Improving the Quality of Life of Stroke Patients Using the Armeo Spring Device
NCT ID: NCT05743413
Last Updated: 2023-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
10 participants
INTERVENTIONAL
2022-11-01
2023-10-31
Brief Summary
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The secondary outcome will be to evaluate changes in self-sufficiency using a test of daily activities modified by the Frenchay test of daily activities.
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Detailed Description
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A prospective monocentric randomized study lasting 8 months at the Department of Rehabilitation and Sports Medicine, University Hospital Ostrava. The study design is parallel with a test and control arm. Patients will be divided into an intervention (tested) group A with therapy on Armeo Spring and a control group B with conventional therapy, using a random number generator, where odd numbers represent arm A and even numbers represent arm B. A randomization table randomly allocates patients to therapy according to their order of entry into the study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Armeo Spring
Study subjects randomized into this group will undergo physiotherapy sessions using the Armeo Spring device.
Armeo Spring physiotherapy
Study subjects will undergo physiotherapy sessions using the Armeo Spring device.
Standard physiotherapy
Study subjects randomized into this control group will undergo standard physiotherapy sessions.
Standard physiotherapy
Study subjects will undergo standard physiotherapy sessions.
Interventions
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Armeo Spring physiotherapy
Study subjects will undergo physiotherapy sessions using the Armeo Spring device.
Standard physiotherapy
Study subjects will undergo standard physiotherapy sessions.
Eligibility Criteria
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Inclusion Criteria
* age over 18 years
* Modified Rankin Scale (mRS) of 2-3
* moderate paresis of the upper extremity (individuals with shoulder/elbow muscle test values in the range of 3-1)
* cardiovascular stability
Exclusion Criteria
* severe cognitive or sensory deficit and non-cooperation
* severe osteoporosis
* impaired skin integrity in the trunk and upper limbs
* cardiovascular instability
* unstable fractures
* acute inflammatory diseases
18 Years
85 Years
ALL
No
Sponsors
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University of Ostrava
OTHER
University Hospital Ostrava
OTHER
Responsible Party
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Principal Investigators
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Šárka Anežka Čechová, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Ostrava
Locations
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University Hospital Ostrava
Ostrava, Moravian-Silesian Region, Czechia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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FNO-KRTL-01
Identifier Type: -
Identifier Source: org_study_id
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