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StrokePhase 1MyoReArmNCT02321254

Myoelectric Robot-assisted Rehabilitation for the Upper Limb After Stroke

A Phase 1 study testing The RehaARM-Robot and Standard rehabilitation therapy in people with Stroke, run by IRCCS San Camillo, Venezia, Italy at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Stroke
What is being tested?
The RehaARM-Robot and Standard rehabilitation therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
2 sitesin 2 countries
Study dates
May 2014to Apr 2016
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Non-stabilized fractures
  • Diagnosis of depression
  • Traumatic brain Injury
  • Pharmacologically uncontrolled epilepsy
  • Ideomotor apraxia
  • Neglect
Show all 9Show fewer
  • 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)

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Austria1 site

  • FerRobotics Compliant Robot Technology GmbH

    Linz, 4040

Other trials in Austria

Italy1 site

  • IRCCS San Camillo Hospital Foundation

    Venice, 30126

Other trials in Italy

About this study

Official title: A Pilot Study of Active, Robot-assisted Therapy for Shoulder Rehabilitation After Stroke, Using Myoelectric Signals

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
Being tested
The RehaARM-Robot, Standard rehabilitation therapy
Keywords
Stroke, Upper limb, Robotics, Electromyography, Rehabilitation
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The RehaARM-RobotDevice

    Also called Robot-assisted therapy for the shoulder

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

  • Standard rehabilitation therapyBehavioural

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

Study groups in NCT02321254
Study groupRoleWhat they receive
The RehaARM-RobotExperimentalReceive 45 min of robot-assisted therapy for the shoulder and 1 hour of daily standard rehabilitation therapy.
Receives: Device: The RehaARM-Robot; Behavioral: Standard rehabilitation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 weeks (15 sessions)

Secondary outcomes (4)

  1. 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).

    Measured: 3 weeks (15 sessions)

  2. 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).

    Measured: 3 weeks (15 sessions)

  3. 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).

    Measured: 3 weeks (15 sessions)

  4. 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.

    Measured: 3 weeks (15 sessions)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionApr 2016
  4. Study completionApr 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02321254
Sponsor's protocol ID
Prot.2013.16
Acronym
MyoReArm
Status last verified
Jun 2017
First submitted
11 Dec 2014
Last updated
2 Jul 2017
Results posted
No

Publications

  • 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.

    PubMed 21840917

  • 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.

    PubMed 15822545

  • 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.

    PubMed 24270058

  • 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.

    PubMed 22696362

  • 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.

    PubMed 21901720

  • 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.

    PubMed 23914733

  • 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.

    PubMed 17876068

  • 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.

    PubMed 20726844

  • 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.

    PubMed 11018445

  • 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.

    PubMed 23300725

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing The RehaARM-Robot and Standard rehabilitation therapy in people with Stroke, run by IRCCS San Camillo, Venezia, Italy at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Austria, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fugl-Meyer Assessment scale - Upper Extremity (FMA-UE) (time frame: 3 weeks (15 sessions)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02321254, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.

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