Clinical trial NCT03207490: Robotics for Rehabilitation of Hand and Fingers After Stroke
Official title: sEMG Based-Rehabilitation of Hand and Fingers After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Hand
Rehabilitation
sEMG
Lead sponsor: IRCCS San Camillo, Venezia, Italy
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Intervention is provided by a robotic device for hand motion, controlled by closed loop surface electromyography (sEMG)
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Change at Box and Block Test (BBT)
timeFrame: Before treatment, then 3 weeks after
Secondary outcomes:
measure: Change at Functional Independence Measure scale (FIM)
timeFrame: Before treatment, then 3 weeks after
measure: Change at Reaching Performance Scale (RPS)
timeFrame: Before treatment, then 3 weeks after
measure: Change at Modified Ashworth Scale (MAS)
timeFrame: Before treatment, then 3 weeks after
measure: Change at Nine Hole Pegboard Test (NHPT)
timeFrame: Before treatment, then 3 weeks after
measure: Change at Fugl-Meyer Assessment Scale: Upper Extremity Motor Function (F-M UE)
timeFrame: Before treatment, then 3 weeks after
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Tyromotion GmbH
city: Venice
country: Italy
facility: IRCCS San Camillo Hospital Foundation
Study officials:
affiliation: IRCCS San Camillo, Venezia, Italy
name: Andrea Turolla, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.