Clinical trial NCT03641651: New Technologies in the Rehabilitation of Chronic Stroke
Official title: Feasibility and Cost Description of Intensive Rehabilitation Involving New Technologies in Patients With Sub-acute Stroke:A Multicenter Single Arm Trial of the Swiss RehabTech Initiative
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Hemiplegia
Lead sponsor: Zurich University of Applied Sciences
Sponsor class: OTHER
Collaborators: name: Klinik Lengg, Zurich
name: Reha Rheinfelden
name: Klinik Valens
name: Rehaklinik Zihlschlacht AG
First posted: 2018-08-22
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The objective of the current study is to develop and investigate training concepts involving rehabilitation technology, which aim at exploiting the potential for regaining the ability to perform skilled movements by maximizing training intensity and keeping the motivation of patients high.

The evaluation focuses on feasibility and cost-benefit analyses

Detailed description: This feasibility project aims to establish an efficient setting for intensive rehabilitation with new technology in four trailblazer clinics. This will enable them to provide intensive therapy to the patients in accordance with the study protocol. If this setting is integrated into the clinical routine, the investigators will be able to collect data to get some first insight into economic and functional data required to calculate changes in socioeconomic costs

Eligibility criteria: Inclusion Criteria:

* Adult patients with residual hemiparesis after cerebrovascular accident
* Up to 12 months after the event
* Primary rehabilitation terminated
* Able to cognitively comprehend the aim of the project with at least 22 points in the Montreal Cognitive Assessment (MoCA)
* General health condition allows for intensive rehabilitative training with limited supervision i.e. clearance and prescription of responsible physician
* Understand written and spoken German language

Exclusion Criteria:

Patients with any signs and symptoms showing that the participant is unwilling to participate in the study will result in the patient being excluded from participation Any medical condition preventing participation such as Severe respiratory disease Severe OR unstable cardio-circulatory conditions Orthopaedic conditions, especially in extremities targeted for rehabilitation such as

* fixed joint contractures limiting range of motion
* non-consolidated fractures Neuro-psychological conditions including cognitive deficits limiting communication or non-cooperation like (self-) aggressive behaviour Infections or inflammatory diseases, like osteomyelitis

Specific absolute contraindication for the training with any of the respective devices:

* Improper fit of the device, including its harness to relevant extremity(ies)
* Contraindicated training position (standing, sitting)

Device specific contraindications will be respected and will lead to the exclusion of the device for that patient.

Primary outcomes:
measure: Correlation Between Scheduled and Performed Trainings
timeFrame: 4 weeks
Secondary outcomes:
measure: Functional Independence Measurement (FIM) Generic Functional Performance
timeFrame: Baseline and 4 weeks
measure: Stroke Impact Scale (SIS) Recovery
timeFrame: Baseline and 4 weeks
measure: Box and Block Test
timeFrame: Baseline and 4 weeks
measure: Functional Ambulation Categories (FAC)
timeFrame: Baseline and 4 weeks
measure: 10m Walk Test= TMT Comfortable
timeFrame: Baseline and 4 weeks
measure: Walking Index of the Chedoke-McMaster Stroke Assessment Measure (CMSA)
timeFrame: Baseline and 4 weeks
measure: Berg Balance Scale (BBS)
timeFrame: Baseline and 4 weeks
Other outcomes:
Locations:
city: Rheinfelden
country: Switzerland
facility: Reha Rheinfelden
city: Valens
country: Switzerland
facility: Kliniken Valens
city: Zihlschlacht
country: Switzerland
facility: Rehakliniken Zihlschlacht
city: Zürich
country: Switzerland
facility: Klinik Lengg AG
Study officials:
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