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| Name | Class |
|---|---|
| FerRobotics Compliant Robot GmbH, Linz, Austria | UNKNOWN |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The RehaARM-Robot | Experimental | Receive 45 min of robot-assisted therapy for the shoulder and 1 hour of daily standard rehabilitation therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The RehaARM-Robot | Device | Robot therapy by using a 3-Degrees-Of-Freedom (3DOFs) robot to train the shoulder. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 3 weeks (15 sessions) |
| Reaching Performance Scale (RPS) |
| Measure | Description | Time Frame |
|---|---|---|
| Shoulder active range of movement (ROM-S) | Active range improvement for shoulder abduction and flexion are measured using the Tyromotion Pablo System. | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Turolla, MSc | IRCCS San Camillo Hospital Foundation, Venice (Italy) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FerRobotics Compliant Robot Technology GmbH | Linz | 4040 | Austria | |||
| IRCCS San Camillo Hospital Foundation |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21840917 | Result | 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. | |
| 15822545 | 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. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Standard rehabilitation therapy | Behavioral | Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities. |
|
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).
| 3 weeks (15 sessions) |
| 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). | 3 weeks (15 sessions) |
| 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. | 3 weeks (15 sessions) |
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. |
| 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 . | Smoothness is a measure of human movement coordination. Improvement of smoothness after the treatment is measured. | 3 weeks (15 sessions) |
| • 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. | 3 weeks (15 sessions) |
| • 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 | 3 weeks (15 sessions) |
| Venice |
| 30126 |
| Italy |
| 24270058 | 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. |
| 22696362 | 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. |
| 21901720 | 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. |
| 23914733 | 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. |
| 17876068 | 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. |
| 20726844 | 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. |
| 11018445 | 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. |
| 23300725 | 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. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |