- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07458308
Comparison of Blended Care Outpatient Neurorehabilitation With Traditional Outpatient Neurorehabilitation
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:
- 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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Lucerne, Switzerland
- Luzerner Kantonsspital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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 |
Intervention / Treatment |
|---|---|
|
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
|
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
|
Combination of telerehabilitation in the patients' home setting and outpatient neurorehabilitation on site
|
What is the study measuring?
Primary Outcome Measures
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
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Wounds and Injuries
- Pathologic Processes
- Hemorrhage
- Craniocerebral Trauma
- Trauma, Nervous System
- Intracranial Hemorrhages
- Brain Injuries
- Pathological Conditions, Signs and Symptoms
- Brain Injuries, Traumatic
- Stroke
- Cerebral Hemorrhage
Other Study ID Numbers
- Comparison of blended care
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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