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

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Behavioral: Telerehabilitation - VRRS Khymeia

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Venice, Italy, 30126
    • IRCCS San Camillo Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline up to 6 weeks
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).	Baseline up to 6 weeks
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.	Baseline up to 6 weeks
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.	Baseline up to 6 weeks
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.	Baseline up to 6 weeks
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).	Baseline up to 6 weeks
Change in linguistic functions	Aachen Aphasie Test (AAT)	Baseline up to 6 weeks
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.	Baseline up to 6 weeks
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.	Baseline up to 6 weeks
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.	Baseline up to 6 weeks
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).	Baseline up to 6 weeks
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.	Baseline up to 6 weeks
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.	Baseline up to 6 weeks
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.	6 weeks

Collaborators and Investigators

• Sponsor: IRCCS San Camillo, Venezia, Italy
• Collaborators: Fondazione Don Carlo Gnocchi Onlus; Istituto Clinico Humanitas; IRCCS San Raffaele Roma; IRCCS Centro Neurolesi Bonino-Pulejo, Messina (IT); IRCCS Fondazione Istituto Neurologico Casimiro Mondino, Pavia (IT)
• Investigators: Principal Investigator: Luisa Cacciante, MSc, IRCCS San Camillo Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2018
• Primary Completion (Actual): November 30, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: December 12, 2022
• First Submitted That Met QC Criteria: January 19, 2023
• First Posted (Estimate): January 30, 2023

Study Record Updates

• Last Update Posted (Estimate): January 30, 2023
• Last Update Submitted That Met QC Criteria: January 19, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Stroke; Feasibility; Telerehabilitation; Virtual reality
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 2017.16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No