Comparison of Blended Care Outpatient Neurorehabilitation With Traditional Outpatient Neurorehabilitation

April 7, 2026 updated by: Noortje Maaijwee, Luzerner Kantonsspital

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.

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:

  1. therapy day per week at the hospital.
  2. 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Switzerland
      • Lucerne, Switzerland
        • Luzerner Kantonsspital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Severe cardiopulmonary disease
  • Other neurological disease than mentioned in the inclusion criteria
  • Inability to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Start with traditional outpatient neurorehabilitation, cross over to blended care after 3 weeks
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
Other: Blended care outpatient neurorehabilitation
Combination of telerehabilitation in the patients' home setting and outpatient neurorehabilitation on site
Experimental: Start with blended care, cross over to traditional outpatient neurorehabilitation after 3 weeks
Other: Blended care outpatient neurorehabilitation
Combination of telerehabilitation in the patients' home setting and outpatient neurorehabilitation on site

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Luzerner Kantonsspital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 7, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Comparison of blended care

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Not planned, can be provided upon request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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