Myoelectric Robot-assisted Rehabilitation for the Upper Limb After Stroke

NCT02321254 | Completed Phase 1

• 1 other identifier: Prot.2013.16
• Study Type: interventional
• Target: 10
• Locations: 2 countries
• Sites: 2

Brief Summary

The aim of this study is to assess the clinical effectiveness of the RehaARM-robot and to determine the feasibility of including robotic therapy in daily rehabilitation programmes, after stroke. Additionally, we aim to investigate the acceptance of this intervention from patients and therapists. A total of 10 patients will be recruited in this study, all the patients will receive 1 hour of standard therapy together with 45 min of robot therapy every day. The robot therapy will last 45 minutes, for 15 consecutive days within a maximum period of four weeks. Additional 15 minutes are required for placing surface electrodes on the shoulder and patient preparation. The study will include passive and active shoulder training of four movements: Horizontal abduction/adduction, abduction/adduction, internal/external rotation and flexion/extension. The passive part lasts 10 minutes and the active part 35 minutes.

Conditions

Stroke

Keywords

Stroke; Upper limb; Robotics; Electromyography; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Assessment scale - Upper Extremity (FMA-UE)

  Motor function of the upper limb is measured by means of the Upper Extremity Motor Assessment of the Fugl-Meyer Assessment Scale.

  3 weeks (15 sessions)

Secondary Outcomes (4)

• Functional Independence Measure (FIM)

  3 weeks (15 sessions)

• Reaching Performance Scale (RPS)

  3 weeks (15 sessions)

• Modified Ashworth Scale (MAS) of five muscles

  3 weeks (15 sessions)

• Nine Hole Pegboard Test (NHPT)

  3 weeks (15 sessions)

Other Outcomes (5)

• Shoulder active range of movement (ROM-S)

  3 weeks (15 sessions)

• • Average amount of active task repetitions of a sequence of motor tasks using the robot during a 1-hour therapy treatment.

  3 weeks (15 sessions)

• • Smoothness of the torque (i.e. Number of peaks of the torque, [n]) for a sequence of motor tasks using the robot during a 1-hour therapy treatment .

  3 weeks (15 sessions)

Study Arms (1)

The RehaARM-Robot

EXPERIMENTAL

Receive 45 min of robot-assisted therapy for the shoulder and 1 hour of daily standard rehabilitation therapy.

Device: The RehaARM-Robot; Behavioral: Standard rehabilitation therapy

Interventions

The RehaARM-Robot DEVICE

Robot therapy by using a 3-Degrees-Of-Freedom (3DOFs) robot to train the shoulder.

Also known as: Robot-assisted therapy for the shoulder

The RehaARM-Robot

Standard rehabilitation therapy BEHAVIORAL

Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities.

The RehaARM-Robot

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients suffering from stroke, ischemic and / or hemorrhagic
• 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

You may not qualify if:

• Non-stabilized fractures
• 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)

Sponsors & Collaborators

• IRCCS San Camillo, Venezia, Italy: lead
• FerRobotics Compliant Robot GmbH, Linz, Austria: collaborator

Study Sites (2)

FerRobotics Compliant Robot Technology GmbH

Linz, 4040, Austria

Location

IRCCS San Camillo Hospital Foundation

Venice, 30126, Italy

Location

Related Publications (10)

• 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.

  PMID: 21840917 RESULT

• 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.

  PMID: 15822545 RESULT

• 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.

  PMID: 24270058 RESULT

• 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.

  PMID: 22696362 RESULT

• 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.

  PMID: 21901720 RESULT

• 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.

  PMID: 23914733 RESULT

• 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.

  PMID: 17876068 RESULT

• 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.

  PMID: 20726844 RESULT

• 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.

  PMID: 11018445 RESULT

• 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.

  PMID: 23300725 RESULT

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Andrea Turolla, MSc

  IRCCS San Camillo Hospital Foundation, Venice (Italy)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Laboratory of Kinematics and Robotics

Study Record Dates

• First Submitted: December 11, 2014
• First Posted: December 22, 2014
• Study Start: May 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: July 2, 2017

Record last verified: 2017-06

Locations

AU (1); IT (1)