Clinical trial NCT05250934: Robotic Telerehabilitation of the Upper Limb in Stroke
Official title: Robotic Telerehabilitation: Feasibility of a Robotic Treatment of the Upper Limb With Remote Supervision in Patients With Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Robotic rehabilitation
Telerehabilitation
Upper extremity
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2022-02-22
Enrollment: 20
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 goal of the study is to investigate the feasibility and the effects of a home-based upper-limb rehabilitation treatment (based on teleconsulting, telemonitoring, and robotic telerehabilitation using the robot Icone and integrated sensors) in patients with stroke.

Detailed description: Stroke is the second leading cause of death, the third leading cause of disability in the world and the leading cause of disability in the elderly. Rehabilitation treatment is a long and costly process, the effectiveness of which is supported by strong scientific evidence. In recent years, technology has spread to the rehabilitation field and, to date, the use of rehabilitation robotics, in addition to conventional treatment, is recommended by some stroke guidelines. The coronavirus pandemic has required a reorganization of rehabilitation services, but also an enhancement of technology as a tool in the rehabilitation field that can allow treatment in compliance with social distancing. Many scientific works have in fact confirmed the usefulness of these approaches to overcome the limits imposed by the pandemic, in particular for the treatment of disabilities in stroke patients.

The rehabilitation robot Icone (CE marked medical device, Class II-A, produced by Heaxel), is a device with certification for home use and therefore suitable for telerehabilitation. The proposed study aims to test the feasibility of rehabilitation treatment in a home setting based on a system of telecounseling, telemonitoring and robotic telerehabilitation using the robot Icone and integrated sensors for patients with stroke, to overcome the limits imposed by the COVID-19 pandemic.

Patients undergo robotic telerehabilitation treatment, carried out at home. The patient is supervised by a caregiver and, remotely, by a multidisciplinary team thanks to the use of webcams and sensors embedded in the robot. The evaluations, through clinical scales and instrumental evaluations, are carried out both in presence (at the enrollment and the end of the study) and remotely (before the first telerobotic rehabilitation session, in the middle and after the last telerobotic rehabilitation session). The study is included in the Regional Smart Specialization Strategy (S3 - Biorobotics for rehabilitation) for business \& life continuity and co-financed by the European Union through LazioInnova

Eligibility criteria: Inclusion Criteria:

* ischemic or hemorrhagic stroke (verified by MRI or CT);
* time since stroke onset \> 3 months
* cognitive abilities adequate to understand the experiments and the follow instructions
* upper limb impairment (Fugl-Meyer Assessment - upper extremity score ≤58);
* presence of a caregiver to supervise the treatment

Exclusion Criteria:

* fixed contractions in the affected limb (ankylosis, Modified Ashworth Scale equal to 4);
* inability to understand the instructions required for the study;
* behavioral disorders that may influence therapeutic activity;
* other orthopedic or neurological diseases
* inability or unwillingness to provide informed consent.

Primary outcomes:
measure: Changes in Fugl-meyer Assessment Upper Extremity motor functioning
timeFrame: Before the intervention, after a 4-week robotic rehabilitation intervention
measure: Reliability of the remote evaluation of the Fugl-meyer Assessment Upper Extremity motor functioning (FMA)
timeFrame: Before the intervention
measure: System Usability Scale
timeFrame: After a 4-week robotic rehabilitation intervention
measure: Technology Acceptance Model (TAM)
timeFrame: After a 4-week robotic rehabilitation intervention
measure: Likert for Satisfaction
timeFrame: After a 4-week robotic rehabilitation intervention
Secondary outcomes:
measure: Changes in Fugl-meyer Assessment Upper Extremity motor functioning
timeFrame: Before the intervention, after a 2-week robotic rehabilitation intervention
measure: Changes in Fugl-meyer Assessment - Sensory functioning
timeFrame: Before the intervention, after a 2-week robotic rehabilitation intervention
measure: Changes in Fugl-meyer Assessment - Sensory functioning
timeFrame: Before the intervention, after a 4-week robotic rehabilitation intervention
measure: Changes in Numeric Rating Scale for pain
timeFrame: Before the intervention, after a 2-week robotic rehabilitation intervention
measure: Changes in Numeric Rating Scale for pain
timeFrame: Before the intervention, after a 4-week robotic rehabilitation intervention
measure: Changes in the Independence Index
timeFrame: Before the intervention, after a 2-week robotic rehabilitation intervention
measure: Changes in the Independence Index
timeFrame: Before the intervention, after a 4-week robotic rehabilitation intervention
measure: Changes in the Area Index [m2]
timeFrame: Before the intervention, after a 2-week robotic rehabilitation intervention
measure: Changes in the Area Index [m2]
timeFrame: Before the intervention, after a 4-week robotic rehabilitation intervention
measure: Changes in the Path Index [mm]
timeFrame: Before the intervention, after a 2-week robotic rehabilitation intervention
measure: Changes in the Path Index [mm]
timeFrame: Before the intervention, after a 4-week robotic rehabilitation intervention
measure: Changes in the Movement Duration index [t]
timeFrame: Before the intervention, after a 2-week robotic rehabilitation intervention
measure: Changes in the Movement Duration index [t]
timeFrame: Before the intervention, after a 4-week robotic rehabilitation intervention
measure: Changes in the Peak speed index [m/s]
timeFrame: Before the intervention, after a 2-week robotic rehabilitation intervention
measure: Changes in the Peak speed index [m/s]
timeFrame: Before the intervention, after a 4-week robotic rehabilitation intervention
measure: Changes in the Mean speed index [m/s]
timeFrame: Before the intervention, after a 2-week robotic rehabilitation intervention
measure: Changes in the Mean speed index [m/s]
timeFrame: Before the intervention, after a 4-week robotic rehabilitation intervention
measure: Changes in the Smoothness index
timeFrame: Before the intervention, after a 2-week robotic rehabilitation intervention
measure: Changes in the Smoothness index
timeFrame: Before the intervention, after a 4-week robotic rehabilitation intervention
measure: Changes in the Hold index [m]
timeFrame: Before the intervention, after a 2-week robotic rehabilitation intervention
measure: Changes in the Hold index [m]
timeFrame: Before the intervention, after a 4-week robotic rehabilitation intervention
measure: Changes in the Displacement index [m]
timeFrame: Before the intervention, after a 2-week robotic rehabilitation intervention
measure: Changes in the Displacement index [m]
timeFrame: Before the intervention, after a 4-week robotic rehabilitation intervention
measure: Reliability of the remote evaluation of the Independence Index
timeFrame: Before the intervention
measure: Reliability of the remote evaluation of the Area Index
timeFrame: Before the intervention
measure: Reliability of the remote evaluation of the Path Index
timeFrame: Before the intervention, after a 4-week robotic rehabilitation intervention
measure: Reliability of the remote evaluation of the Movement Duration index
timeFrame: Before the intervention, after a 4-week robotic rehabilitation intervention
measure: Reliability of the remote evaluation of the Smoothness index
timeFrame: Before the intervention
measure: Reliability of the remote evaluation of the Peak speed index
timeFrame: Before the intervention
measure: Reliability of the remote evaluation of the Mean speed index
timeFrame: Before the intervention
measure: Reliability of the remote evaluation of the Hold index
timeFrame: Before the intervention
measure: Reliability of the remote evaluation of the Displacement index
timeFrame: Before the intervention
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Don Carlo Gnocchi, Santa Maria della Provvidenza Center
Study officials:
affiliation: Fondazione Don Carlo Gnocchi Onlus
name: Irene Aprile, D, PhD
role: PRINCIPAL_INVESTIGATOR
References: