.75, p < 0.001) and “group-time” interactions (F = 8.87; p < 0.01). A post-hoc analysis revealed a statistically significant increase of 3.54 points (SD 2.65, p < 0.0001) after intervention for the IG but not in the CG (0.7 points, SD 1.49, p = 0.285). No statistical differences were observed between groups for the remaining variables. Conclusions The use of HANK exoskeleton in clinical settings is safe and well-tolerated by the patients. Patients receiving treatment with the exoskeleton improved their walking independence as measured by the WISCI-II after the treatment.https://doi.org/10.1186/s12984-023-01158-zNeurological rehabilitationSpinal cord injuryRobotic exoskeletonWalking |
| spellingShingle | Ángel Gil-Agudo Álvaro Megía-García José Luis Pons Isabel Sinovas-Alonso Natalia Comino-Suárez Vicente Lozano-Berrio Antonio J. del-Ama Exoskeleton-based training improves walking independence in incomplete spinal cord injury patients: results from a randomized controlled trial Journal of NeuroEngineering and Rehabilitation Neurological rehabilitation Spinal cord injury Robotic exoskeleton Walking |
| title | Exoskeleton-based training improves walking independence in incomplete spinal cord injury patients: results from a randomized controlled trial |
| title_full | Exoskeleton-based training improves walking independence in incomplete spinal cord injury patients: results from a randomized controlled trial |
| title_fullStr | Exoskeleton-based training improves walking independence in incomplete spinal cord injury patients: results from a randomized controlled trial |
| title_full_unstemmed | Exoskeleton-based training improves walking independence in incomplete spinal cord injury patients: results from a randomized controlled trial |
| title_short | Exoskeleton-based training improves walking independence in incomplete spinal cord injury patients: results from a randomized controlled trial |
| title_sort | exoskeleton based training improves walking independence in incomplete spinal cord injury patients results from a randomized controlled trial |
| topic | Neurological rehabilitation Spinal cord injury Robotic exoskeleton Walking |
| url | https://doi.org/10.1186/s12984-023-01158-z |
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