Myoelectric Robot-assisted Rehabilitation for the Upper Limb After Stroke
NCT ID: NCT02321254
Last Updated: 2017-07-02
Study Results
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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COMPLETED
PHASE1
10 participants
INTERVENTIONAL
2014-05-31
2016-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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The RehaARM-Robot
Receive 45 min of robot-assisted therapy for the shoulder and 1 hour of daily standard rehabilitation therapy.
The RehaARM-Robot
Robot therapy by using a 3-Degrees-Of-Freedom (3DOFs) robot to train the shoulder.
Standard rehabilitation therapy
Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities.
Interventions
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The RehaARM-Robot
Robot therapy by using a 3-Degrees-Of-Freedom (3DOFs) robot to train the shoulder.
Standard rehabilitation therapy
Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Stroke in the left hemisphere
* Score between 1 and 3 in the upper-limb sub-item of the Italian version of the National Institute of Health Stroke Scale (IT-NIHSS) (Pezzella et al. 2009)
* Score of the Functional Independence Measure (FIM) scale (Keith et al., 1987) less than 100 out of a total of 126. This scale is used as a reference to indicate the degree of autonomy in carrying out activities of daily living (ADLs)
* Score of the upper-limb Fugl-Meyer scale (FMA) (Fugl-Meyer et al., 1975) less than 60. This scale measures the residual motor function of a person after stroke
Exclusion Criteria
* Diagnosis of depression
* Traumatic brain Injury
* Pharmacologically uncontrolled epilepsy
* Ideomotor apraxia
* Neglect
* Mini Mental State Examination (MMSE) score \<20/30
* Severe impairment of verbal comprehension, defined by a score in the Token Test (Tau points\<58/78)
* Patients participating in other rehabilitation treatments for the upper-limb (e.g. virtual reality treatment, motor imagery, etc)
18 Years
90 Years
ALL
Yes
Sponsors
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FerRobotics Compliant Robot GmbH, Linz, Austria
UNKNOWN
IRCCS San Camillo, Venezia, Italy
OTHER
Responsible Party
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Andrea Turolla
Head of Laboratory of Kinematics and Robotics
Principal Investigators
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Andrea Turolla, MSc
Role: PRINCIPAL_INVESTIGATOR
IRCCS San Camillo Hospital Foundation, Venice (Italy)
Locations
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FerRobotics Compliant Robot Technology GmbH
Linz, , Austria
IRCCS San Camillo Hospital Foundation
Venice, , Italy
Countries
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References
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Liao WW, Wu CY, Hsieh YW, Lin KC, Chang WY. Effects of robot-assisted upper limb rehabilitation on daily function and real-world arm activity in patients with chronic stroke: a randomized controlled trial. Clin Rehabil. 2012 Feb;26(2):111-20. doi: 10.1177/0269215511416383. Epub 2011 Aug 12.
Suputtitada A, Suwanwela NC, Tumvitee S. Effectiveness of constraint-induced movement therapy in chronic stroke patients. J Med Assoc Thai. 2004 Dec;87(12):1482-90.
Makowski NS, Knutson JS, Chae J, Crago PE. Functional electrical stimulation to augment poststroke reach and hand opening in the presence of voluntary effort: a pilot study. Neurorehabil Neural Repair. 2014 Mar-Apr;28(3):241-9. doi: 10.1177/1545968313505913. Epub 2013 Nov 22.
Mehrholz J, Hadrich A, Platz T, Kugler J, Pohl M. Electromechanical and robot-assisted arm training for improving generic activities of daily living, arm function, and arm muscle strength after stroke. Cochrane Database Syst Rev. 2012 Jun 13;(6):CD006876. doi: 10.1002/14651858.CD006876.pub3.
Laver KE, George S, Thomas S, Deutsch JE, Crotty M. Virtual reality for stroke rehabilitation. Cochrane Database Syst Rev. 2011 Sep 7;(9):CD008349. doi: 10.1002/14651858.CD008349.pub2.
Turolla A, Dam M, Ventura L, Tonin P, Agostini M, Zucconi C, Kiper P, Cagnin A, Piron L. Virtual reality for the rehabilitation of the upper limb motor function after stroke: a prospective controlled trial. J Neuroeng Rehabil. 2013 Aug 1;10:85. doi: 10.1186/1743-0003-10-85.
Kwakkel G, Kollen BJ, Krebs HI. Effects of robot-assisted therapy on upper limb recovery after stroke: a systematic review. Neurorehabil Neural Repair. 2008 Mar-Apr;22(2):111-21. doi: 10.1177/1545968307305457. Epub 2007 Sep 17.
Johansson BB. Current trends in stroke rehabilitation. A review with focus on brain plasticity. Acta Neurol Scand. 2011 Mar;123(3):147-59. doi: 10.1111/j.1600-0404.2010.01417.x. Epub 2010 Aug 19.
Hermens HJ, Freriks B, Disselhorst-Klug C, Rau G. Development of recommendations for SEMG sensors and sensor placement procedures. J Electromyogr Kinesiol. 2000 Oct;10(5):361-74. doi: 10.1016/s1050-6411(00)00027-4.
Sartori M, Reggiani M, Farina D, Lloyd DG. EMG-driven forward-dynamic estimation of muscle force and joint moment about multiple degrees of freedom in the human lower extremity. PLoS One. 2012;7(12):e52618. doi: 10.1371/journal.pone.0052618. Epub 2012 Dec 26.
Other Identifiers
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Prot.2013.16
Identifier Type: -
Identifier Source: org_study_id
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