Clinical trial NCT05703906: Teleneurorehabilitation for the Continuity of Care Post-stroke: a Multicentric Pilot Study
Official title: Teleneurorehabilitation for the Continuity of Care Post-stroke: a Multicentric Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Telerehabilitation
Feasibility
Virtual reality
Lead sponsor: IRCCS San Camillo, Venezia, Italy
Sponsor class: OTHER
Collaborators: name: IRCCS Centro Neurolesi Bonino Pulejo
name: Fondazione Don Carlo Gnocchi Onlus
name: Fondazione Mondino
name: IRCCS San Raffaele Roma
name: Istituto Clinico Humanitas
First posted: 2023-01-30
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of telerehabilitation system
timeFrame: 6 weeks
measure: Feasibility of telerehabilitation system
timeFrame: 6 weeks
measure: Feasibility of telerehabilitation system
timeFrame: 6 weeks
Secondary outcomes:
measure: Change in measure of quality of life
timeFrame: Baseline up to 6 weeks
measure: Change in measure of quality of life
timeFrame: Baseline up to 6 weeks
measure: Change in motor functions
timeFrame: Baseline up to 6 weeks
measure: Change in motor functions
timeFrame: Baseline up to 6 weeks
measure: Change in motor functions
timeFrame: Baseline up to 6 weeks
measure: Change in motor functions
timeFrame: Baseline up to 6 weeks
measure: Change in linguistic functions
timeFrame: Baseline up to 6 weeks
measure: Change in cognitive functions
timeFrame: Baseline up to 6 weeks
measure: Change in cognitive functions
timeFrame: Baseline up to 6 weeks
measure: Change in cognitive functions
timeFrame: Baseline up to 6 weeks
measure: Change in Independence (Activities of Daily Living)
timeFrame: Baseline up to 6 weeks
measure: Change in behavior (depression)
timeFrame: Baseline up to 6 weeks
measure: Change in caregiver burden
timeFrame: Baseline up to 6 weeks
measure: Satisfaction of the treatment
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Venice
country: Italy
facility: IRCCS San Camillo Hospital
Study officials:
affiliation: IRCCS San Camillo Hospital
name: Luisa Cacciante, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.