Clinical trial NCT05288270: ROBOtic Care of Post-stroke Pain.
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Robotic rehabilitation
Pain
stroke recovery
Lead sponsor: S.Anna Rehabilitation Institute
Sponsor class: OTHER
First posted: 2022-03-21
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fugl-Meyer Motor Assessment - upper extremity (FMA-UE)
timeFrame: up to 6 months after the admission assessment.
measure: Action Research Arm Test (ARAT)- Motor recovery scale
timeFrame: up to 6 months after the admission assessment.
measure: Visual Analogue Scale (VAS) - Pain reduction
timeFrame: up to 6 months after the admission assessment.
measure: Barthel Index (BI)
timeFrame: up to 6 months after the admission assessment.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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