StrokeNCT07458308
Comparison of Blended Care Outpatient Neurorehabilitation With Traditional Outpatient Neurorehabilitation
A study testing Blended care outpatient neurorehabilitation in people with Stroke and Intracerebral Haemorrhage, run by Luzerner Kantonsspital at 1 site in Switzerland.
Trial summary
What is this study about? Outpatient neurorehabilitation (therapy after leaving the hospital) is an important follow-up treatment for people who have had a stroke, brain bleeding, or serious head injury. It helps improve problems with movement, speech, memory, or daily activities. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Intracerebral Haemorrhage, Brain Trauma
- What is being tested?
- Blended care outpatient neurorehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 7 Apr 2026to Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Diagnosis of ischemic or haemorragic stroke or brain trauma.
- People for whom at least 6 weeks of outpatient rehabilitation is foreseen to be indicated.
- Ability for safe independent mobilisation (screening with MiniBesTest, Chedoke)
- Access to and ability to operate MS Teams and Apps on computer and other digital devices (Smartphone, Tablet) (Screening with AST, LAST and NHPT)
- Able to provide informed consent in German.
- Age: 18 - 80 years
Who cannot join
- Severe cardiopulmonary disease
- Other neurological disease than mentioned in the inclusion criteria
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Blended Care Outpatient Neurorehabilitation With Traditional Outpatient Neurorehabilitation, a Crossover Pilot Study
What is this study about? Outpatient neurorehabilitation (therapy after leaving the hospital) is an important follow-up treatment for people who have had a stroke, brain bleeding, or serious head injury. It helps improve problems with movement, speech, memory, or daily activities.
At the same time, there are not enough healthcare professionals, and healthcare costs are rising. Because of this, we need new and more efficient ways to provide therapy.
Read more
One possible solution is telerehabilitation. This means patients do part of their therapy at home using video calls and apps. Early studies show that this can work well. However, in Switzerland it is still rarely used. One reason is that digital therapies are often not paid for, and there is still limited scientific proof of how effective they are.
In this study, the investigators want to find out how well a combination of traditional in-person therapy and digital therapy at home works. The goal is to make treatment more modern, effective, and affordable - benefiting patients, therapists, and the healthcare system.
How is the study organized?
Participants in the study are randomly divided into two groups.
Group 1:
First, participants have three weeks of combined therapy:
- therapy day per week at the hospital.
- therapy days per week at home via Microsoft Teams video calls. On home days, participants also complete exercises using apps provided by their therapists.
After that, participants have three weeks of therapy fully at the hospital (3 days per week).
Group 2:
First, participants have three weeks of therapy at the hospital (3 days per week).
After that, participants have three weeks of combined therapy (hospital + home video therapy).
Both groups receive the same types of therapy, just in a different order. This is called a crossover design.
Because this is one of the first studies of its kind, the investigators are starting with a small number of participants. This is called a pilot study.
Read the detailed description
During the preparation phase and at different points during the study, participants will complete several tests and questionnaires. These take about 30-60 minutes each.
These tests help the investigators:
Check whether participants are physically stable and safe enough to take part in the therapy sessions.
See how participants' physical and thinking abilities change over time.
During the appointments, participants will do exercises from:
Physiotherapy Occupational therapy And, if needed, speech therapy and language therapy Each therapy session lasts 30-45 minutes.
The exercises are a mix of:
Paper-based exercises Conversations and guided exercises with the therapists Exercises using apps that the participant downloads to his/her phone or tablet during the preparation phase (participants will receive instructions on how to use them)
Benefits and Risks Taking part in this study does not provide a direct personal benefit to the participant.
However, if this system proves to be successful, future patients may benefit from therapy that can be done from home.
There is a risk that the participant may not do the exercises at home with the same intensity as in the therapy clinic. However, since the participant will stay in regular contact with the therapists at home, we expect that this risk will have only a small effect on how well the therapy works.
Another possible risk is that, without a therapist physically present, participants may lose your balance more easily at home, which could lead to a fall and injury.
Before the study begins, we will carry out several tests to make sure participants are able to safely participate in the different therapies. This helps reduce the risk that participants cannot perform the exercises properly at home or get injured from a fall.
