ROBOtic Care of Post-stroke Pain.

Study Overview
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Brief Summary
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In agreement to the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) recommendations that support the importance of physical functioning as core outcome for pain this randomized, double-blind, controlled clinical trial will be the pilot forming the rational basis for the assessment of the efficacy in the use of Robotic rehabilitation system to prevent chronic post stroke pain development. In fact, according to working hypothesis, proprioceptive inputs with high-intensive bilateral movement training of the hemiplegic arm can improve recovery and plasticity, thus preventing chronic post-stroke pain from occurring within the 3-6 months following stroke.

Detailed Description
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Stroke is one of the most frequent causes of death and disability worldwide. It is accompanied by impaired motor function of the upper extremities in over 69% of patients up to hemiplegia in the following 5 years in 56% of cases. This condition often is characterized by chronic post-stroke pain, difficult to manage and further worsening the patients' quality of life. Post-stroke pain occurs within 3-6 months and aberrant neuroplasticity in the first 3-4 weeks is implicated in its development. Robot-assisted neurorehabilitation using the Automatic Recovery Arm Motility Integrated System (ARAMIS) has proven efficacy in motor function recovery exploiting the movements and the strength of the unaffected arm to drive correct brain re-arrangement. Therefore, the rationale of the ROBOCOP (ROBOtic Care of Post-stroke pain) randomized, double-blind trial for the assessment of the impact of robot-assisted functional and motor recovery on post-stroke pain development is based on the prevention of anomalous plasticity and, hopefully, on the recovery of connectivity in the injured area. To this aim, a total of 118 patients with hemiplegic arm due to stroke will be enrolled and randomly allocated with 1:1 ratio to ARAMIS or conventional neurorehabilitation group. After a baseline screening at hospital discharge during subacute period, ARAMIS or conventional rehabilitation will be performed for 8 weeks. The primary endpoint will consist in improvement of the Upper Extremity Subscale of the Fugl-Meyer Motor Assessment (FMA-UE), for the body functions of the upper extremity section domain; the Action Research Arm Test (ARAT) scores at 1, 2, 3 and 6 months after stroke. The secondary endpoints include no worsening of pain Visual Analogue Scale (VAS) and improvement of Barthel Index (BI) for activities of daily living and of Frenchay activities index (FAI) for physical activity, as well as improvement of magnetic resonance imaging (MRI) and electroencephalographic (EEG) parameters This is the first clinical trial investigating the efficacy of robot-assisted neurorehabilitation using ARAMIS on brain plasticity and re-organization and on post-stroke pain prevention. This study could remarkably improve the quality of life of stroke survivors.

Official Title
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ROBOCOP (ROBOtic Care of Post-stroke Pain): Study Protocol for a Randomized, Double-blind Trial to Assess Robot-assisted Functional and Motor Recovery and Impact on Post-stroke Pain Development

Conditions
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Stroke

Intervention / Treatment
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* Device: Aramis
* Other: Conventional therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stroke-related hemiplegic arm; Hemiplegic subacute patients of any age at hospital discharge after stroke with functional magnetic resonance imaging (fMRI) scan of the area affected. Exclusion Criteria: Bilateral impairment; Presence of aphasia; Presence of cognitive impairment; Stroke diagnosis without occurrence of hemiparesis of the upper limb.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This randomized, double-blind, single center trial will recruit subacute hemiplegic patients of any age with hemiparesis of the arm after stroke. The trial is designed as prospective, exploratory, interventional study without drug. The study does not request the use of drugs. This study protocol follows the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Checklist.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aramis Group<br>Consecutive patients, admitted to Sant' Anna Institute with diagnosis of stroke after hospital discharge that need motor and cognitive treatment and rehabilitation of neurological diseases. | Device: Aramis<br>* ARAMIS is composed of two computer-controlled, symmetric and interacting exoskeletons able to compensate the inadequate strength and accuracy of the paretic arm movements, of which it measures residual motor function, and the effect of gravity during rehabilitation. It acts through motion capture of the movements of the unaffected arm. In so doing, the patient is able to replicate the movements of the healthy arm with the paretic arm in synchronous, asynchronous or active-assisted manner. The robot-assisted neurorehabilitation using ARAMIS consists in 60-min sessions for 8 weeks,structured as follows: 1 to 4 weeks: asynchronous exercises of repletion by the paretic arm of basic exercises 20 times for a total of 200 repetitions per session; 5 to 8 weeks: replaced by synchronous exercises (100/session) with active-assisted modality.<br>|
| Active Comparator: Conventional Group therapy<br>Consecutive patients, admitted to Sant' Anna Institute with diagnosis of stroke after hospital discharge that need motor and cognitive treatment and rehabilitation of neurological diseases. | Other: Conventional therapy<br>* The control group will receive conventional rehabilitation consisting in passive mobilization of upper and lower limbs, coordination respiratory exercises, cardiovascular conditioning in the setting posture, conditioning in the upright posture, exercises for the trunk control.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Motor Assessment - upper extremity (FMA-UE) | Improvement of Fugl-Meyer Motor Assessment (FMA-UE) scores. The score may range from 0 to 115. A higher score indicates better recovery | up to 6 months after the admission assessment. | 
| Action Research Arm Test (ARAT)- Motor recovery scale | Improvement of Action Research Arm Test (ARAT) scores. Scores on the ARAT may range from 0-57 points, with a maximum score of 57 points indicating better performance | up to 6 months after the admission assessment. | 
| Visual Analogue Scale (VAS) - Pain reduction | No worsening of Visual Analogue Scale (VAS). Using a ruler, the score is determined by mea-suring the distance (mm) on the 10-cm line between the no pain anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in patients who described their pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm). | up to 6 months after the admission assessment. | 
| Barthel Index (BI) | Improvement of Barthel Index (BI). Scores on the BI may range from 0-100 points, with a maximum score of 100 points. Score from 80 to 100 indicates that the patient should be able to live indipendently | up to 6 months after the admission assessment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Robotic rehabilitation, Pain, stroke recovery