Robotic Telerehabilitation of the Upper Limb in Stroke

NCT05250934 | Completed

• 1 other identifier: FDG-Telerehab2021
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Robotic rehabilitation; Telerehabilitation; Upper extremity

Outcome Measures

Primary Outcomes (5)

• Changes in Fugl-meyer Assessment Upper Extremity motor functioning

  It is a stroke-specific, performance-based impairment index. It ranges from 0 (hemiplegia) to 66 points (normal).

  Before the intervention, after a 4-week robotic rehabilitation intervention

• Reliability of the remote evaluation of the Fugl-meyer Assessment Upper Extremity motor functioning (FMA)

  The value of the FMA obtained by means of online observation of the patient will be assessed in terms of reliability with the value obtained by means of direct observation, using the Intraclass Correlation Coefficient.

  Before the intervention

• System Usability Scale

  It is a self-administered questionnaire to evaluate usability. It ranges from 0 to 100. Higher scores mean better usability.

  After a 4-week robotic rehabilitation intervention

• Technology Acceptance Model (TAM)

  It is a self-administered questionnaire to evaluate the acceptance of the provided intervention. It comprises several questions rated on a 7-point likert scale.

  After a 4-week robotic rehabilitation intervention

• Likert for Satisfaction

  Satisfaction will be assessed using a 11-point likert scale. It ranges from 0 to 10. Higher scores mean higher satisfaction.

  After a 4-week robotic rehabilitation intervention

Secondary Outcomes (32)

• Changes in Fugl-meyer Assessment Upper Extremity motor functioning

  Before the intervention, after a 2-week robotic rehabilitation intervention

• Changes in Fugl-meyer Assessment - Sensory functioning

  Before the intervention, after a 2-week robotic rehabilitation intervention

• Changes in Fugl-meyer Assessment - Sensory functioning

  Before the intervention, after a 4-week robotic rehabilitation intervention

• Changes in Numeric Rating Scale for pain

  Before the intervention, after a 2-week robotic rehabilitation intervention

• Changes in Numeric Rating Scale for pain

  Before the intervention, after a 4-week robotic rehabilitation intervention

Study Arms (1)

Robotic group

EXPERIMENTAL

In the robotic group, each patient undergoes 20 upper limb robotic telerehabilitation sessions, each session lasting 1 hour. The frequency is 5 sessions/week. Each session is performed at the patient's home, with direct supervision of a caregiver and remote supervision of a physical therapist, using three webcams able to show (a) the frontal and (b) the sagittal plane of the patient, as well as (c) the monitor of the robot.

Device: Robotic rehabilitation

Interventions

Robotic rehabilitation DEVICE

The upper limb rehabilitation will be carried out with the planar rehabilitation robot Icone (a CE Class IIA medical device manufactured by Heaxel). The proposed exercises require the patient to move a cursor on the screen using the end-effector of the robot to reach specific points (planar reaching exercises). When the patient is able to perform these exercises independently, the robot assists the movement by minimizing the interaction force applied to the hand and limiting itself to acquiring the kinematic and dynamic parameters of the exercise, which are useful in determining the state of motor skills. Icone assist the subject by applying a force to his hand that helps him complete the task in the phases where the patient plans the movement correctly but is unable to complete it. As a result, the system will enable you to perform planar elbow and shoulder movements in active, passive, or active-assisted modes, with visual and acoustic feedback.

Also known as: Icone (Heaxel)

Robotic group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

Study Sites (1)

Fondazione Don Carlo Gnocchi, Santa Maria della Provvidenza Center

Rome, 00168, Italy

Location

Related Publications (1)

• Germanotta M, Mauro MC, Falchini F, Scotto Di Luzio F, Vollero L, Zollo L, Aprile IG. A robotic rehabilitation intervention in a home setting during the Covid-19 outbreak: a feasibility pilot study in patients with stroke. J Neuroeng Rehabil. 2025 Apr 24;22(1):93. doi: 10.1186/s12984-025-01633-9.

  PMID: 40269913 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Irene Aprile, D, PhD

  Fondazione Don Carlo Gnocchi Onlus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Neurorehabilitation Department, Neurologist, Principal Investigator

Study Record Dates

• First Submitted: February 11, 2022
• First Posted: February 22, 2022
• Study Start: May 12, 2021
• Primary Completion: August 8, 2021
• Study Completion: August 8, 2021
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

IT (1)