RehabilitationNCT06795672
Tele-rehabilitation for Cognitive Disorders
A study testing Telerehabilitation and Traditional in-person rehabilitation. in people with Rehabilitation and Stroke, run by Universita di Verona at 1 site in Italy.
Trial summary
The aim of the study is to evaluate whether a computer-based cognitive treatment delivered via tele-rehabilitation produces an improvement in cognitive functioning comparable to the improvement achievable through the same treatment delivered in person in patients with stroke outcomes. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Rehabilitation, Stroke, Telerehabilitation
- What is being tested?
- Telerehabilitation and Traditional in-person rehabilitation.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteItaly
- Study dates
- 28 Mar 2022to 31 Mar 2024
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of ischemic or hemorrhagic stroke;
- Age between 18 and 90 years;
- First stroke event;
- Stroke occurred more than 30 days ago;
- Adequate level of understanding;
- Presence of one or more of the following cognitive disorders:
Show all 10Show fewer
- Memory disorders
- Attention disorders
- Executive function disorders
- Availability of an internet connection at the patient's home necessary for the telemedicine procedures.
Who cannot join
- Presence of other neurological disorders;
- Presence of pre-morbid cognitive decline;
- Psychiatric disorders in the medical history;
- Alcohol and/or drug abuse;
- Presence of severe uncorrected visual deficits.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Sezione medicina fisica e riabilitativa dipartimento di neuroscienze
Verona, verona
About this study
Official title: Tele-rehabilitation for Cognitive Disorders: a Randomized Controlled Trial in Patients with Stroke Outcomes
The aim of the study is to evaluate whether a computer-based cognitive treatment delivered via tele-rehabilitation produces an improvement in cognitive functioning comparable to the improvement achievable through the same treatment delivered in person in patients with stroke outcomes.
To investigate, using a custom-designed questionnaire, the feasibility and patient satisfaction with the rehabilitative treatment delivered via telemedicine compared to the same treatment delivered in person.
- Conditions
- Rehabilitation, Stroke, Telerehabilitation, Telemedicine
- Being tested
- Telerehabilitation, Traditional in-person rehabilitation.
- Keywords
- stroke, telemedicine, rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelerehabilitationBehavioural
Three hours of cognitive rehabilitation per week, performed remotely and independently, using a computerized device, which is pre-programmed based on the patient's needs.
Traditional in-person rehabilitation.Behavioural
Three hours of in-person cognitive rehabilitation per week using a computerized device.
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation group | Experimental | Three hours of cognitive rehabilitation per week, performed remotely and independently, using a computerized device, which is pre-programmed based on the patient's needs. Receives: Behavioral: Telerehabilitation |
| In-person treatment | Active comparator | Three hours of in-person cognitive rehabilitation per week using a computerized device. Receives: Behavioral: Traditional in-person rehabilitation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trail Making Test Part B (TMT-B)
Used as a measure of attentional set-shifting and mental flexibility. Time needed to complete the tasks is recorded.
Measured: From enrollment to the end of treatment and 2 months until the end of treatment
Secondary outcomes (10)
The Trail Making Test - A (TMT-A)
Used as a measure of psychomotor speed and visual search/attention skills
Measured: From enrollment to the end of treatment and 2 months until the end of treatment
15 Words of Rey
To assess verbal learning ability and long-term verbal memory (IMMEDIATE RECALL: score ranging from 0 to 75. DELAYED RECALL: score ranging from 0 to 15).
Measured: From enrollment to the end of treatment and 2 months until the end of treatment
Memory with interference - ENB 2
to assess working memory through the memorization of letter triplets alongside a distracting task lasting 10 seconds in the first part and 30 seconds in the second. The maximum obtainable score is 9 for both parts of the test.
Measured: From enrollment to the end of treatment and 2 months until the end of treatment
Dual task test
Dual Task to assess the ability to perform two tasks simultaneously (one verbal and one visuomotor)
Measured: From enrollment to the end of treatment and 2 months until the end of treatment
Elithorn's Perceptual Maze Test
to investigate problem-solving abilities.
Measured: From enrollment to the end of treatment and 2 months until the end of treatment
Stroop Test
to assess the speed and accuracy of automatic response inhibition.
Measured: From enrollment to the end of treatment and 2 months until the end of treatment
Functional Independence Measure (FIM)
To evaluate the degree of disability.
Measured: From enrollment to the end of treatment and 2 months until the end of treatment
Hospital Anxiety and Depression Scale
to assess the presence of depression and anxiety.
Measured: From enrollment to the end of treatment and 2 months until the end of treatment
Short Form Health Survey 36 (SF-36)
to evaluate quality of life.
