NCT05788133

Brief Summary

The role of humanoid robot in neuropsychological assessment and conducting cognitive training in patients with dementia and severe brain injury" Objectives Use of robotic solutions to carry out diagnostic and rehabilitation intervention in order to recover cognitive and relational performance of patients with dementia and severe brain injury. Study Design. Observational Materials and Methods. Eighty subjects (25 with mild-moderate dementia and 25 patients with severe brain injury) will be enrolled. Patients will undergo neurological examination with collection of all medical history and information on current clinical condition. After that, they will undergo administration of neuropsychological tests via humanoid robot and two months of cognitive rehabilitation sessions. Inclusion criteria

  • Over 18 years of age;
  • Patients with a moderately impaired cognitive profile;
  • Written consent from the legal guardian or the patient himself/herself. Exclusion criteria.
  • Patients with language comprehension deficits;
  • Patients with disorders of consciousness;
  • Patients who are unable to provide a localized, context-appropriate response; and All eligible patients will undergo cognitive assessment using the robot at the time of enrollment (T0), and after 2 months of rehabilitation treatment (T1) Translated with www.DeepL.com/Translator (free version)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

September 28, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 28, 2023

Completed
Last Updated

March 28, 2023

Status Verified

September 1, 2022

Enrollment Period

3 months

First QC Date

March 14, 2023

Last Update Submit

March 27, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • mini mental state examination (MMSE)

    administration MMSE with humanoid robot

    2 months

Study Arms (1)

treatment

EXPERIMENTAL

administration neuropsychological tests with pepper

Other: treatment and screening by neuropsychological tests on humanoid robot

Interventions

treatment and screening by neuropsychological tests on humanoid robot

treatment

Eligibility Criteria

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

You may qualify if:

  • Over 18 years old;
  • Patients with moderately impaired cognitive profile;
  • Written consent from the legal guardian or the patient himself

You may not qualify if:

  • Patients with language comprehension deficit;
  • Patients with disorders of consciousness;
  • Patients who are unable to provide a localized and context-appropriate response

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Centro Neurolesi "Bonino-Pulejo"

Messina, 98124, Italy

Location

MeSH Terms

Conditions

Neurodegenerative DiseasesStroke

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Nervous System DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • silvia marino, MD

    IRCCS Centro Neurolesi Bonino Pulejo

    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
Neurologist

Study Record Dates

First Submitted

March 14, 2023

First Posted

March 28, 2023

Study Start

September 28, 2022

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

March 28, 2023

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

corresponding author

Locations