NCT04392453

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 18, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

October 26, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2021

Completed
Last Updated

February 21, 2022

Status Verified

February 1, 2022

Enrollment Period

7 months

First QC Date

May 15, 2020

Last Update Submit

February 18, 2022

Conditions

Stroke

Keywords

rehabilitationstrokeupper extremityrobotics

Outcome Measures

Primary Outcomes (3)

  • System Usability Scale (SUS)

    It is a tool for measuring the usability

    After 30 rehabilitation sessions

  • Technology Acceptance Model (TAM)

    It is a tool for measuring the acceptability.

    After 30 rehabilitation sessions

  • Likert Scale

    It is a tool for measuring the satisfaction.

    After 30 rehabilitation sessions

Secondary Outcomes (7)

  • Fugl-Meyer Assessment for upper extremity (FMA-UE)

    At baseline; after 30 rehabilitation sessions

  • Motricity Index for the upper extremity (MI-UE)

    At baseline; after 30 rehabilitation sessions

  • Modified Ashworth Scale (MAS)

    At baseline; after 30 session rehabilitation sessions

  • Numeric Pain Rating Scale (NPRS)

    At baseline; after 30 rehabilitation sessions

  • Modified Barthel Index (mBI)

    At baseline; after 30 rehabilitation sessions

  • +2 more secondary outcomes

Study Arms (1)

Robotic therapy

EXPERIMENTAL

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

Device: Robotic therapy

Interventions

Robotic therapyDEVICE

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.

Robotic therapy

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Don Carlo Gnocchi

Rome, 00168, Italy

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Irene Aprile, MD, PhD

    IRCCS Fondazione Don Carlo Gnocchi

    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
MD, PhD

Study Record Dates

First Submitted

May 15, 2020

First Posted

May 18, 2020

Study Start

October 26, 2020

Primary Completion

May 18, 2021

Study Completion

May 18, 2021

Last Updated

February 21, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)