Cognitive ImpairmentCIPS-TERNCT07251517
Cognitive Rehabilitation in Post-stroke Cognitive Impairment
A study testing Cognitive telerehabilitation treatment in people with Cognitive Impairment and Stroke Acute, run by University of Florence at 1 site in Italy.
Trial summary
The goal of this 2-year, prospective, single-blind randomized clinical trial is to investigate: the efficacy in reducing the risk of cognitive impairment 6 months after stroke; the generalizability of cognitive reinforcement to real life, such as activities of daily living and quality of life; and the impact on… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cognitive Impairment, Stroke Acute
- What is being tested?
- Cognitive telerehabilitation treatment
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteItaly
- Study dates
- 22 Apr 2024to 20 Mar 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Diagnosis of ischemic or hemorrhagic stroke between 5 and 21 days after the event
- Ability to express written informed consent
- Evidence of impairment of global cognitive efficiency according to the post-stroke MoCA (MoCA total score≤21)
- Normal stenia of at least one upper limb (NIHSS motor item of at least one upper limb=0)
Who cannot join
- Pre-existing dementia (IQ-CODE>3.48 and/or diagnosis of dementia by a specialist).
- Severe aphasia (NIHSS language item ≥2 and impaired performance on the Token test, i.e. a correct score below the 5th centile of the normal population).
- Withdrawal of informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive Impairment Post Stroke: a Single-blinded Randomized Trial on the Efficacy of TEleRehabilitation. The CIPS-TER Study
The goal of this 2-year, prospective, single-blind randomized clinical trial is to investigate: the efficacy in reducing the risk of cognitive impairment 6 months after stroke; the generalizability of cognitive reinforcement to real life, such as activities of daily living and quality of life; and the impact on cognitive performance. In the treatment group, feasibility, adherence, and satisfaction with the cognitive telerehabilitation program will also be evaluated. Participants will be adult patients with a diagnosis of ischemic or hemorrhagic stroke, within 5-21 days after onset.
The main outcomes to be evaluated are:
Read more
- diagnosis of cognitive impairment (primary outcome);
- activities of daily living, quality of life, changes in frailty status, and cognitive efficiency (secondary outcomes).
There will be two groups: a treatment group and a control group. Participants in the treatment group will undergo a cognitive telerehabilitation program of 40 hours over 8 weeks, while participants in the control group will be instructed to follow their standard care.
Read the detailed description
Despite its social and economic burden, cognitive impairment after stroke is still a neglected consequence compared to other neurological deficits for which rehabilitation pathways are routinely available. Cognitive telerehabilitation represents an emerging, promising and innovative approach that has the potential to provide both an individualized treatment and the opportunity of access to services for a wide catchment area.
CIPS-TER study is a 2-year prospective, single-blind, randomized clinical trial. A cognitive telerehabilitation program, versus standard care, will be administered to a cohort of stroke patients with the aims to investigate: efficacy in reducing the risk of cognitive impairment 6 months after stroke; generalizability of the cognitive reinforcement to real life, such as activities in daily living and quality of life; and impact on cognitive performances. In the treated group, feasibility, adherence and appreciation of the cognitive telerehabilitation program will also be evaluated. During an enrolment period of 12 months, all adult patients consecutively admitted to Stroke Unit of Careggi University Hospital and/or to Intensive Rehabilitation Unit of IRCCS Don Gnocchi in Florence with a diagnosis of ischemic or hemorrhagic stroke will be evaluated, within 5-21 days after onset, for the inclusion in the study.
