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StrokeTELEICTUSNCT05703906

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

A study testing Telerehabilitation - VRRS Khymeia in people with Stroke, run by IRCCS San Camillo, Venezia, Italy at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Stroke
What is being tested?
Telerehabilitation - VRRS Khymeia
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteItaly
Study dates
16 Mar 2018to 31 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • IRCCS San Camillo Hospital

    Venice, 30126

Other trials in Italy

About this study

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.

Conditions
Stroke
Being tested
Telerehabilitation - VRRS Khymeia
Keywords
Stroke, Telerehabilitation, Feasibility, Virtual reality
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telerehabilitation - VRRS KhymeiaBehavioural

    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.

Study groups in NCT05703906
Study groupRoleWhat they receive
TelerehabilitationExperimentalAll 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.
Receives: Behavioral: Telerehabilitation - VRRS Khymeia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of telerehabilitation system

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

    Measured: 6 weeks

  2. 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.

    Measured: 6 weeks

  3. 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.

    Measured: 6 weeks

Secondary outcomes (14)
  1. 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.

    Measured: Baseline up to 6 weeks

  2. 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).

    Measured: Baseline up to 6 weeks

  3. 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.

    Measured: Baseline up to 6 weeks

  4. 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.

    Measured: Baseline up to 6 weeks

  5. 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.

    Measured: Baseline up to 6 weeks

  6. 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).

    Measured: Baseline up to 6 weeks

  7. Change in linguistic functions

    Aachen Aphasie Test (AAT)

    Measured: Baseline up to 6 weeks

  8. 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.

    Measured: Baseline up to 6 weeks

  9. 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.

    Measured: Baseline up to 6 weeks

  10. 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.

    Measured: Baseline up to 6 weeks

  11. 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).

    Measured: Baseline up to 6 weeks

  12. 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.

    Measured: Baseline up to 6 weeks

  13. 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.

    Measured: Baseline up to 6 weeks

  14. 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.

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2023
  2. Study start16 Mar 2018
  3. Primary completion30 Nov 2021
  4. Study completion31 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05703906
Sponsor's protocol ID
2017.16
Acronym
TELEICTUS
Status last verified
Dec 2022
First submitted
12 Dec 2022
Last updated
30 Jan 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 34052617
  • 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.

    PubMed 34822030

Questions about this trial

What is this clinical trial studying?

A study testing Telerehabilitation - VRRS Khymeia in people with Stroke, run by IRCCS San Camillo, Venezia, Italy at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of telerehabilitation system (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05703906, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2023.

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