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.
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
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- 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.
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Telerehabilitation - VRRS Khymeia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of telerehabilitation system
Feasibility will be measured by calculating the adherence to treatment (i.e. percentage of training sessions completed).
Measured: 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.
Measured: 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.
Measured: 6 weeks
Secondary outcomes (14)
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
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
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
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
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
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
Change in linguistic functions
Aachen Aphasie Test (AAT)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start16 Mar 2018
- Primary completion30 Nov 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- IRCCS San Camillo, Venezia, Italy
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS Centro Neurolesi Bonino Pulejo, Fondazione Don Carlo Gnocchi ETS, IRCCS National Neurological Institute "C. Mondino" Foundation, IRCCS San Raffaele Roma, Istituto Clinico Humanitas
- Responsible party
- Sponsor
- Investigators
- Luisa Cacciante, MSc, Principal investigator, IRCCS San Camillo Hospital
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 34052617Cacciante 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Teleneurorehabilitation for the Continuity of Care Post-stroke: a Multicentric Pilot Study
- ClinicalTrials.gov ID
- NCT05703906
- Acronym / sponsor ID
- TELEICTUS / 2017.16
- Conditions
- Stroke
- Keywords
- Stroke, Telerehabilitation, Feasibility, Virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- IRCCS San Camillo, Venezia, ItalyUniversity, hospital or other
- Collaborators
- IRCCS Centro Neurolesi Bonino Pulejo, Fondazione Don Carlo Gnocchi ETS, IRCCS National Neurological Institute "C. Mondino" Foundation, IRCCS San Raffaele Roma, Istituto Clinico Humanitas
- Study start
- 16 Mar 2018 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 30 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation | Experimental | Behavioral: Telerehabilitation - VRRS KhymeiaAll 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Single ischemic stroke documented by CT/ MRI;
- 2 to 18 months after the event.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telerehabilitation - VRRS KhymeiaParticipants 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. | Behavioural | Telerehabilitation |
Primary outcome
Feasibility of telerehabilitation system
Time frame: 6 weeks
Feasibility will be measured by calculating the adherence to treatment (i.e. percentage of training sessions completed).
Feasibility of telerehabilitation system
Time frame: 6 weeks
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
Time frame: 6 weeks
Feasibility will be measured with the System Usability Questionnaire (SUS), a 10 item questionnaire with five response options: from Strongly agree to Strongly disagree.
14 secondary outcomes
Change in measure of quality of life
Time frame: Baseline up to 6 weeks
Change in measure of quality of life
Time frame: Baseline up to 6 weeks
Change in motor functions
Time frame: Baseline up to 6 weeks
Change in motor functions
Time frame: Baseline up to 6 weeks
Change in motor functions
Time frame: Baseline up to 6 weeks
Change in motor functions
Time frame: Baseline up to 6 weeks
Change in linguistic functions
Time frame: Baseline up to 6 weeks
Change in cognitive functions
Time frame: Baseline up to 6 weeks
Change in cognitive functions
Time frame: Baseline up to 6 weeks
Change in cognitive functions
Time frame: Baseline up to 6 weeks
Change in Independence (Activities of Daily Living)
Time frame: Baseline up to 6 weeks
Change in behavior (depression)
Time frame: Baseline up to 6 weeks
Change in caregiver burden
Time frame: Baseline up to 6 weeks
Satisfaction of the treatment
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2023.
- Background: PubMed 34052617Cacciante 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.
- Background: PubMed 34822030Cacciante 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.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luisa Cacciante, MSc principal investigator
IRCCS San Camillo Hospital
1 site in 1 country: see every site and its status.
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.