Myoelectric Robot-assisted Rehabilitation for the Upper Limb After Stroke

Study Overview
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Brief Summary
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The aim of this study is to assess the clinical effectiveness of the RehaARM-robot and to determine the feasibility of including robotic therapy in daily rehabilitation programmes, after stroke. Additionally, we aim to investigate the acceptance of this intervention from patients and therapists. A total of 10 patients will be recruited in this study, all the patients will receive 1 hour of standard therapy together with 45 min of robot therapy every day. The robot therapy will last 45 minutes, for 15 consecutive days within a maximum period of four weeks. Additional 15 minutes are required for placing surface electrodes on the shoulder and patient preparation. The study will include passive and active shoulder training of four movements: Horizontal abduction/adduction, abduction/adduction, internal/external rotation and flexion/extension. The passive part lasts 10 minutes and the active part 35 minutes.

Official Title
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A Pilot Study of Active, Robot-assisted Therapy for Shoulder Rehabilitation After Stroke, Using Myoelectric Signals

Conditions
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Stroke

Intervention / Treatment
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* Device: The RehaARM-Robot
* Behavioral: Standard rehabilitation therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients suffering from stroke, ischemic and / or hemorrhagic Stroke in the left hemisphere Score between 1 and 3 in the upper-limb sub-item of the Italian version of the National Institute of Health Stroke Scale (IT-NIHSS) (Pezzella et al. 2009) Score of the Functional Independence Measure (FIM) scale (Keith et al., 1987) less than 100 out of a total of 126. This scale is used as a reference to indicate the degree of autonomy in carrying out activities of daily living (ADLs) Score of the upper-limb Fugl-Meyer scale (FMA) (Fugl-Meyer et al., 1975) less than 60. This scale measures the residual motor function of a person after stroke Exclusion Criteria: Non-stabilized fractures Diagnosis of depression Traumatic brain Injury Pharmacologically uncontrolled epilepsy Ideomotor apraxia Neglect Mini Mental State Examination (MMSE) score <20/30 Severe impairment of verbal comprehension, defined by a score in the Token Test (Tau points<58/78) Patients participating in other rehabilitation treatments for the upper-limb (e.g. virtual reality treatment, motor imagery, etc)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The RehaARM-Robot<br>Receive 45 min of robot-assisted therapy for the shoulder and 1 hour of daily standard rehabilitation therapy. | Device: The RehaARM-Robot<br>* Robot therapy by using a 3-Degrees-Of-Freedom (3DOFs) robot to train the shoulder.<br>* Other names: Robot-assisted therapy for the shoulder;Behavioral: Standard rehabilitation therapy<br>* Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Assessment scale - Upper Extremity (FMA-UE) | Motor function of the upper limb is measured by means of the Upper Extremity Motor Assessment of the Fugl-Meyer Assessment Scale. | 3 weeks (15 sessions) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Independence Measure (FIM) | FIM is an 18-item scale that assesses patient's disability and medical rehabilitation functional outcome (A total of 126 points). | 3 weeks (15 sessions) | 
| Reaching Performance Scale (RPS) | It assesses the ability of subjects to reach an object (a cone). The cone is placed at a 4-cm distance and after at a 30-cm 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 ( A total of 36 points). | 3 weeks (15 sessions) | 
| Modified Ashworth Scale (MAS) of five muscles | Spasticity is measured using the MAS of five muscles: Pectoralis major, biceps, wrist flexors, flexor digitorum superficialis, flexor digitorum profundus (Total of 20 points). | 3 weeks (15 sessions) | 
| Nine Hole Pegboard Test (NHPT) | It 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 min are registered or if the patient inserted 9 pins, then the time is registered. | 3 weeks (15 sessions) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Upper limb, Robotics, Electromyography, Rehabilitation