Measured: From enrollment to the end of treatment and 2 months until the end of treatment
Feasibility, Satisfaction, and Cost Questionnaire
to assess the feasibility and satisfaction with the treatment and to evaluate the costs associated with it.
Measured: From enrollment to the end of treatment and 2 months until the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start28 Mar 2022
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Why it stopped: Difficulties in patient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RehabilitationStudies 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
- Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valentina Varalta, Universita di Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06795672
- Sponsor's protocol ID
- 3623CESC
- Status last verified
- Mar 2022
- First submitted
- 21 Jan 2025
- Last updated
- 28 Jan 2025
- 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 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tele-rehabilitation for Cognitive Disorders: a Randomized Controlled Trial in Patients with Stroke Outcomes
- ClinicalTrials.gov ID
- NCT06795672
- Acronym / sponsor ID
- 3623CESC
- Conditions
- Rehabilitation, Stroke, Telerehabilitation, Telemedicine
- Keywords
- stroke, telemedicine, rehabilitation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties in patient recruitment
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 28 Jan 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 aim of the study is to evaluate whether a computer-based cognitive treatment delivered via tele-rehabilitation produces an improvement in cognitive functioning comparable to the improvement achievable through the same treatment delivered in person in patients with stroke outcomes.
To investigate, using a custom-designed questionnaire, the feasibility and patient satisfaction with the rehabilitative treatment delivered via telemedicine compared to the same treatment delivered in person.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation group | Experimental | Behavioral: TelerehabilitationThree hours of cognitive rehabilitation per week, performed remotely and independently, using a computerized device, which is pre-programmed based on the patient's needs. |
| In-person treatment | Active comparator | Behavioral: Traditional in-person rehabilitation.Three hours of in-person cognitive rehabilitation per week using a computerized device. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Diagnosis of ischemic or hemorrhagic stroke;
- Age between 18 and 90 years;
- First stroke event;
- Stroke occurred more than 30 days ago;
- Adequate level of understanding;
Key exclusion criteria (5 listed)
- Presence of other neurological disorders;
- Presence of pre-morbid cognitive decline;
- Psychiatric disorders in the medical history;
- Alcohol and/or drug abuse;
- Presence of severe uncorrected visual deficits.
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 |
|---|---|---|
| TelerehabilitationThree hours of cognitive rehabilitation per week, performed remotely and independently, using a computerized device, which is pre-programmed based on the patient's needs. | Behavioural | Telerehabilitation group |
| Traditional in-person rehabilitation.Three hours of in-person cognitive rehabilitation per week using a computerized device. | Behavioural | In-person treatment |
Primary outcome
Trail Making Test Part B (TMT-B)
Time frame: From enrollment to the end of treatment and 2 months until the end of treatment
Used as a measure of attentional set-shifting and mental flexibility. Time needed to complete the tasks is recorded.
10 secondary outcomes
The Trail Making Test - A (TMT-A)
Time frame: From enrollment to the end of treatment and 2 months until the end of treatment
15 Words of Rey
Time frame: From enrollment to the end of treatment and 2 months until the end of treatment
Memory with interference - ENB 2
Time frame: From enrollment to the end of treatment and 2 months until the end of treatment
Dual task test
Time frame: From enrollment to the end of treatment and 2 months until the end of treatment
Elithorn's Perceptual Maze Test
Time frame: From enrollment to the end of treatment and 2 months until the end of treatment
Stroop Test
Time frame: From enrollment to the end of treatment and 2 months until the end of treatment
Functional Independence Measure (FIM)
Time frame: From enrollment to the end of treatment and 2 months until the end of treatment
Hospital Anxiety and Depression Scale
Time frame: From enrollment to the end of treatment and 2 months until the end of treatment
Short Form Health Survey 36 (SF-36)
Time frame: From enrollment to the end of treatment and 2 months until the end of treatment
Feasibility, Satisfaction, and Cost Questionnaire
Time frame: From enrollment to the end of treatment and 2 months until the end of treatment
Results and safety
The study was stopped early (reason given: Difficulties in patient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
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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 Telerehabilitation and Traditional in-person rehabilitation. in people with Rehabilitation and Stroke, run by Universita di Verona 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 10 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: stopped early, as of the sponsor's last update on 28 Jan 2025. 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 was stopped early (reason given: Difficulties in patient recruitment). Results are not available in the source record.
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?
Trail Making Test Part B (TMT-B) (time frame: From enrollment to the end of treatment and 2 months until the end of treatment). 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 28 Jan 2025.