Clinical trial NCT04304976: Clinical Trial ROBERT® - Project Active Training
Official title: Clinical Trial ROBERT® - Project Active Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Apoplexy; Stroke
Spinal Cord Injuries
Safety
Usability
Lead sponsor: Lifescience-Robotics
Sponsor class: INDUSTRY
First posted: 2020-03-12
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Hospitalised patients at Neuro Unit North, during the trial period.
* 18 years or older.
* Can read, understand and speak Danish
* Reduced motor function in lower extremities.

Exclusion Criteria:

* No able to sign informed consent.
* Cannot read, understand or speak Danish
* Patients with unstable fractures in columna, pelvis or lower extremities.
* Patients with the risk of ulcers, or with exceedingly sensitive skin.
* The patient is refusing to train with ROBERT®

Primary outcomes:
measure: Active training and assistive training capabilities (3 active and 3 passive motions): evaluated as passed/not passed
timeFrame: Up to 19 weeks
measure: Safety, Capture adverse events.
timeFrame: Up to 19 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Frederikshavn
country: Denmark
facility: Region Hospital, Neuro Unit Nord.
state: Nordjylland
Study officials:
affiliation: Neuro Unit Nord, Denmark
name: Helle Rovsing Jørgensen, Therapist
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: I. Com, Global strategy and action plan on ageing and health. 2017.
citation: "NEUROLOGICAL DISORDERS public health challenges WHO Library Cataloguing-in-Publication Data," 2006.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: "Ét sikkert og sammenhaengende sundhedsnetvaerk for alle."
citation: 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.
citation: 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.
citation: 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.