Funding and Costs This study is organized and fully funded by Luzerner Kantonsspital. The researchers involved do not receive any direct financial benefit from conducting this study.
Participants will not receive any payment or other compensation for participating.
There will be no additional costs for the participant or the health insurance upon participation.
- Conditions
- Stroke, Intracerebral Haemorrhage, Brain Trauma
- Being tested
- Blended care outpatient neurorehabilitation
- Keywords
- outpatient neurorehabilitation, Blended care/Telerehabilitation, Outcome
- Medical subject headings
- Stroke, Cerebral Hemorrhage, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blended care outpatient neurorehabilitationOther
Combination of telerehabilitation in the patients' home setting and outpatient neurorehabilitation on site
| Study group | Role | What they receive |
|---|---|---|
| Start with traditional outpatient neurorehabilitation, cross over to blended care after 3 weeks | Active comparator | traditional outpatient neurorehabilitation consists of a mean of 3 days of interdisciplinary therapies per week on site, blended care consists of 2 days of therapies in home setting and 1 day of therapies on site Receives: Other: Blended care outpatient neurorehabilitation |
| Start with blended care, cross over to traditional outpatient neurorehabilitation after 3 weeks | Experimental | Not described Receives: Other: Blended care outpatient neurorehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in total sum score between start and end of the 2 phases of the cross over periods on the Lucerne International Classification of Functioning, Disability and Health(ICF) -based Multidisciplinary Observation Scale (LIMOS)
Minimum Value: 45 Maximum Value: 225 Higher Scores mean better outcome
Measured: From start to end of the first crossover phase (Start of study - 3 weeks) and start to end of the second crossover phase (3 weeks - 6 weeks), follow-up at 3 months after end of the whole intervention phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start7 Apr 2026 (estimated)
- Primary completionMar 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luzerner Kantonsspital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noortje Maaijwee, Luzerner Kantonsspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07458308
- Sponsor's protocol ID
- Comparison of blended care
- Status last verified
- Apr 2026
- First submitted
- 3 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not planned, can be provided upon request
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Blended Care Outpatient Neurorehabilitation With Traditional Outpatient Neurorehabilitation, a Crossover Pilot Study
- ClinicalTrials.gov ID
- NCT07458308
- Acronym / sponsor ID
- Comparison of blended care
- Conditions
- Stroke, Intracerebral Haemorrhage, Brain Trauma
- Keywords
- outpatient neurorehabilitation, Blended care/Telerehabilitation, Outcome
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Luzerner KantonsspitalUniversity, hospital or other
- Study start
- 7 Apr 2026 (estimated)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 9 Mar 2026 (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.
What is this study about? Outpatient neurorehabilitation (therapy after leaving the hospital) is an important follow-up treatment for people who have had a stroke, brain bleeding, or serious head injury. It helps improve problems with movement, speech, memory, or daily activities.
At the same time, there are not enough healthcare professionals, and healthcare costs are rising. Because of this, we need new and more efficient ways to provide therapy.
One possible solution is telerehabilitation. This means patients do part of their therapy at home using video calls and apps. Early studies show that this can work well. However, in Switzerland it is still rarely used. One reason is that digital therapies are often not paid for, and there is still limited scientific proof of how effective they are.
In this study, the investigators want to find out how well a combination of traditional in-person therapy and digital therapy at home works. The goal is to make treatment more modern, effective, and affordable - benefiting patients, therapists, and the healthcare system.
How is the study organized?
Participants in the study are randomly divided into two groups.
Group 1:
First, participants have three weeks of combined therapy:
- therapy day per week at the hospital.
- therapy days per week at home via Microsoft Teams video calls. On home days, participants also complete exercises using apps provided by their therapists.
After that, participants have three weeks of therapy fully at the hospital (3 days per week).
Group 2:
First, participants have three weeks of therapy at the hospital (3 days per week).
After that, participants have three weeks of combined therapy (hospital + home video therapy).
Both groups receive the same types of therapy, just in a different order. This is called a crossover design.
Because this is one of the first studies of its kind, the investigators are starting with a small number of participants. This is called a pilot study.
