Improving the Quality of Life of Stroke Patients Using the Armeo Spring Device
- Conditions
- Ischemic Stroke
- Interventions
- Procedure: Armeo Spring physiotherapyProcedure: Standard physiotherapy
- Registration Number
- NCT05743413
- Lead Sponsor
- University Hospital Ostrava
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Armeo Spring Armeo Spring physiotherapy Study subjects randomized into this group will undergo physiotherapy sessions using the Armeo Spring device. Standard physiotherapy Standard physiotherapy Study subjects randomized into this control group will undergo standard physiotherapy sessions.
- Primary Outcome Measures
Name Time Method Change of upper extremity function - variability 3 weeks Variability represents the standard deviation of the points on the track from their average coordinates and is therefore a value of accuracy on target. The value describes the patient's ability to maintain a steady position. Maintaining a perfectly stable position has a variability value of 0. A variability of 2 cm means that 68% of the points on the track are within 2 cm.
Quality of Life - EQ-5D 3 weeks These are standardized questionnaires, i.e. providing exact results of measuring the quality of life in various domains of health status. The EQ-5D group of questionnaires is used worldwide and is one of the most widely used scales in healthcare. It has been certified and translated into many languages. Its use is validated by recent meta-analyses. The questionnaires monitor a total of 5 domains of quality of life - mobility, self-care, normal activities, pain, discomfort, anxiety and depression.
Change of upper extremity function - HPR 3 weeks The HPR value (hand path ratio) is used to evaluate the quality of the patient's movement. It is calculated by dividing the length of the path of the patient's hand by the distance between the points to be grasped in the exercises. A perfectly straight movement has an HPR value of 1. An HPR value of 2 means that the path length of the patient's hand was twice as long as the shortest line connecting the points.
Change of upper extremity function - A GOAL 3 weeks Exercise A Goal is an assessment exercise that aims to evaluate the accuracy of the patient's gross motor movements. After placing the pointer on the base, the target will appear. The patient must try to catch the target in a perfectly linear motion and then stay exactly in the center of the target for 3 seconds.
Change of upper extremity function - deviation 3 weeks The deviation shows the distance of the pointer to the center point of the target s, so it is the accuracy value on the target. The value describes the patient's ability to meet positional accuracy. A perfect match between the indicator and the resulting target position represents a deviation value of 0. A deviation value of 2 means that the patient missed the target position by 2 cm.
- Secondary Outcome Measures
Name Time Method Modified Frenchay Scale (MFS) test 3 weeks The Modified Frenchay Scale (MFS) measures active upper limb function in hemiparesis based on a video review of 10 everyday living tasks, each rated on a 10-point visual analogic scale. Six tasks are bimanual and four are unimanual performed with the paretic hand.
The Barthel Index (BI) 3 weeks The Barthel Index (BI) measures the extent to which somebody can function independently and has mobility in their activities of daily living (ADL) i.e. feeding, bathing, grooming, dressing, bowel control, bladder control, toileting, chair transfer, ambulation and stair climbing.
Trial Locations
- Locations (1)
University Hospital Ostrava
🇨🇿Ostrava, Moravian-Silesian Region, Czechia