search
Back to results

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

Primary Purpose

Ischemic Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Armeo Spring physiotherapy
Standard physiotherapy
Sponsored by
University Hospital Ostrava
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring ischemic stroke, rehabilitation, Armeo Spring therapy, quality of life

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital OstravaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Armeo Spring

Standard physiotherapy

Arm Description

Study subjects randomized into this group will undergo physiotherapy sessions using the Armeo Spring device.

Study subjects randomized into this control group will undergo standard physiotherapy sessions.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
February 14, 2023
Last Updated
June 19, 2023
Sponsor
University Hospital Ostrava
Collaborators
University of Ostrava
search

1. Study Identification

Unique Protocol Identification Number
NCT05743413
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Ostrava
Collaborators
University of Ostrava

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
ischemic stroke, rehabilitation, Armeo Spring therapy, quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study participants will be enrolled into two parallel groups.
Masking
None (Open Label)
Masking Description
No masking will be used in the study.
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Armeo Spring
Arm Type
Experimental
Arm Description
Study subjects randomized into this group will undergo physiotherapy sessions using the Armeo Spring device.
Arm Title
Standard physiotherapy
Arm Type
Active Comparator
Arm Description
Study subjects randomized into this control group will undergo standard physiotherapy sessions.
Intervention Type
Procedure
Intervention Name(s)
Armeo Spring physiotherapy
Intervention Description
Study subjects will undergo physiotherapy sessions using the Armeo Spring device.
Intervention Type
Procedure
Intervention Name(s)
Standard physiotherapy
Intervention Description
Study subjects will undergo standard physiotherapy sessions.
Primary Outcome Measure Information:
Title
Change of upper extremity function - A GOAL
Description
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.
Time Frame
3 weeks
Title
Change of upper extremity function - HPR
Description
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.
Time Frame
3 weeks
Title
Change of upper extremity function - deviation
Description
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.
Time Frame
3 weeks
Title
Change of upper extremity function - variability
Description
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.
Time Frame
3 weeks
Title
Quality of Life - EQ-5D
Description
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.
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Modified Frenchay Scale (MFS) test
Description
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.
Time Frame
3 weeks
Title
The Barthel Index (BI)
Description
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.
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiří Hynčica
Phone
0042059737
Ext
2587
Email
jiri.hyncica@fno.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Šárka Anežka Čechová, MD
Organizational Affiliation
University Hospital Ostrava
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ostrava
City
Ostrava
State/Province
Moravian-Silesian Region
ZIP/Postal Code
70852
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiří Hynčica
Phone
0042059737
Ext
2587
Email
jiri.hyncica@fno.cz
First Name & Middle Initial & Last Name & Degree
Šárka Anežka Čechová, MD
First Name & Middle Initial & Last Name & Degree
Šárka Baníková, MD,MBA
First Name & Middle Initial & Last Name & Degree
Kamila Slezáková, MD
First Name & Middle Initial & Last Name & Degree
Tomáš Hudeček, MD
First Name & Middle Initial & Last Name & Degree
Michal Krajňák, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make individual participant data available to other researchers. The data may be provided upon request.

Learn more about this trial

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

We'll reach out to this number within 24 hrs