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AI-based Upper Limb Rehabilitation Therapy With MOTORE (iMotore)

D

Don Carlo Gnocchi Onlus Foundation

Status

Completed

Conditions

Stroke

Treatments

Device: AI-based upper limb robotic therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT05238389
FDG-iMotore

Details and patient eligibility

About

Stroke is a common disease with a high disabling impact; it is the world's second leading cause of death and the third leading cause of disability. Robotic therapy has been proposed as a viable approach for the rehabilitation of the upper limb, as a way to increase the amount and the intensity of the therapy, and to standardize the treatment. However, robotic technologies have not yet been used to their full potential in terms of tailoring rehabilitation paths and monitoring the response to treatments. The main goal of the study is to use AI algorithms to (a) predict the recovery of the patients and (b) suggest exercises and parameters to improve the outcomes of the treatment.

Enrollment

44 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • first ischemic or hemorrhagic stroke (verified by MRI or CT);
  • time since stroke onset between 1 and 6 months (subacute phase)
  • cognitive abilities adequate to understand the experiments and the follow instructions
  • upper limb impairment (Fugl-Meyer Assessment - Upper Extremity score ≤58);

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

44 participants in 1 patient group

Robotic group
Experimental group
Description:
In the robotic group, patients will undergo a 30-session upper limb robotic rehabilitation using the device MOTORE.
Treatment:
Device: AI-based upper limb robotic therapy

Trial contacts and locations

1

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Central trial contact

Irene Aprile, MD, PhD

Data sourced from clinicaltrials.gov

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