NCT05703906

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable stroke

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

March 16, 2018

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 30, 2023

Completed
Last Updated

January 30, 2023

Status Verified

December 1, 2022

Enrollment Period

3.7 years

First QC Date

December 12, 2022

Last Update Submit

January 19, 2023

Conditions

Stroke

Keywords

StrokeTelerehabilitationFeasibilityVirtual reality

Outcome Measures

Primary Outcomes (3)

  • Feasibility of telerehabilitation system

    Feasibility will be measured by calculating the adherence to treatment (i.e. percentage of training sessions completed).

    6 weeks

  • Feasibility of telerehabilitation system

    Feasibility will be measured with the Technology Acceptance Model (TAM), a specific questionnaire used to quantify the likelihood of technology acceptance, consisting of 12 items, six assessing perceived usefulness and six assessing perceived ease of use.

    6 weeks

  • Feasibility of telerehabilitation system

    Feasibility will be measured with the System Usability Questionnaire (SUS), a 10 item questionnaire with five response options: from Strongly agree to Strongly disagree.

    6 weeks

Secondary Outcomes (14)

  • Change in measure of quality of life

    Baseline up to 6 weeks

  • Change in measure of quality of life

    Baseline up to 6 weeks

  • Change in motor functions

    Baseline up to 6 weeks

  • Change in motor functions

    Baseline up to 6 weeks

  • Change in motor functions

    Baseline up to 6 weeks

  • +9 more secondary outcomes

Study Arms (1)

Telerehabilitation

EXPERIMENTAL

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.

Behavioral: Telerehabilitation - VRRS Khymeia

Interventions

Telerehabilitation - VRRS KhymeiaBEHAVIORAL

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.

Telerehabilitation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS San Camillo Hospital

Venice, 30126, Italy

Location

Related Publications (2)

  • 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.

    PMID: 34052617BACKGROUND

  • 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.

    PMID: 34822030BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Luisa Cacciante, MSc

    IRCCS San Camillo Hospital

    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
SPONSOR

Study Record Dates

First Submitted

December 12, 2022

First Posted

January 30, 2023

Study Start

March 16, 2018

Primary Completion

November 30, 2021

Study Completion

December 31, 2021

Last Updated

January 30, 2023

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)