NCT07458308

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
34mo left

Started Apr 2026

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress10%
Apr 2026Jun 2029

First Submitted

Initial submission to the registry

March 3, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 9, 2026

Completed
29 days until next milestone

Study Start

First participant enrolled

April 7, 2026

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2029

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2029

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

2.9 years

First QC Date

March 3, 2026

Last Update Submit

April 7, 2026

Conditions

Keywords

outpatient neurorehabilitationBlended care/TelerehabilitationOutcome

Outcome Measures

Primary Outcomes (1)

  • 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

    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

Study Arms (2)

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

Other: Blended care outpatient neurorehabilitation

Start with blended care, cross over to traditional outpatient neurorehabilitation after 3 weeks

EXPERIMENTAL
Other: Blended care outpatient neurorehabilitation

Interventions

Combination of telerehabilitation in the patients' home setting and outpatient neurorehabilitation on site

Start with blended care, cross over to traditional outpatient neurorehabilitation after 3 weeksStart with traditional outpatient neurorehabilitation, cross over to blended care after 3 weeks

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Severe cardiopulmonary disease
  • Inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Luzerner Kantonsspital

Lucerne, Switzerland

Location

MeSH Terms

Conditions

StrokeCerebral HemorrhageBrain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesIntracranial HemorrhagesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsBrain InjuriesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

March 3, 2026

First Posted

March 9, 2026

Study Start

April 7, 2026

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

June 1, 2029

Last Updated

April 13, 2026

Record last verified: 2026-04

Locations