After baseline assessment, the foreseen cohort of 100 enrolled patients will be randomly assigned to treatment or control group. The cognitive telerehabilitation program (Virtual Reality Rehabilitation System, Khymeia) will consist of up to 40 hours (8 weeks) of individual treatment based on memory, attention and executive functions, and visuospatial tasks to be to autonomously performed with a tablet. All patients will be followed after 2 months (brief cognitive assessment) and after 6 months (comprehensive clinical, functional, and cognitive assessment). The study outcomes will be evaluated at 6-month follow-up visit and will include the diagnosis of cognitive impairment (primary outcome), and activities of daily living, quality of life, changes in frailty status and cognitive efficiency (secondary outcomes). The results of CIPS-TER study will contribute to our knowledge on the potentials of an early cognitive telerehabilitation on the reduction of persistent cognitive and functional burden in stroke patients, and thus on the utility to consider cognitive telerehabilitation as an effective component of post-stroke care pathways. In line with precision medicine, CIPS-TER project could also help to highlight which clinical features characterize those stroke patients that could maximally benefit of such cognitive interventions. Finally, experiences and setups gathered within CIPS-TER project could represent a technical and methodological background for future studies aimed at the development and/or the evaluation of cognitive telerehabilitation systems in stroke patients.
- Conditions
- Cognitive Impairment, Stroke Acute
- Being tested
- Cognitive telerehabilitation treatment
- Keywords
- cognitive telerehabilitation, stroke, cognitive impairment, neuropsychology
- Medical subject headings
- Cognitive Dysfunction, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive telerehabilitation treatmentProcedure or surgery
The subjects who will be part of the experimental group will receive a total of up to 40 hours of individual treatment. Cognitive telerehabilitation will be administered in five weekly sessions of 60 minutes each for a total of 8 weeks. The cognitive treatment will include twenty-four exercises aimed at improving memory, attention, executive functions and visuospatial skills. In each treatment session, participants will work with six exercises, lasting 10 minutes each, and the difficulty of the task will increase adaptively over the course of the home sessions.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive telerehabilitation treatment | Experimental | The cognitive telerehabilitation program will be based on the Virtual Reality Rehabilitation System (VRRS) of the Khymeia group (Noventa Padovana, Italy). The VRRS equipment includes a central workstation located in the clinical center and VRRS tablet devices used independently by patients to perform cognitive exercises. The cognitive modules of the VRRS include a broad set of tasks for each major cognitive domain. Tasks can be customized and supervised from the central workstation and comprehensive automatic reports are available for each rehabilitation session. Receives: Procedure: Cognitive telerehabilitation treatment |
| Standard Care | No intervention | Participants in the control group, "standard care", will be instructed to have a usual lifestyle and will receive conventional treatments and clinical indications provided by referring doctors. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of the risk of cognitive impairment post stroke in the medium-long term
The primary endpoint will be the diagnosis of cognitive impairment, which will include both mild cognitive impairment (MCI) and dementia and will be made according to the DSM-5 criteria for the diagnosis of mild or major neurocognitive disorders, respectively.
Measured: From enrollment to 6 months after stroke
Secondary outcomes (4)
Quality of life post-stroke
Secondary endpoint will be quality of life post-stroke. Quality of life measured by means of the Stroke-adapted sickness impact profile (SA-SIP, score 0-100) scale and Euro Quality of Life visual scale (EuroQoL, score 0-100). In the SA-SIP scale high scores indicate a strong impact of the disease. To calculate the score, the items must be weighted, added up for each subscale, and expressed as a percentage for each subscale from 0 to 100%. As regards EuroQOL, high scores mean better outcomes.
Measured: From enrollment to 6 months after stroke
Independence in activities of daily living post-stroke
Another secondary endpoint will be independence in activities of daily living post-stroke. Functional status measured by means of the Activities of Daily Living scale (ADL) Instrumental Activities of Daily Living scale (IADL). ADL score 0-6, IADL score 0-22. Higher scores mean a better outcome.
Measured: From enrollment to 6 months after stroke
Changes in frailty status post-stroke
Another endpoint will be changes in frailty status post-stroke. Frailty measured according to the Italian version of the Tilburg Frailty Indicator (TFI). The TFI is an easy and simple to administer self-report questionnaire developed to evaluate frailty in community-dwelling older adults (Total score 0-15). Each patient that will obtain a total score 5 will be classified as frail. Higher scores mean worse outcome.
