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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Telerehabilitation - VRRS Khymeia
Sponsored by
IRCCS San Camillo, Venezia, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Telerehabilitation, Feasibility, Virtual reality

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • IRCCS San Camillo Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Telerehabilitation

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in measure of quality of life
Quality of life will be measured by the Short-Form-36 Health Survey (SF-36), a questionnaire comprising 36 questions that cover 8 domains of health. Each of the 8 summed scores is linearly transformed onto a scale from 0 (negative health) to 100 (positive health) to provide a score for each domain. Each domain can be used independently.
Change in measure of quality of life
Quality of life will be measured by the EuroQol-5 dimensions (EQ-5D), a questionnaire measuring 5 dimensions described by 3 possible levels of problems (i.e., none, mild-to-moderate, severe). Respondent's answers are translated into a preference-based score, yielding an index score based on a scale from 0.000 (death) to 1.000 (perfect health). The 5 dimensions can be converted to a single utility value (EQ-Index score).
Change in motor functions
Change in motor functions will be assessed with the Fugl-Meyer Assessment (FMA), a stroke-specific scale which assesses the motor functioning in patients with post-stroke. There are 3 values for each of the 5 domain: 0 (severe impairment), 1 (moderate impairment), 2 (preserved function). The 5 domains assessed include: motor function (upper limb maximum score = 66; lower limb maximum score = 34), sensory function (maximum score = 24), balance (maximum score = 14), joint range of motion (maximum score = 44), joint pain (maximum score = 44), for an overall maximum score of 226 points.
Change in motor functions
Assessed with the Nine hole pegboard test (NHPT), to measure finger dexterity. It is administered by asking the participant to take the pegs from a container, one by one, and place them into holes on the board as quickly as possible. Scores are based on the time taken to complete the activity, recorded in seconds.
Change in motor functions
Assessed with the Box and block test (BBT). The patient has to carry as much cubes as possible, one by one, from a container to another one in one minute. The test is performed with both hands.
Change in motor functions
Assessed with the Ashworth Spasticity Scale. The therapist evaluates the spasticity of the muscles. There are 5 values: 0 (no increase in muscle tone), 1 (slight increase in muscle tone), 2 (more marked increase in muscle tone), 3 (considerable increase in muscle tone), 4 (affected part rigid in flexion or extension).
Change in linguistic functions
Aachen Aphasie Test (AAT)
Change in cognitive functions
Assessed with the Montreal Cognitive Assessment (MoCA), a cognitive screening tool comprising 16 items and 11 categories to assess multiple cognitive domains. The total possible score is 30, corresponding to a good performance.
Change in cognitive functions
Assessed with the Bells test, a cancellation test that allows for a quantitative and qualitative assessment of visual neglect in the near extra personal space. The total number of cancelled bells is recorded as well as the time taken to complete. The maximum score is 35.
Change in cognitive functions
Assessed with the verbal fluency test. Participants have to produce as many words as possible from a semantic and a phonemic category in 1 minute.
Change in Independence (Activities of Daily Living)
Assessed with the Barthel Index (BI). It comprises 10 ADL/mobility activities, items are rated based on the amount of assistance required to complete each activity. Each item score ranges from 0 (dependent) to 10 (independent).
Change in behavior (depression)
Assessed with the Beck Depression Inventory (BDI). Items are on a four-point scale that ranges from 0 to 3. Ratings are summed to provide a total score ranging from 0-63. Scores >10 generally meet the threshold for a diagnosis of depression.
Change in caregiver burden
Assessed with the Zarit Burden Interview (ZBI). It comprises 22 items with a score ranging from 0 ("never" to 4 ("nearly always"). Total scores are obrained by summing all items endorsed.
Satisfaction of the treatment
Client Satisfaction Questionnaire, it consists of a 6 item questionnaire with five response options: from 0 to 4, where 0 reflects a negative response and 4 reflects a positive response.

Full Information

First Posted
December 12, 2022
Last Updated
January 19, 2023
Sponsor
IRCCS San Camillo, Venezia, Italy
Collaborators
IRCCS Centro Neurolesi Bonino-Pulejo, Messina (IT), Fondazione Don Carlo Gnocchi Onlus, IRCCS Fondazione Istituto Neurologico Casimiro Mondino, Pavia (IT), IRCCS San Raffaele Roma, Istituto Clinico Humanitas
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1. Study Identification

