Improving the Quality of Life of Stroke Patients Using the Armeo Spring Device

Ischemic Stroke Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05743413
• Other study ID #: FNO-KRTL-01
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: October 31, 2023

Study information

• Verified date: June 2023
• Source: University Hospital Ostrava
• Contact: Jirí Hyncica
• Phone: 0042059737
• Email: jiri.hyncica[@]fno.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: October 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke

Intervention

Procedure:
• Armeo Spring physiotherapy
Study subjects will undergo physiotherapy sessions using the Armeo Spring device.
• Standard physiotherapy
Study subjects will undergo standard physiotherapy sessions.

Locations

Country	Name	City	State
Czechia	University Hospital Ostrava	Ostrava	Moravian-Silesian Region

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Ostrava	University of Ostrava

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of upper extremity function - A GOAL	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.	3 weeks
Primary	Change of upper extremity function - HPR	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.	3 weeks
Primary	Change of upper extremity function - deviation	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.	3 weeks
Primary	Change of upper extremity function - variability	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.	3 weeks
Primary	Quality of Life - EQ-5D	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.	3 weeks
Secondary	Modified Frenchay Scale (MFS) test	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.	3 weeks
Secondary	The Barthel Index (BI)	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.	3 weeks