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Upper Limb Robotic Rehabilitation During COVID-19 Outbreak

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Robotic therapy
Sponsored by
Fondazione Don Carlo Gnocchi Onlus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring rehabilitation, stroke, upper extremity, robotics

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Fondazione Don Carlo Gnocchi

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Robotic therapy

Arm Description

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

Outcomes

Primary Outcome Measures

System Usability Scale (SUS)
It is a tool for measuring the usability
Technology Acceptance Model (TAM)
It is a tool for measuring the acceptability.
Likert Scale
It is a tool for measuring the satisfaction.

Secondary Outcome Measures

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.
Motricity Index for the upper extremity (MI-UE)
It is a clinical instrument for characterizing the strength of the paretic upper extremity following stroke.
Modified Ashworth Scale (MAS)
It is a clinical instrument for characterizing upper limb spasticity. Shoulder, elbow and wrist spasticity will be assessed.
Numeric Pain Rating Scale (NPRS)
It is a unidimensional measure of pain intensity in adults.
Modified Barthel Index (mBI)
It is a measure of independence in activities of daily living.
Montreal Cognitive Assessment (MoCA)
It is a widely used screening assessment for detecting cognitive impairment.
Kinematic parameters
The kinematics of the end-effector of the robot will be acquired during point-to-point tasks.

Full Information

First Posted
May 15, 2020
Last Updated
February 18, 2022
Sponsor
Fondazione Don Carlo Gnocchi Onlus
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1. Study Identification

Unique Protocol Identification Number
NCT04392453
Brief Title
Upper Limb Robotic Rehabilitation During COVID-19 Outbreak
Official Title
Upper Limb Robotic Rehabilitation in Stroke Survivors Using a Portable Device During the COVID-19 Outbreak. A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
October 26, 2020 (Actual)
Primary Completion Date
May 18, 2021 (Actual)
Study Completion Date
May 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione Don Carlo Gnocchi Onlus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
rehabilitation, stroke, upper extremity, robotics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Robotic therapy
Arm Type
Experimental
Arm Description
Upper limb robotic rehabilitation by means of the portable robot Icone.
Intervention Type
Device
Intervention Name(s)
Robotic therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
System Usability Scale (SUS)
Description
It is a tool for measuring the usability
Time Frame
After 30 rehabilitation sessions
Title
Technology Acceptance Model (TAM)
Description
It is a tool for measuring the acceptability.
Time Frame
After 30 rehabilitation sessions
Title
Likert Scale
Description
It is a tool for measuring the satisfaction.
Time Frame
After 30 rehabilitation sessions
Secondary Outcome Measure Information:
Title
Fugl-Meyer Assessment for upper extremity (FMA-UE)
Description
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.
Time Frame
At baseline; after 30 rehabilitation sessions
Title
Motricity Index for the upper extremity (MI-UE)
Description
It is a clinical instrument for characterizing the strength of the paretic upper extremity following stroke.
Time Frame
At baseline; after 30 rehabilitation sessions
Title
Modified Ashworth Scale (MAS)
Description
It is a clinical instrument for characterizing upper limb spasticity. Shoulder, elbow and wrist spasticity will be assessed.
Time Frame
At baseline; after 30 session rehabilitation sessions
Title
Numeric Pain Rating Scale (NPRS)
Description
It is a unidimensional measure of pain intensity in adults.
Time Frame
At baseline; after 30 rehabilitation sessions
Title
Modified Barthel Index (mBI)
Description
It is a measure of independence in activities of daily living.
Time Frame
At baseline; after 30 rehabilitation sessions
Title
Montreal Cognitive Assessment (MoCA)
Description
It is a widely used screening assessment for detecting cognitive impairment.
Time Frame
At baseline; after 30 rehabilitation sessions
Title
Kinematic parameters
Description
The kinematics of the end-effector of the robot will be acquired during point-to-point tasks.
Time Frame
At baseline (twice, one day apart); after 10 rehabilitation sessions; after 20 rehabilitation sessions; after 30 rehabilitation sessions

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irene Aprile, MD, PhD
Organizational Affiliation
IRCCS Fondazione Don Carlo Gnocchi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondazione Don Carlo Gnocchi
City
Rome
ZIP/Postal Code
00168
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

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Upper Limb Robotic Rehabilitation During COVID-19 Outbreak

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