Measured: From enrollment to 6 months after stroke
Impact on cognitive performance
Another endpoint will be impact on cognitive performance and changes in cognitive efficiency. Cognitive performances at the multidomain neuropsychological battery will be compared between telerehabilitation and standard care groups in order to evaluate a potential treatment benefit on the overall cognitive profile. Higher scores mean a better outcome.
Measured: From enrollment to 6 months after stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start22 Apr 2024
- Primary completion20 Mar 2026
- Study completion20 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florence
- Sponsor type
- University, hospital or other
- Collaborators
- University of Milan, University of Pavia
- Responsible party
- Principal investigator, Anna Poggesi, University of Florence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07251517
- Sponsor's protocol ID
- 25546
- Acronym
- CIPS-TER
- Status last verified
- Oct 2025
- First submitted
- 2 Oct 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Impairment Post Stroke: a Single-blinded Randomized Trial on the Efficacy of TEleRehabilitation. The CIPS-TER Study
- ClinicalTrials.gov ID
- NCT07251517
- Acronym / sponsor ID
- CIPS-TER / 25546
- Conditions
- Cognitive Impairment, Stroke Acute
- Keywords
- cognitive telerehabilitation, stroke, cognitive impairment, neuropsychology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of FlorenceUniversity, hospital or other
- Collaborators
- University of Milan, University of Pavia
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 20 Mar 2026 (actual)
- Study completion
- 20 Mar 2026 (actual)
- First posted
- 26 Nov 2025 (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 goal of this 2-year, prospective, single-blind randomized clinical trial is to investigate: the efficacy in reducing the risk of cognitive impairment 6 months after stroke; the generalizability of cognitive reinforcement to real life, such as activities of daily living and quality of life; and the impact on cognitive performance. In the treatment group, feasibility, adherence, and satisfaction with the cognitive telerehabilitation program will also be evaluated. Participants will be adult patients with a diagnosis of ischemic or hemorrhagic stroke, within 5-21 days after onset.
The main outcomes to be evaluated are:
- diagnosis of cognitive impairment (primary outcome);
- activities of daily living, quality of life, changes in frailty status, and cognitive efficiency (secondary outcomes).
There will be two groups: a treatment group and a control group. Participants in the treatment group will undergo a cognitive telerehabilitation program of 40 hours over 8 weeks, while participants in the control group will be instructed to follow their standard care.
Detailed description
Despite its social and economic burden, cognitive impairment after stroke is still a neglected consequence compared to other neurological deficits for which rehabilitation pathways are routinely available. Cognitive telerehabilitation represents an emerging, promising and innovative approach that has the potential to provide both an individualized treatment and the opportunity of access to services for a wide catchment area.
CIPS-TER study is a 2-year prospective, single-blind, randomized clinical trial. A cognitive telerehabilitation program, versus standard care, will be administered to a cohort of stroke patients with the aims to investigate: efficacy in reducing the risk of cognitive impairment 6 months after stroke; generalizability of the cognitive reinforcement to real life, such as activities in daily living and quality of life; and impact on cognitive performances. In the treated group, feasibility, adherence and appreciation of the cognitive telerehabilitation program will also be evaluated. During an enrolment period of 12 months, all adult patients consecutively admitted to Stroke Unit of Careggi University Hospital and/or to Intensive Rehabilitation Unit of IRCCS Don Gnocchi in Florence with a diagnosis of ischemic or hemorrhagic stroke will be evaluated, within 5-21 days after onset, for the inclusion in the study.
