NCT06795672

Brief Summary

The aim of the study is to evaluate whether a computer-based cognitive treatment delivered via tele-rehabilitation produces an improvement in cognitive functioning comparable to the improvement achievable through the same treatment delivered in person in patients with stroke outcomes. To investigate, using a custom-designed questionnaire, the feasibility and patient satisfaction with the rehabilitative treatment delivered via telemedicine compared to the same treatment delivered in person.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 28, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 28, 2025

Completed
Last Updated

January 28, 2025

Status Verified

March 1, 2022

Enrollment Period

2 years

First QC Date

January 21, 2025

Last Update Submit

January 21, 2025

Conditions

RehabilitationStrokeTelerehabilitationTelemedicine

Keywords

stroketelemedicinerehabilitation

Outcome Measures

Primary Outcomes (1)

  • Trail Making Test Part B (TMT-B)

    Used as a measure of attentional set-shifting and mental flexibility. Time needed to complete the tasks is recorded.

    From enrollment to the end of treatment and 2 months until the end of treatment

Secondary Outcomes (10)

  • The Trail Making Test - A (TMT-A)

    From enrollment to the end of treatment and 2 months until the end of treatment

  • 15 Words of Rey

    From enrollment to the end of treatment and 2 months until the end of treatment

  • Memory with interference - ENB 2

    From enrollment to the end of treatment and 2 months until the end of treatment

  • Dual task test

    From enrollment to the end of treatment and 2 months until the end of treatment

  • Elithorn's Perceptual Maze Test

    From enrollment to the end of treatment and 2 months until the end of treatment

  • +5 more secondary outcomes

Study Arms (2)

Telerehabilitation group

EXPERIMENTAL

Three hours of cognitive rehabilitation per week, performed remotely and independently, using a computerized device, which is pre-programmed based on the patient's needs.

Behavioral: Telerehabilitation

In-person treatment

ACTIVE COMPARATOR

Three hours of in-person cognitive rehabilitation per week using a computerized device.

Behavioral: Traditional in-person rehabilitation.

Interventions

TelerehabilitationBEHAVIORAL

Three hours of cognitive rehabilitation per week, performed remotely and independently, using a computerized device, which is pre-programmed based on the patient's needs.

Telerehabilitation group
Traditional in-person rehabilitation.BEHAVIORAL

Three hours of in-person cognitive rehabilitation per week using a computerized device.

In-person treatment

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of ischemic or hemorrhagic stroke;
  • Age between 18 and 90 years;
  • First stroke event;
  • Stroke occurred more than 30 days ago;
  • Adequate level of understanding;
  • Presence of one or more of the following cognitive disorders:
  • Memory disorders
  • Attention disorders
  • Executive function disorders
  • Availability of an internet connection at the patient's home necessary for the telemedicine procedures.

You may not qualify if:

  • Presence of other neurological disorders;
  • Presence of pre-morbid cognitive decline;
  • Psychiatric disorders in the medical history;
  • Alcohol and/or drug abuse;
  • Presence of severe uncorrected visual deficits.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sezione medicina fisica e riabilitativa dipartimento di neuroscienze

Verona, verona, Italy

Location

MeSH Terms

Conditions

Stroke

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesTelemedicineDelivery of Health CarePatient Care ManagementHealth Services Administration

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

January 21, 2025

First Posted

January 28, 2025

Study Start

March 28, 2022

Primary Completion

March 31, 2024

Study Completion

March 31, 2024

Last Updated

January 28, 2025

Record last verified: 2022-03

Locations

IT(1)