Clinical trial NCT05743413: Improving the Quality of Life of Stroke Patients Using the Armeo Spring Device
Official title: Evaluation of the Effect of Rehabilitation Using the Armeo Spring Device on Improving the Quality of Motion of Upper Extremity in Patients in the Sub-acute Stage After Stroke and Its Correlation With the Rate of Improvement in the Quality of Life After Completing Rehabilitation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ischemic Stroke
Keywords: ischemic stroke
rehabilitation
Armeo Spring therapy
quality of life
Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
Collaborators: name: University of Ostrava
First posted: 2023-02-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study participants will be enrolled into two parallel groups.
Primary purpose: TREATMENT

Brief summary: The main goal will be to evaluate the effect of improving the quality of movement of the upper limb (using an evaluation exercise in the software of the Armeo Spring device) on the development of the quality of life after stroke using a standardized generic and specific questionnaire.

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.

Detailed description: The research follows on from a pilot study that took place at the Department of Rehabilitation and Sports Medicine, University Hospital Ostrava from 4/2022 to 9/2022. It has a prospective monocentric randomized trial design. Patients will be randomized into parallel groups - intervention and control groups.

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.

Eligibility criteria: Inclusion Criteria:

* history of stroke
* 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:

* age under 18 years
* 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

Primary outcomes:
measure: Change of upper extremity function - A GOAL
timeFrame: 3 weeks
measure: Change of upper extremity function - HPR
timeFrame: 3 weeks
measure: Change of upper extremity function - deviation
timeFrame: 3 weeks
measure: Change of upper extremity function - variability
timeFrame: 3 weeks
measure: Quality of Life - EQ-5D
timeFrame: 3 weeks
Secondary outcomes:
measure: Modified Frenchay Scale (MFS) test
timeFrame: 3 weeks
measure: The Barthel Index (BI)
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
state: Moravian-Silesian Region
Study officials:
affiliation: University Hospital Ostrava
name: Šárka Anežka Čechová, MD
role: PRINCIPAL_INVESTIGATOR
References: