Upper Limb Robotic Rehabilitation During COVID-19 Outbreak

Don Carlo Gnocchi Onlus Foundation

Status

Completed

Conditions

Stroke

Treatments

Device: Robotic therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT04392453

FDG_Icone

Details and patient eligibility

About

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.

Full description

This study aims to:

evaluate the feasibility of the bedside use of a novel portable rehabilitation device for upper limb in patients with stroke in an inpatient setting;
assess motor and cognitive outcomes of the treatment;
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.

Enrollment

22 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.