Detailed description
During the preparation phase and at different points during the study, participants will complete several tests and questionnaires. These take about 30-60 minutes each.
These tests help the investigators:
Check whether participants are physically stable and safe enough to take part in the therapy sessions.
See how participants' physical and thinking abilities change over time.
During the appointments, participants will do exercises from:
Physiotherapy Occupational therapy And, if needed, speech therapy and language therapy Each therapy session lasts 30-45 minutes.
The exercises are a mix of:
Paper-based exercises Conversations and guided exercises with the therapists Exercises using apps that the participant downloads to his/her phone or tablet during the preparation phase (participants will receive instructions on how to use them)
Benefits and Risks Taking part in this study does not provide a direct personal benefit to the participant.
However, if this system proves to be successful, future patients may benefit from therapy that can be done from home.
There is a risk that the participant may not do the exercises at home with the same intensity as in the therapy clinic. However, since the participant will stay in regular contact with the therapists at home, we expect that this risk will have only a small effect on how well the therapy works.
Another possible risk is that, without a therapist physically present, participants may lose your balance more easily at home, which could lead to a fall and injury.
Before the study begins, we will carry out several tests to make sure participants are able to safely participate in the different therapies. This helps reduce the risk that participants cannot perform the exercises properly at home or get injured from a fall.
Funding and Costs This study is organized and fully funded by Luzerner Kantonsspital. The researchers involved do not receive any direct financial benefit from conducting this study.
Participants will not receive any payment or other compensation for participating.
There will be no additional costs for the participant or the health insurance upon participation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Start with traditional outpatient neurorehabilitation, cross over to blended care after 3 weeks | Active comparator | Other: Blended care outpatient neurorehabilitationtraditional outpatient neurorehabilitation consists of a mean of 3 days of interdisciplinary therapies per week on site, blended care consists of 2 days of therapies in home setting and 1 day of therapies on site |
| Start with blended care, cross over to traditional outpatient neurorehabilitation after 3 weeks | Experimental | Other: Blended care outpatient neurorehabilitation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of ischemic or haemorragic stroke or brain trauma.
- People for whom at least 6 weeks of outpatient rehabilitation is foreseen to be indicated.
- Ability for safe independent mobilisation (screening with MiniBesTest, Chedoke)
- Access to and ability to operate MS Teams and Apps on computer and other digital devices (Smartphone, Tablet) (Screening with AST, LAST and NHPT)
- Able to provide informed consent in German.
Key exclusion criteria (3 listed)
- Severe cardiopulmonary disease
- Other neurological disease than mentioned in the inclusion criteria
- Inability to provide 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 |
|---|---|---|
| Blended care outpatient neurorehabilitationCombination of telerehabilitation in the patients' home setting and outpatient neurorehabilitation on site | Other | Start with blended care, cross over to traditional outpatient neurorehabilitation after 3 weeks, Start with traditional outpatient neurorehabilitation, cross over to blended care after 3 weeks |
Primary outcome
The change in total sum score between start and end of the 2 phases of the cross over periods on the Lucerne International Classification of Functioning, Disability and Health(ICF) -based Multidisciplinary Observation Scale (LIMOS)
Time frame: From start to end of the first crossover phase (Start of study - 3 weeks) and start to end of the second crossover phase (3 weeks - 6 weeks), follow-up at 3 months after end of the whole intervention phase
Minimum Value: 45 Maximum Value: 225 Higher Scores mean better outcome
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Undecided. Not planned, can be provided upon request
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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.
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 Blended care outpatient neurorehabilitation in people with Stroke and Intracerebral Haemorrhage, run by Luzerner Kantonsspital at 1 site in Switzerland.
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 6 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: enrolling by invitation, as of the sponsor's last update on 13 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 Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
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?
The change in total sum score between start and end of the 2 phases of the cross over periods on the Lucerne International Classification of Functioning, Disability and Health(ICF) -based Multidisciplinary Observation Scale (LIMOS) (time frame: From start to end of the first crossover phase (Start of study - 3 weeks) and start to end of the second crossover phase (3 weeks - 6 weeks), follow-up at 3 months after end of the whole intervention phase). 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 13 Apr 2026.