Teleneurorehabilitation for the Continuity of Care Post-stroke: a Multicentric Pilot Study

NCT ID: NCT05703906

Last Updated: 2023-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-16

Study Completion Date

2021-12-31

Brief Summary

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The main aim of this longitudinal, pilot study is to evaluate the feasibility of a multi-domain (i.e., motor, language and cognitive domains) telerehabilitation system using the Virtual Reality Rehabilitation System (VRRS, Khymeia) in patients with stroke. Furthermore, data on patients' needs and clinical data will be collected before and after treatment and then analyzed.

Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Telerehabilitation

All patients will receive a kit home-based consisting of a tablet home, an exercise equipment and access to a daily individualized training program based on their needs (i.e., motor, language and/or cognitive training programs).

The exercise program and patients' sessions will be remotely supervised by therapists.

Group Type EXPERIMENTAL

Telerehabilitation - VRRS Khymeia

Intervention Type BEHAVIORAL

Participants will receive an individualized, multidomain exercise program set up by the therapist, based on their needs. The intervention applied will consist of 20 sessions of motor, language and/or cognitive training distributed in five sessions for week, each lasting 1 hour. Remotely, the therapist will supervise the participant's exercise program.

Interventions

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Telerehabilitation - VRRS Khymeia

Participants will receive an individualized, multidomain exercise program set up by the therapist, based on their needs. The intervention applied will consist of 20 sessions of motor, language and/or cognitive training distributed in five sessions for week, each lasting 1 hour. Remotely, the therapist will supervise the participant's exercise program.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Single ischemic stroke documented by CT/ MRI;
* 2 to 18 months after the event.

Exclusion Criteria

* medical history or presence of cognitive decline (MoCA\<17.54)
* recent fractures
* History of mental disorders (major depression, psychosis)
* History/presence of other neurological disorders that may interfere with outcome
* Presence of other internal pathologies that may interfere with outcome or treatment
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Centro Neurolesi Bonino Pulejo

OTHER

Sponsor Role collaborator

Fondazione Don Carlo Gnocchi Onlus

OTHER

Sponsor Role collaborator

Fondazione Mondino

OTHER

Sponsor Role collaborator

IRCCS San Raffaele Roma

OTHER

Sponsor Role collaborator

Istituto Clinico Humanitas

OTHER

Sponsor Role collaborator

IRCCS San Camillo, Venezia, Italy

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luisa Cacciante, MSc

Role: PRINCIPAL_INVESTIGATOR

IRCCS San Camillo Hospital

Locations

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IRCCS San Camillo Hospital

Venice, , Italy

Site Status

Countries

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Italy

References

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Cacciante L, Kiper P, Garzon M, Baldan F, Federico S, Turolla A, Agostini M. Telerehabilitation for people with aphasia: A systematic review and meta-analysis. J Commun Disord. 2021 Jul-Aug;92:106111. doi: 10.1016/j.jcomdis.2021.106111. Epub 2021 May 13.

Reference Type BACKGROUND
PMID: 34052617 (View on PubMed)

Cacciante L, Pieta CD, Rutkowski S, Cieslik B, Szczepanska-Gieracha J, Agostini M, Kiper P. Cognitive telerehabilitation in neurological patients: systematic review and meta-analysis. Neurol Sci. 2022 Feb;43(2):847-862. doi: 10.1007/s10072-021-05770-6. Epub 2021 Nov 25.

Reference Type BACKGROUND
PMID: 34822030 (View on PubMed)

Other Identifiers

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2017.16

Identifier Type: -

Identifier Source: org_study_id

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