Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
NCT06109324

Sensory and Cognitive Outcomes of Robotic Exercises in Stroke (SCORES)

Led by Fondazione Don Carlo Gnocchi Onlus · Updated on 2024-10-15

126

Participants Needed

3

Research Sites

111 weeks

Total Duration

On this page

Sponsors

F

Fondazione Don Carlo Gnocchi Onlus

Lead Sponsor

I

IRCCS Centro Neurolesi Bonino Pulejo

Collaborating Sponsor

AI-Summary

What this Trial Is About

Based on the findings of meta-analyses, upper limb robotic rehabilitation has shown to enhance daily living activities, motor function, and strength in stroke patients. However, when compared to traditional methods, recent randomized controlled trials conducted on larger participant groups failed to identify significant differences in motor-related outcomes between the two approaches. In addition to motor deficits, stroke survivors often experience cognitive decline and sensory disturbances, which can significantly impede their recovery process. The introduction of multisensory stimulation and an enriched environment through robotic interventions may offer valuable supplementary treatments in these specific areas. Nevertheless, this aspect of treatment has not been thoroughly explored. This study seeks to assess the effectiveness of upper limb robotic rehabilitation in individuals recovering from subacute strokes, in comparison to conventional treatments. Specifically, it aims to determine whether this robotic therapy can lead to improvements in (a) cognitive deficits, (b) somatosensory impairment, and (c) how these sensory and cognitive deficits influence the process of motor recovery.

CONDITIONS

Official Title

Sensory and Cognitive Outcomes of Robotic Exercises in Stroke (SCORES)

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • A single stroke event confirmed by MRI or CT scan
  • Age between 18 and 85 years
  • Stroke occurred within the past six months
  • Montreal Cognitive Assessment (MoCA) score between 15.5 and 22.23, adjusted for demographics
Not Eligible

You will not qualify if you...

  • Behavioral or cognitive disorders or reduced compliance interfering with active therapy
  • Fixed contraction deformity in the affected limb (e.g., ankylosis, Modified Ashworth Scale = 4) interfering with active therapy
  • Severe visual acuity deficits

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

IRCCS Fondazione Don Carlo Gnocchi

Florence, Italy, 50143

Actively Recruiting

2

IRCCS Centro Neurolesi Bonino Pulejo

Messina, Italy, 98123

Actively Recruiting

3

Fondazione Don Carlo Gnocchi - Centro Santa Maria della Provvidenza

Roma, Italy, 00166

Actively Recruiting

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Research Team

M

Marco Germanotta, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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