Robotics for Rehabilitation of Hand and Fingers After Stroke

Study Overview
=================
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.

Official Title
-----------------
sEMG Based-Rehabilitation of Hand and Fingers After Stroke

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Device: AMADEO


Participation Criteria
=================
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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Intervention is provided by a robotic device for hand motion, controlled by closed loop surface electromyography (sEMG)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robot group<br>Receive 1 hour of AMADEO (robot-assisted therapy) for the hand and 1 hour of daily standard rehabilitation therapy | Device: AMADEO<br>* 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<br>* Other names: Robot-assisted therapy for the hand;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Before treatment, then 3 weeks after | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Before treatment, then 3 weeks after | 
| 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). | Before treatment, then 3 weeks after | 
| 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). | Before treatment, then 3 weeks after | 
| 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. | Before treatment, then 3 weeks after | 
| 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) | Before treatment, then 3 weeks after | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hand, Rehabilitation, sEMG