search
Back to results

Myoelectric Robot-assisted Rehabilitation for the Upper Limb After Stroke (MyoReArm)

Primary Purpose

Stroke

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
The RehaARM-Robot
Standard rehabilitation therapy
Sponsored by
IRCCS San Camillo, Venezia, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Upper limb, Robotics, Electromyography, Rehabilitation

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Sites / Locations

  • FerRobotics Compliant Robot Technology GmbH
  • IRCCS San Camillo Hospital Foundation

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

The RehaARM-Robot

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Functional Independence Measure (FIM)
FIM is an 18-item scale that assesses patient's disability and medical rehabilitation functional outcome (A total of 126 points).
Reaching Performance Scale (RPS)
It assesses the ability of subjects to reach an object (a cone). The cone is placed at a 4-cm distance and after at a 30-cm distance from the subject. The subject is asked to reach and grab the cone if possible. The observer evaluates the quality of reaching instead of the grip strength ( A total of 36 points).
Modified Ashworth Scale (MAS) of five muscles
Spasticity is measured using the MAS of five muscles: Pectoralis major, biceps, wrist flexors, flexor digitorum superficialis, flexor digitorum profundus (Total of 20 points).
Nine Hole Pegboard Test (NHPT)
It measures the dexterity of the hand. Patient should insert 9 pins in the board. There are 9 pins. The number of pins inserted in 50 min are registered or if the patient inserted 9 pins, then the time is registered.

Full Information

First Posted
December 11, 2014
Last Updated
June 30, 2017
Sponsor
IRCCS San Camillo, Venezia, Italy
Collaborators
FerRobotics Compliant Robot GmbH, Linz, Austria
search

1. Study Identification

Unique Protocol Identification Number
NCT02321254
Brief Title
Myoelectric Robot-assisted Rehabilitation for the Upper Limb After Stroke
Acronym
MyoReArm
Official Title
A Pilot Study of Active, Robot-assisted Therapy for Shoulder Rehabilitation After Stroke, Using Myoelectric Signals
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS San Camillo, Venezia, Italy
Collaborators
FerRobotics Compliant Robot GmbH, Linz, Austria

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Upper limb, Robotics, Electromyography, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The RehaARM-Robot
Arm Type
Experimental
Arm Description
Receive 45 min of robot-assisted therapy for the shoulder and 1 hour of daily standard rehabilitation therapy.
Intervention Type
Device
Intervention Name(s)
The RehaARM-Robot
Other Intervention Name(s)
Robot-assisted therapy for the shoulder
Intervention Description
Robot therapy by using a 3-Degrees-Of-Freedom (3DOFs) robot to train the shoulder.
Intervention Type
Behavioral
Intervention Name(s)
Standard rehabilitation therapy
Intervention Description
Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities.
Primary Outcome Measure Information:
Title
Fugl-Meyer Assessment scale - Upper Extremity (FMA-UE)
Description
Motor function of the upper limb is measured by means of the Upper Extremity Motor Assessment of the Fugl-Meyer Assessment Scale.
Time Frame
3 weeks (15 sessions)
Secondary Outcome Measure Information:
Title
Functional Independence Measure (FIM)
Description
FIM is an 18-item scale that assesses patient's disability and medical rehabilitation functional outcome (A total of 126 points).
Time Frame
3 weeks (15 sessions)
Title
Reaching Performance Scale (RPS)
Description
It assesses the ability of subjects to reach an object (a cone). The cone is placed at a 4-cm distance and after at a 30-cm distance from the subject. The subject is asked to reach and grab the cone if possible. The observer evaluates the quality of reaching instead of the grip strength ( A total of 36 points).
Time Frame
3 weeks (15 sessions)
Title
Modified Ashworth Scale (MAS) of five muscles
Description
Spasticity is measured using the MAS of five muscles: Pectoralis major, biceps, wrist flexors, flexor digitorum superficialis, flexor digitorum profundus (Total of 20 points).
Time Frame
3 weeks (15 sessions)
Title
Nine Hole Pegboard Test (NHPT)
Description
It measures the dexterity of the hand. Patient should insert 9 pins in the board. There are 9 pins. The number of pins inserted in 50 min are registered or if the patient inserted 9 pins, then the time is registered.
Time Frame
3 weeks (15 sessions)
Other Pre-specified Outcome Measures:
Title
Shoulder active range of movement (ROM-S)
Description
Active range improvement for shoulder abduction and flexion are measured using the Tyromotion Pablo System.
Time Frame
3 weeks (15 sessions)
Title
• Average amount of active task repetitions of a sequence of motor tasks using the robot during a 1-hour therapy treatment.
Description
A higher number of repetitions is a paramount for neuroplasticity. The ability of subjects to execute a larger of number of motor task repetitions with the robot after the treatment is measured.
Time Frame
3 weeks (15 sessions)
Title
• 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 .
Description
Smoothness is a measure of human movement coordination. Improvement of smoothness after the treatment is measured.
Time Frame
3 weeks (15 sessions)
Title
• Average magnitude of the muscle activation during the active phase normalized by duration of the active phase (magnitude/time) for a sequence of motor tasks using the robot during a 1-hour therapy treatment.
Time Frame
3 weeks (15 sessions)
Title
• Average similarity between the muscle (synergy) modules of the paretic arm and the muscle modules of the right arm of healthy subjects for a standard sequence of motor tasks using the robot during a 1-hour therapy treatment
Time Frame
3 weeks (15 sessions)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Turolla, MSc
Organizational Affiliation
IRCCS San Camillo Hospital Foundation, Venice (Italy)
Official's Role
Principal Investigator
Facility Information:
Facility Name
FerRobotics Compliant Robot Technology GmbH
City
Linz
ZIP/Postal Code
4040
Country
Austria
Facility Name
IRCCS San Camillo Hospital Foundation
City
Venice
ZIP/Postal Code
30126
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
21840917
Citation
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.
Results Reference
result
PubMed Identifier
15822545
Citation
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.
Results Reference
result
PubMed Identifier
24270058
Citation
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.
Results Reference
result
PubMed Identifier
22696362
Citation
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.
Results Reference
result
PubMed Identifier
21901720
Citation
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.
Results Reference
result
PubMed Identifier
23914733
Citation
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.
Results Reference
result
PubMed Identifier
17876068
Citation
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.
Results Reference
result
PubMed Identifier
20726844
Citation
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.
Results Reference
result
PubMed Identifier
11018445
Citation
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.
Results Reference
result
PubMed Identifier
23300725
Citation
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.
Results Reference
result

Learn more about this trial

Myoelectric Robot-assisted Rehabilitation for the Upper Limb After Stroke

We'll reach out to this number within 24 hrs