Upper Limb Robotic Rehabilitation During COVID-19 Outbreak

NCT ID: NCT04392453

Last Updated: 2022-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-26
• Study Completion Date: 2021-05-18

Brief Summary

The COVID-19 outbreak requires a rapid re-shaping of the entire organization of the rehabilitation services. This includes the design and planning of appropriate rehabilitation settings, intervention and logistics for organizing space for patients.

The aims of this study are: (a) to evaluate the feasibility of the bedside use of a novel rehabilitation device for upper limb in patients with stroke; (b) to evaluate the motor and cognitive outcomes of the treatment; (c) to validate the instrumental outcomes provided by the device.

Detailed Description

This study aims to:

1. evaluate the feasibility of the bedside use of a novel portable rehabilitation device for upper limb in patients with stroke in an inpatient setting;

2. assess motor and cognitive outcomes of the treatment;

3. validate the instrumental outcomes provided by the device.

Forty subacute stroke patients with upper limb hemiplegia will be enrolled. Patients' upper limb will be treated with a novel portable robotic device (Icone, Heaxel). The robot will be transferred to each patient's room, where the rehabilitation session will be performed, thanks to the portability of the device. During the treatment, patients will execute "exergames" involving elbow flexion-extension, shoulder protraction-retraction, internal-external rotation, flexion-extension and abduction-adduction. The exercises will be selected among the available ones to train both motor and cognitive functions. The rehabilitation intervention will include 30 rehabilitation sessions, each lasting 45 minutes, three to five times a week. In addition to the upper limb treatment, patients will receive a rehabilitation treatment for the lower limbs.

For Aim 1, the usability and the acceptability of the device and the satisfaction with the treatment will be evaluated at the end of the rehabilitation intervention by means of the System Usability Scale (SUS), the Technology Acceptance Model (TAM), and the Likert scale, respectively.

For Aim 2, the clinical effect of the treatment with the robot will be investigated by means of the following scales, assessed both at baseline and at discharge: the Fugl-Meyer Assessment for the upper extremity (FMA-UE), the Motricity Index (MI), the Modified Ashworth Scale (MAS), the Modified Barthel Index (mBI), the Numeric Pain Rating Scale (NPRS), and the Montreal Cognitive Assessment (MoCA)

For Aim 3, at baseline, each patient will perform the kinematic and kinetic assessment provided by the robot twice, one day apart, to assess the reliability of the kinematic parameters provided by the robot; moreover, the kinematic and kinetics assessment will be performed every ten rehabilitation sessions, to analyze the responsiveness of the kinematic parameters and possible "plateau" in the recovery process.

Conditions

Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Robotic therapy

Upper limb robotic rehabilitation by means of the portable robot Icone.

Group Type: EXPERIMENTAL

Robotic therapy

Intervention Type: DEVICE

The treatment with the robot Icone will include 30 sessions, each session lasting 45 minutes, with a frequency from three to five times a week. The treatment will be provided in the patient's room. Patients will execute upper limb movement involving elbow flexion-extension, shoulder protraction-retraction, internal-external rotation, flexion-extension, and abduction-adduction. Visual and auditory feedback will be provided during the tasks. The exercises will train both motor and cognitive functions.

Interventions

Robotic therapy

The treatment with the robot Icone will include 30 sessions, each session lasting 45 minutes, with a frequency from three to five times a week. The treatment will be provided in the patient's room. Patients will execute upper limb movement involving elbow flexion-extension, shoulder protraction-retraction, internal-external rotation, flexion-extension, and abduction-adduction. Visual and auditory feedback will be provided during the tasks. The exercises will train both motor and cognitive functions.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• first ischemic or hemorrhagic stroke (verified by MRI or CT);
• time latency within 6 months from stroke (subacute patients);
• age between 35-85 years;
• cognitive abilities adequate to understand the experiments and the follow instructions
• upper limb impairment (FMA-UE score ≤58);
• ability to give written consent;
• compliance with the study procedures.

Exclusion Criteria

• history of recurrent stroke;
• inability to understand the instructions required for the study;
• fixed contractions in the affected limb (ankylosis, Modified Ashworth Scale equal to 4);
• severe deficits in visual acuity.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Don Carlo Gnocchi Onlus

OTHER

Sponsor Role: lead

Responsible Party

Irene Giovanna Aprile

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Irene Aprile, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Fondazione Don Carlo Gnocchi

Locations

Fondazione Don Carlo Gnocchi

Rome, , Italy

Countries

Italy

Other Identifiers

FDG_Icone

Identifier Type: -

Identifier Source: org_study_id