Clinical trial NCT04392453: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: rehabilitation
stroke
upper extremity
robotics
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2020-05-18
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: System Usability Scale (SUS)
timeFrame: After 30 rehabilitation sessions
measure: Technology Acceptance Model (TAM)
timeFrame: After 30 rehabilitation sessions
measure: Likert Scale
timeFrame: After 30 rehabilitation sessions
Secondary outcomes:
measure: Fugl-Meyer Assessment for upper extremity (FMA-UE)
timeFrame: At baseline; after 30 rehabilitation sessions
measure: Motricity Index for the upper extremity (MI-UE)
timeFrame: At baseline; after 30 rehabilitation sessions
measure: Modified Ashworth Scale (MAS)
timeFrame: At baseline; after 30 session rehabilitation sessions
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: At baseline; after 30 rehabilitation sessions
measure: Modified Barthel Index (mBI)
timeFrame: At baseline; after 30 rehabilitation sessions
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: At baseline; after 30 rehabilitation sessions
measure: Kinematic parameters
timeFrame: At baseline (twice, one day apart); after 10 rehabilitation sessions; after 20 rehabilitation sessions; after 30 rehabilitation sessions
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Don Carlo Gnocchi
Study officials:
affiliation: IRCCS Fondazione Don Carlo Gnocchi
name: Irene Aprile, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: