ROBOtic Care of Post-stroke Pain. (Robocop)

S.Anna Rehabilitation Institute

Status: Unknown

Conditions: Stroke

Treatments: Other: Conventional therapy; Device: Aramis

Study type: Interventional

Funder types: Other

Identifiers

NCT05288270

ISA-ROBOCOP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 118 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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118 participants in 2 patient groups

Aramis Group

Experimental group

Description:

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.

Treatment:

Device: Aramis

Conventional Group therapy

Active Comparator group

Description:

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.

Treatment:

Other: Conventional therapy