After baseline assessment, the foreseen cohort of 100 enrolled patients will be randomly assigned to treatment or control group. The cognitive telerehabilitation program (Virtual Reality Rehabilitation System, Khymeia) will consist of up to 40 hours (8 weeks) of individual treatment based on memory, attention and executive functions, and visuospatial tasks to be to autonomously performed with a tablet. All patients will be followed after 2 months (brief cognitive assessment) and after 6 months (comprehensive clinical, functional, and cognitive assessment). The study outcomes will be evaluated at 6-month follow-up visit and will include the diagnosis of cognitive impairment (primary outcome), and activities of daily living, quality of life, changes in frailty status and cognitive efficiency (secondary outcomes). The results of CIPS-TER study will contribute to our knowledge on the potentials of an early cognitive telerehabilitation on the reduction of persistent cognitive and functional burden in stroke patients, and thus on the utility to consider cognitive telerehabilitation as an effective component of post-stroke care pathways. In line with precision medicine, CIPS-TER project could also help to highlight which clinical features characterize those stroke patients that could maximally benefit of such cognitive interventions. Finally, experiences and setups gathered within CIPS-TER project could represent a technical and methodological background for future studies aimed at the development and/or the evaluation of cognitive telerehabilitation systems in stroke patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive telerehabilitation treatment | Experimental | Procedure: Cognitive telerehabilitation treatmentThe cognitive telerehabilitation program will be based on the Virtual Reality Rehabilitation System (VRRS) of the Khymeia group (Noventa Padovana, Italy). The VRRS equipment includes a central workstation located in the clinical center and VRRS tablet devices used independently by patients to perform cognitive exercises. The cognitive modules of the VRRS include a broad set of tasks for each major cognitive domain. Tasks can be customized and supervised from the central workstation and comprehensive automatic reports are available for each rehabilitation session. |
| Standard Care | No intervention | –Participants in the control group, "standard care", will be instructed to have a usual lifestyle and will receive conventional treatments and clinical indications provided by referring doctors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Diagnosis of ischemic or hemorrhagic stroke between 5 and 21 days after the event
- Ability to express written informed consent
- Evidence of impairment of global cognitive efficiency according to the post-stroke MoCA (MoCA total score≤21)
- Normal stenia of at least one upper limb (NIHSS motor item of at least one upper limb=0)
Key exclusion criteria (3 listed)
- Pre-existing dementia (IQ-CODE>3.48 and/or diagnosis of dementia by a specialist).
- Severe aphasia (NIHSS language item ≥2 and impaired performance on the Token test, i.e. a correct score below the 5th centile of the normal population).
- Withdrawal of informed consent
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 |
|---|---|---|
| Cognitive telerehabilitation treatmentThe subjects who will be part of the experimental group will receive a total of up to 40 hours of individual treatment. Cognitive telerehabilitation will be administered in five weekly sessions of 60 minutes each for a total of 8 weeks. The cognitive treatment will include twenty-four exercises aimed at improving memory, attention, executive functions and visuospatial skills. In each treatment session, participants will work with six exercises, lasting 10 minutes each, and the difficulty of the task will increase adaptively over the course of the home sessions. | Procedure or surgery | Cognitive telerehabilitation treatment |
Primary outcome
Reduction of the risk of cognitive impairment post stroke in the medium-long term
Time frame: From enrollment to 6 months after stroke
The primary endpoint will be the diagnosis of cognitive impairment, which will include both mild cognitive impairment (MCI) and dementia and will be made according to the DSM-5 criteria for the diagnosis of mild or major neurocognitive disorders, respectively.
4 secondary outcomes
Quality of life post-stroke
Time frame: From enrollment to 6 months after stroke
Independence in activities of daily living post-stroke
Time frame: From enrollment to 6 months after stroke
Changes in frailty status post-stroke
Time frame: From enrollment to 6 months after stroke
Impact on cognitive performance
Time frame: From enrollment to 6 months after stroke
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 29 Apr 2026.
Related trials for Cognitive Impairment
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Recruiting
HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
Alzheimer Disease, Dementia
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Community-based Screening for Alzheimer's Disease
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive telerehabilitation treatment in people with Cognitive Impairment and Stroke Acute, run by University of Florence 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 5 inclusion and 3 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 29 Apr 2026. 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?
Reduction of the risk of cognitive impairment post stroke in the medium-long term (time frame: From enrollment to 6 months after stroke). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2026.