Unique Protocol Identification Number
NCT05703906
Brief Title
Teleneurorehabilitation for the Continuity of Care Post-stroke: a Multicentric Pilot Study
Acronym
TELEICTUS
Official Title
Teleneurorehabilitation for the Continuity of Care Post-stroke: a Multicentric Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
March 16, 2018 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IRCCS San Camillo, Venezia, Italy
Collaborators
IRCCS Centro Neurolesi Bonino-Pulejo, Messina (IT), Fondazione Don Carlo Gnocchi Onlus, IRCCS Fondazione Istituto Neurologico Casimiro Mondino, Pavia (IT), IRCCS San Raffaele Roma, Istituto Clinico Humanitas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Telerehabilitation, Feasibility, Virtual reality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telerehabilitation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Telerehabilitation - VRRS Khymeia
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of telerehabilitation system
Description
Feasibility will be measured by calculating the adherence to treatment (i.e. percentage of training sessions completed).
Time Frame
6 weeks
Title
Feasibility of telerehabilitation system
Description
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.
Time Frame
6 weeks
Title
Feasibility of telerehabilitation system
Description
Feasibility will be measured with the System Usability Questionnaire (SUS), a 10 item questionnaire with five response options: from Strongly agree to Strongly disagree.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Change in measure of quality of life
Description
Quality of life will be measured by the Short-Form-36 Health Survey (SF-36), a questionnaire comprising 36 questions that cover 8 domains of health. Each of the 8 summed scores is linearly transformed onto a scale from 0 (negative health) to 100 (positive health) to provide a score for each domain. Each domain can be used independently.
Time Frame
Baseline up to 6 weeks
Title
Change in measure of quality of life
Description
Quality of life will be measured by the EuroQol-5 dimensions (EQ-5D), a questionnaire measuring 5 dimensions described by 3 possible levels of problems (i.e., none, mild-to-moderate, severe). Respondent's answers are translated into a preference-based score, yielding an index score based on a scale from 0.000 (death) to 1.000 (perfect health). The 5 dimensions can be converted to a single utility value (EQ-Index score).
Time Frame
Baseline up to 6 weeks
Title
Change in motor functions
Description
Change in motor functions will be assessed with the Fugl-Meyer Assessment (FMA), a stroke-specific scale which assesses the motor functioning in patients with post-stroke. There are 3 values for each of the 5 domain: 0 (severe impairment), 1 (moderate impairment), 2 (preserved function). The 5 domains assessed include: motor function (upper limb maximum score = 66; lower limb maximum score = 34), sensory function (maximum score = 24), balance (maximum score = 14), joint range of motion (maximum score = 44), joint pain (maximum score = 44), for an overall maximum score of 226 points.
Time Frame
Baseline up to 6 weeks
Title
Change in motor functions
Description
Assessed with the Nine hole pegboard test (NHPT), to measure finger dexterity. It is administered by asking the participant to take the pegs from a container, one by one, and place them into holes on the board as quickly as possible. Scores are based on the time taken to complete the activity, recorded in seconds.
Time Frame
Baseline up to 6 weeks
Title
Change in motor functions
Description
Assessed with the Box and block test (BBT). The patient has to carry as much cubes as possible, one by one, from a container to another one in one minute. The test is performed with both hands.
Time Frame
Baseline up to 6 weeks
Title
Change in motor functions
Description
Assessed with the Ashworth Spasticity Scale. The therapist evaluates the spasticity of the muscles. There are 5 values: 0 (no increase in muscle tone), 1 (slight increase in muscle tone), 2 (more marked increase in muscle tone), 3 (considerable increase in muscle tone), 4 (affected part rigid in flexion or extension).
Time Frame
Baseline up to 6 weeks
Title
Change in linguistic functions
Description
Aachen Aphasie Test (AAT)
Time Frame
Baseline up to 6 weeks
Title
Change in cognitive functions
Description
Assessed with the Montreal Cognitive Assessment (MoCA), a cognitive screening tool comprising 16 items and 11 categories to assess multiple cognitive domains. The total possible score is 30, corresponding to a good performance.
Time Frame
Baseline up to 6 weeks
Title
Change in cognitive functions
Description
Assessed with the Bells test, a cancellation test that allows for a quantitative and qualitative assessment of visual neglect in the near extra personal space. The total number of cancelled bells is recorded as well as the time taken to complete. The maximum score is 35.
Time Frame
Baseline up to 6 weeks
Title
Change in cognitive functions
Description
Assessed with the verbal fluency test. Participants have to produce as many words as possible from a semantic and a phonemic category in 1 minute.
Time Frame
Baseline up to 6 weeks
Title
Change in Independence (Activities of Daily Living)
Description
Assessed with the Barthel Index (BI). It comprises 10 ADL/mobility activities, items are rated based on the amount of assistance required to complete each activity. Each item score ranges from 0 (dependent) to 10 (independent).
Time Frame
Baseline up to 6 weeks
Title
Change in behavior (depression)
Description
Assessed with the Beck Depression Inventory (BDI). Items are on a four-point scale that ranges from 0 to 3. Ratings are summed to provide a total score ranging from 0-63. Scores >10 generally meet the threshold for a diagnosis of depression.
Time Frame
Baseline up to 6 weeks
Title
Change in caregiver burden
Description
Assessed with the Zarit Burden Interview (ZBI). It comprises 22 items with a score ranging from 0 ("never" to 4 ("nearly always"). Total scores are obrained by summing all items endorsed.
Time Frame
Baseline up to 6 weeks
Title
Satisfaction of the treatment
Description
Client Satisfaction Questionnaire, it consists of a 6 item questionnaire with five response options: from 0 to 4, where 0 reflects a negative response and 4 reflects a positive response.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luisa Cacciante, MSc
Organizational Affiliation
IRCCS San Camillo Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCCS San Camillo Hospital
City
Venice
ZIP/Postal Code
30126
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34052617
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.
Results Reference
background
PubMed Identifier
34822030
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.
Results Reference
background

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

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