Upper Limb Robotic Rehabilitation During COVID-19 Outbreak

Stroke Clinical Trial

Official title:

Upper Limb Robotic Rehabilitation in Stroke Survivors Using a Portable Device During the COVID-19 Outbreak. A Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04392453
• Other study ID #: FDG_Icone
• Status: Completed
• Phase: N/A
• Start date: October 26, 2020
• Est. completion date: May 18, 2021

Study information

• Verified date: February 2022
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: May 18, 2021
• Est. primary completion date: May 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Italy	Fondazione Don Carlo Gnocchi	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	System Usability Scale (SUS)	It is a tool for measuring the usability	After 30 rehabilitation sessions
Primary	Technology Acceptance Model (TAM)	It is a tool for measuring the acceptability.	After 30 rehabilitation sessions
Primary	Likert Scale	It is a tool for measuring the satisfaction.	After 30 rehabilitation sessions
Secondary	Fugl-Meyer Assessment for upper extremity (FMA-UE)	The Fugl-Meyer Assessment is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment.	At baseline; after 30 rehabilitation sessions
Secondary	Motricity Index for the upper extremity (MI-UE)	It is a clinical instrument for characterizing the strength of the paretic upper extremity following stroke.	At baseline; after 30 rehabilitation sessions
Secondary	Modified Ashworth Scale (MAS)	It is a clinical instrument for characterizing upper limb spasticity. Shoulder, elbow and wrist spasticity will be assessed.	At baseline; after 30 session rehabilitation sessions
Secondary	Numeric Pain Rating Scale (NPRS)	It is a unidimensional measure of pain intensity in adults.	At baseline; after 30 rehabilitation sessions
Secondary	Modified Barthel Index (mBI)	It is a measure of independence in activities of daily living.	At baseline; after 30 rehabilitation sessions
Secondary	Montreal Cognitive Assessment (MoCA)	It is a widely used screening assessment for detecting cognitive impairment.	At baseline; after 30 rehabilitation sessions
Secondary	Kinematic parameters	The kinematics of the end-effector of the robot will be acquired during point-to-point tasks.	At baseline (twice, one day apart); after 10 rehabilitation sessions; after 20 rehabilitation sessions; after 30 rehabilitation sessions