Robotics for Rehabilitation of Hand and Fingers After Stroke

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2017-12-31

Brief Summary

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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).

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Detailed Description

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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

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Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Intervention is provided by a robotic device for hand motion, controlled by closed loop surface electromyography (sEMG)

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Robot group

Receive 1 hour of AMADEO (robot-assisted therapy) for the hand and 1 hour of daily standard rehabilitation therapy

Group Type EXPERIMENTAL

AMADEO

Intervention Type DEVICE

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

Interventions

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AMADEO

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

Intervention Type DEVICE

Other Intervention Names

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Robot-assisted therapy for the hand

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No