Robotics for Rehabilitation of Hand and Fingers After Stroke (sERF)
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
AMADEO
Sponsored by

About this trial
This is an interventional treatment trial for Stroke focused on measuring Hand, Rehabilitation, sEMG
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Sites / Locations
- Tyromotion GmbH
- IRCCS San Camillo Hospital Foundation
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Robot group
Arm Description
Receive 1 hour of AMADEO (robot-assisted therapy) for the hand and 1 hour of daily standard rehabilitation therapy
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
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).
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).
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.
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)
Full Information
NCT ID
NCT03207490
First Posted
January 12, 2016
Last Updated
May 8, 2018
Sponsor
IRCCS San Camillo, Venezia, Italy
1. Study Identification
Unique Protocol Identification Number
NCT03207490
Brief Title
Robotics for Rehabilitation of Hand and Fingers After Stroke
Acronym
sERF
Official Title
sEMG Based-Rehabilitation of Hand and Fingers After Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS San Camillo, Venezia, Italy
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Hand, Rehabilitation, sEMG
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Intervention is provided by a robotic device for hand motion, controlled by closed loop surface electromyography (sEMG)
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Robot group
Arm Type
Experimental
Arm Description
Receive 1 hour of AMADEO (robot-assisted therapy) for the hand and 1 hour of daily standard rehabilitation therapy
Intervention Type
Device
Intervention Name(s)
AMADEO
Other Intervention Name(s)
Robot-assisted therapy for the hand
Intervention Description
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
Primary Outcome Measure Information:
Title
Change at Box and Block Test (BBT)
Description
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.
Time Frame
Before treatment, then 3 weeks after
Secondary Outcome Measure Information:
Title
Change at Functional Independence Measure scale (FIM)
Description
FIM is an 18-item scale that assesses the degree of autonomy in carrying out activities of daily living (total score = 126 points).
Time Frame
Before treatment, then 3 weeks after
Title
Change at Reaching Performance Scale (RPS)
Description
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).
Time Frame
Before treatment, then 3 weeks after
Title
Change at Modified Ashworth Scale (MAS)
Description
Spasticity is measured using the MAS of five muscles: Pectoralis major, biceps, wrist flexors, flexor digitorum superficialis, flexor digitorum profundus (Total score = 20 points).
Time Frame
Before treatment, then 3 weeks after
Title
Change at Nine Hole Pegboard Test (NHPT)
Description
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.
Time Frame
Before treatment, then 3 weeks after
Title
Change at Fugl-Meyer Assessment Scale: Upper Extremity Motor Function (F-M UE)
Description
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)
Time Frame
Before treatment, then 3 weeks after
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Turolla, PhD
Organizational Affiliation
IRCCS San Camillo, Venezia, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tyromotion GmbH
City
Graz
ZIP/Postal Code
8020
Country
Austria
Facility Name
IRCCS San Camillo Hospital Foundation
City
Venice
ZIP/Postal Code
30126
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
22261813
Citation
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.
Results Reference
background
PubMed Identifier
23320252
Citation
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.
Results Reference
background
PubMed Identifier
21952215
Citation
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.
Results Reference
background
PubMed Identifier
18156154
Citation
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.
Results Reference
background
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Robotics for Rehabilitation of Hand and Fingers After Stroke
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