Clinical Trial ROBERT® - Project Active Training

Spinal Cord Injuries Clinical Trial

Official title:

Clinical Trial ROBERT® - Project Active Training

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04304976
• Other study ID #: N-20190038
• Status: Completed
• Phase: N/A
• Start date: November 27, 2019
• Est. completion date: April 21, 2020

Study information

• Verified date: March 2020
• Source: Lifescience-Robotics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: April 21, 2020
• Est. primary completion date: January 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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®

Related Conditions & MeSH terms

• Apoplexy; Stroke
• Safety
• Spinal Cord Injuries
• Usability

Intervention

Device:
• ROBERT®
Robotic Rehabilitation intervention ROBERT®, designed for early, and supplementary therapy of patients.

Locations

Country	Name	City	State
Denmark	Region Hospital, Neuro Unit Nord.	Frederikshavn	Nordjylland

Sponsors (1)

Lead Sponsor	Collaborator
Lifescience-Robotics

Country where clinical trial is conducted

Denmark, 

References & Publications (15)

"Ét sikkert og sammenhaengende sundhedsnetvaerk for alle."

"NEUROLOGICAL DISORDERS public health challenges WHO Library Cataloguing-in-Publication Data," 2006.

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. — View Citation

I. Com, Global strategy and action plan on ageing and health. 2017.

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. Review. — View 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. Review. — View 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. — View 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. Review. — View 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. Review. — View 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. — View 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. Review. — View 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. — View 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. — View 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. Review. — View 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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Active training and assistive training capabilities (3 active and 3 passive motions): evaluated as passed/not passed	Active training capabilities will be assessed, 3 active motions are planned (the therapist has to be active) by the therapist, and manually performed by hand. The resistance perceived by the therapist is then compared to the expert opinion of the therapist to evaluate if this correlates with, small, medium, and large resistance. This is evaluated as passed/not passed for all 3 motions; Active assistive training capabilities will be assessed: 3 passive motions are planned (the robot moves, the therapist follows movement), by the therapist and the robot starts performing the motions, the therapist performs a small, moderate and large assistive movement in conjunction with the robot. The results in % of activity in the path of motion are displayed, and the therapist evaluates if this is in agreement with what they would categorise as a small, moderate and large assistive movement respectively. This is evaluated as passed/not passed for all 3 motions.	Up to 19 weeks
Primary	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