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The overall purpose with this clinical trial is to, monitor and secure ROBERT®'s clinical performance and safety in a clinical environment in the regional hospital North Denmark, Neuro Unit North. The purpose of the study is to investigate if ROBERT® has the ability to 1. Perform guided active training. 2. Perform resistance based active training. And validate the safety of ROBERT® in a clinical environment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Training with ROBERT® Passive | Experimental | Training performed with ROBERT® in passive mode, resulting in active assistive training. |
|
| Training with ROBERT® Active | Experimental | Traning performed with ROBERT® in Active mode, resulting in active resistive training. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ROBERT® | Device | Robotic Rehabilitation intervention ROBERT®, designed for early, and supplementary therapy of patients. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Active training and assistive training capabilities (3 active and 3 passive motions): evaluated as passed/not passed |
| Up to 19 weeks |
| Safety, Capture adverse events. | Safety is evaluated during patient use, nr of treatment-related adverse events is recorded during training sessions. | Up to 19 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helle Rovsing Jørgensen, Therapist | Neuro Unit Nord, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Region Hospital, Neuro Unit Nord. | Frederikshavn | North Denmark | 9900 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20197531 | Background | Wunsch H, Guerra C, Barnato AE, Angus DC, Li G, Linde-Zwirble WT. Three-year outcomes for Medicare beneficiaries who survive intensive care. JAMA. 2010 Mar 3;303(9):849-56. doi: 10.1001/jama.2010.216. | |
| 21946660 | Background | Needham DM, Davidson J, Cohen H, Hopkins RO, Weinert C, Wunsch H, Zawistowski C, Bemis-Dougherty A, Berney SC, Bienvenu OJ, Brady SL, Brodsky MB, Denehy L, Elliott D, Flatley C, Harabin AL, Jones C, Louis D, Meltzer W, Muldoon SR, Palmer JB, Perme C, Robinson M, Schmidt DM, Scruth E, Spill GR, Storey CP, Render M, Votto J, Harvey MA. Improving long-term outcomes after discharge from intensive care unit: report from a stakeholders' conference. Crit Care Med. 2012 Feb;40(2):502-9. doi: 10.1097/CCM.0b013e318232da75. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Background | I. Com, Global strategy and action plan on ageing and health. 2017. |
| Background | "NEUROLOGICAL DISORDERS public health challenges WHO Library Cataloguing-in-Publication Data," 2006. |
| 26969343 | Background | Wist S, Clivaz J, Sattelmayer M. Muscle strengthening for hemiparesis after stroke: A meta-analysis. Ann Phys Rehabil Med. 2016 Apr;59(2):114-24. doi: 10.1016/j.rehab.2016.02.001. Epub 2016 Mar 8. |
| 25790018 | Background | English C, Bernhardt J, Crotty M, Esterman A, Segal L, Hillier S. Circuit class therapy or seven-day week therapy for increasing rehabilitation intensity of therapy after stroke (CIRCIT): a randomized controlled trial. Int J Stroke. 2015 Jun;10(4):594-602. doi: 10.1111/ijs.12470. Epub 2015 Mar 19. |
| 29929739 | Background | Sarkies MN, White J, Henderson K, Haas R, Bowles J; Evidence Translation in Allied Health (EviTAH) Group. Additional weekend allied health services reduce length of stay in subacute rehabilitation wards but their effectiveness and cost-effectiveness are unclear in acute general medical and surgical hospital wards: a systematic review. J Physiother. 2018 Jul;64(3):142-158. doi: 10.1016/j.jphys.2018.05.004. Epub 2018 Jun 19. |
| 21878220 | Background | Peiris CL, Taylor NF, Shields N. Extra physical therapy reduces patient length of stay and improves functional outcomes and quality of life in people with acute or subacute conditions: a systematic review. Arch Phys Med Rehabil. 2011 Sep;92(9):1490-500. doi: 10.1016/j.apmr.2011.04.005. |
| 29634915 | Background | Peiris CL, Shields N, Brusco NK, Watts JJ, Taylor NF. Additional Physical Therapy Services Reduce Length of Stay and Improve Health Outcomes in People With Acute and Subacute Conditions: An Updated Systematic Review and Meta-Analysis. Arch Phys Med Rehabil. 2018 Nov;99(11):2299-2312. doi: 10.1016/j.apmr.2018.03.005. Epub 2018 Apr 7. |
| 24867924 | Background | Lohse KR, Lang CE, Boyd LA. Is more better? Using metadata to explore dose-response relationships in stroke rehabilitation. Stroke. 2014 Jul;45(7):2053-8. doi: 10.1161/STROKEAHA.114.004695. Epub 2014 May 27. |
| 26402404 | Background | Lang CE, Lohse KR, Birkenmeier RL. Dose and timing in neurorehabilitation: prescribing motor therapy after stroke. Curr Opin Neurol. 2015 Dec;28(6):549-55. doi: 10.1097/WCO.0000000000000256. |
| Background | "Ét sikkert og sammenhaengende sundhedsnetvaerk for alle." |
| 24479445 | Background | Masiero S, Poli P, Rosati G, Zanotto D, Iosa M, Paolucci S, Morone G. The value of robotic systems in stroke rehabilitation. Expert Rev Med Devices. 2014 Mar;11(2):187-98. doi: 10.1586/17434440.2014.882766. Epub 2014 Jan 30. |
| 29686644 | Background | Semprini M, Laffranchi M, Sanguineti V, Avanzino L, De Icco R, De Michieli L, Chiappalone M. Technological Approaches for Neurorehabilitation: From Robotic Devices to Brain Stimulation and Beyond. Front Neurol. 2018 Apr 9;9:212. doi: 10.3389/fneur.2018.00212. eCollection 2018. |
| 19608100 | Background | Langhorne P, Coupar F, Pollock A. Motor recovery after stroke: a systematic review. Lancet Neurol. 2009 Aug;8(8):741-54. doi: 10.1016/S1474-4422(09)70150-4. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013118 | Spinal Cord Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |