Robotics for Rehabilitation of Hand and Fingers After Stroke (sERF)

IRCCS San Camillo, Venezia, Italy

Status

Completed

Conditions

Stroke

Treatments

Device: AMADEO

Study type

Interventional

Funder types

Other

Identifiers

NCT03207490

Prot. 2014.14

Details and patient eligibility

About

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).

Full 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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).