ROBOtic Care of Post-stroke Pain. (Robocop)

March 10, 2022 updated by: S.Anna Rehabilitation Institute

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

118

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aramis Group
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

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.
Active Comparator: Conventional Group therapy
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl-Meyer Motor Assessment - upper extremity (FMA-UE)
Time Frame: up to 6 months after the admission assessment.
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
Time Frame: up to 6 months after the admission assessment.
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
Time Frame: up to 6 months after the admission assessment.
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)
Time Frame: up to 6 months after the admission assessment.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

S.Anna Rehabilitation Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2022

Primary Completion (Anticipated)

July 30, 2022

Study Completion (Anticipated)

July 30, 2023

Study Registration Dates

First Submitted

November 10, 2021

First Submitted That Met QC Criteria

March 10, 2022

First Posted (Actual)

March 21, 2022

Study Record Updates

Last Update Posted (Actual)

March 21, 2022

Last Update Submitted That Met QC Criteria

March 10, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISA-ROBOCOP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

De-identified individual partecipant data for all primary and secondary outcome measures will be made available.

IPD Sharing Time Frame

1 year after the end of the study

IPD Sharing Access Criteria

Data access request will be reviewed by an internal audit committee in conjunction with a panel of university experts

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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