AzTrials
AzTrials

StrokesERFNCT03207490

Robotics for Rehabilitation of Hand and Fingers After Stroke

A study testing AMADEO 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
Search all trials

Trial summary

The major issue for a person who has suffered a stroke is the severe impairment affecting the hand and the high risk to have a poor recovery associated. Innovative approaches are needed in the next future, translating recent advances from neuro-engineering, into feasible devices for rehabilitation care. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke
What is being tested?
AMADEO
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesin 2 countries
Study dates
Jul 2014to Dec 2017
Phase
Interventional
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients suffering from first stroke, ischemic and/or hemorrhagic
  • Score between 1 and 3 at the upper-limb sub-item of the Italian version of the National Institute of Health Stroke Scale, IT-NIHSS (Pezzella et al. 2009)
  • Score lower than 100 out of a total of 126 at the Functional Independence Measure (FIM) scale.
  • Less than 45 cubes carried in one minute whit the affected hand at the Box and Bocks Test.

Who cannot join

  • Non-stabilized fractures
  • Diagnosis of depression
  • Traumatic brain Injury
  • Untreated or drug resistant seizures.
  • Severe ideomotor apraxia
  • Severe neglect
  • Patients participating in other rehabilitation treatments for the upper-limb (e.g. virtual reality treatment, motor imagery).

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Austria1 site

  • Tyromotion GmbH

    Graz, 8020

Other trials in Austria

Italy1 site

  • IRCCS San Camillo Hospital Foundation

    Venice, 30126

Other trials in Italy

About this study

Official title: sEMG Based-Rehabilitation of Hand and Fingers After Stroke

The major issue for a person who has suffered a stroke is the severe impairment affecting the hand and the high risk to have a poor recovery associated. Innovative approaches are needed in the next future, translating recent advances from neuro-engineering, into feasible devices for rehabilitation care. The FP7-EU project MYOSENS aims to translate known motor control logic from sEMG prosthetic control, to rehabilitation robotics. The target is to promote the closing of sensory-motor loop on the basis of intention to move, as detected from residual sEMG (i.e. Extensor Digitorum Communis, Flexor Digitorum Profundus).

Read the detailed description

The objectives of this pilot study are:

  • to assess whether a clinical and kinematic effect might be induced providing a closed-loop control by sEMG signal for robot (i.e. Amadeo ®) assisted therapy of hand function
  • to determine safety and feasibility of including robotic therapy into daily rehabilitation programs after stroke.

A total of 20 patients has been recruited, all of them received on daily basis 1 hour of robot therapy in adjunction to 1 hour of standard therapy. Overall the hour of robotic therapy include both subject preparation (15 minutes to place surface electrodes on the forearm and set the right position of sitting and upper limb) and delivery of exercises. The treatment protocol includes passive and active training of flexion and extension movements of the fingers. The passive part lasts 5 minutes, while the active one provides 25 total minutes divided into 5 exercises. The robot therapy lasts 15 consecutive sessions, 5 times a week, for 3 weeks.

Conditions
Stroke
Being tested
AMADEO
Keywords
Hand, Rehabilitation, sEMG
Medical subject headings
Stroke

What participants receive

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

  • AMADEODevice

    Also called Robot-assisted therapy for the hand

    Robot therapy: 1-Degrees-Of-Freedom (1DOFs) robot training for flexion and extention movements of the hand.

    Standard rehabilitation therapy includes speech, physical, occupational therapies and group activities

Study groups in NCT03207490
Study groupRoleWhat they receive
Robot groupExperimentalReceive 1 hour of AMADEO (robot-assisted therapy) for the hand and 1 hour of daily standard rehabilitation therapy
Receives: Device: AMADEO

What is being measured

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

  1. Change at Box and Block Test (BBT)

    Hand dexterity is measured by means of the BBT. The patient has to carry as much cubes as possible, one by one, from a container to another one in one minute. The test is performed with both hands.

    Measured: Before treatment, then 3 weeks after

Secondary outcomes (5)

  1. Change at Functional Independence Measure scale (FIM)

    FIM is an 18-item scale that assesses the degree of autonomy in carrying out activities of daily living (total score = 126 points).

    Measured: Before treatment, then 3 weeks after

  2. Change at Reaching Performance Scale (RPS)

    RPS assesses the ability of subjects to reach an object (a cone). The cone is placed at both 4-cm (close) and 30-cm (far) 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 (Total score = 36 points).

    Measured: Before treatment, then 3 weeks after

  3. Change at Modified Ashworth Scale (MAS)

    Spasticity is measured using the MAS of five muscles: Pectoralis major, biceps, wrist flexors, flexor digitorum superficialis, flexor digitorum profundus (Total score = 20 points).

    Measured: Before treatment, then 3 weeks after

  4. Change at Nine Hole Pegboard Test (NHPT)

    NHPT 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 sec are registered or if the patient inserted 9 pins, then the time is registered.

    Measured: Before treatment, then 3 weeks after

  5. Change at Fugl-Meyer Assessment Scale: Upper Extremity Motor Function (F-M UE)

    Motor function of the upper limb is measured by means of the Fugl-Meyer Scale. There are 3 values: 0 (severe impairment), 1 (moderate impairiment), 2 (preserved function)

    Measured: Before treatment, then 3 weeks after

Timeline

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

  1. First posted2 Jul 2017
  2. Study startJul 2014
  3. Primary completionDec 2017
  4. Study completionDec 2017

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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Intervention is provided by a robotic device for hand motion, controlled by closed loop surface electromyography (sEMG)
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03207490
Sponsor's protocol ID
Prot. 2014.14
Acronym
sERF
Status last verified
May 2018
First submitted
12 Jan 2016
Last updated
14 May 2018
Results posted
No
Data monitoring committee
No

Publications

  • Hwang CH, Seong JW, Son DS. Individual finger synchronized robot-assisted hand rehabilitation in subacute to chronic stroke: a prospective randomized clinical trial of efficacy. Clin Rehabil. 2012 Aug;26(8):696-704. doi: 10.1177/0269215511431473. Epub 2012 Jan 19.

    PubMed 22261813

  • Sale P, Lombardi V, Franceschini M. Hand robotics rehabilitation: feasibility and preliminary results of a robotic treatment in patients with hemiparesis. Stroke Res Treat. 2012;2012:820931. doi: 10.1155/2012/820931. Epub 2012 Dec 26.

    PubMed 23320252

  • Stein J, Bishop L, Gillen G, Helbok R. Robot-assisted exercise for hand weakness after stroke: a pilot study. Am J Phys Med Rehabil. 2011 Nov;90(11):887-94. doi: 10.1097/PHM.0b013e3182328623.

    PubMed 21952215

  • Takahashi CD, Der-Yeghiaian L, Le V, Motiwala RR, Cramer SC. Robot-based hand motor therapy after stroke. Brain. 2008 Feb;131(Pt 2):425-37. doi: 10.1093/brain/awm311. Epub 2007 Dec 20.

    PubMed 18156154

Questions about this trial

What is this clinical trial studying?

A study testing AMADEO 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 4 inclusion and 7 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 14 May 2018. 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.

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?

Change at Box and Block Test (BBT) (time frame: Before treatment, then 3 weeks after). 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 NCT03207490, which also lists 4 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 14 May 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
sERF Clinical Trial NCT03207490 | AzTrials