跳至主要内容
临床试验/NCT07458308
NCT07458308Enrolling By Invitation不适用

Comparison of Blended Care Outpatient Neurorehabilitation With Traditional Outpatient Neurorehabilitation, a Crossover Pilot Study

Luzerner Kantonsspital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年4月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
30
试验地点
1
主要终点
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)

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

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

Experimental

干预措施: Blended care outpatient neurorehabilitation (Other)

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

干预措施: Blended care outpatient neurorehabilitation (Other)

结局指标

主要结局

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)

时间窗: 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

The change in total sum score between start and end of the 2 phases of the cross over periods on the Lucerne ICF-based Multidisciplinary Observation Scale (LIMOS)

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Noortje Maaijwee

MD, PhD

Luzerner Kantonsspital

研究点 (1)

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