Clinical Trial ROBERT® - Project Active Training

NCT ID: NCT04304976

Last Updated: 2021-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-27

Study Completion Date

2020-04-21

Brief Summary

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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.

Detailed Description

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Conditions

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Apoplexy; Stroke Spinal Cord Injuries Safety Usability

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Training with ROBERT® Passive

Training performed with ROBERT® in passive mode, resulting in active assistive training.

Group Type EXPERIMENTAL

ROBERT®

Intervention Type DEVICE

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

Training with ROBERT® Active

Traning performed with ROBERT® in Active mode, resulting in active resistive training.

Group Type EXPERIMENTAL

ROBERT®

Intervention Type DEVICE

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

Interventions

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ROBERT®

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

Intervention Type DEVICE

Eligibility Criteria

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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®
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lifescience-Robotics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Helle Rovsing Jørgensen, Therapist

Role: PRINCIPAL_INVESTIGATOR

Neuro Unit Nord, Denmark

Locations

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Region Hospital, Neuro Unit Nord.

Frederikshavn, North Denmark, Denmark

Site Status

Countries

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Denmark

References

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Reference Type BACKGROUND
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Reference Type BACKGROUND

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 26969343 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25790018 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29929739 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21878220 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29634915 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24867924 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26402404 (View on PubMed)

"Ét sikkert og sammenhaengende sundhedsnetvaerk for alle."

Reference Type 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.

Reference Type BACKGROUND
PMID: 24479445 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29686644 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19608100 (View on PubMed)

Other Identifiers

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N-20190038

Identifier Type: -

Identifier Source: org_study_id

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