Ischemic StrokeNCT05743413
Improving the Quality of Life of Stroke Patients Using the Armeo Spring Device
A study testing Armeo Spring physiotherapy and Standard physiotherapy in people with Ischemic Stroke, run by University Hospital Ostrava at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Armeo Spring physiotherapy and Standard physiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Nov 2022to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 70852
Jiří Hynčica, 0042059737 ext. 2587, jiri.hyncica@fno.cz
Šárka Anežka Čechová, MD
About this study
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
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.
Read the 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.
- Conditions
- Ischemic Stroke
- Being tested
- Armeo Spring physiotherapy, Standard physiotherapy
- Keywords
- ischemic stroke, rehabilitation, Armeo Spring therapy, quality of life
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Armeo Spring physiotherapyProcedure or surgery
Study subjects will undergo physiotherapy sessions using the Armeo Spring device.
Standard physiotherapyProcedure or surgery
Study subjects will undergo standard physiotherapy sessions.
| Study group | Role | What they receive |
|---|---|---|
| Armeo Spring | Experimental | Study subjects randomized into this group will undergo physiotherapy sessions using the Armeo Spring device. Receives: Procedure: Armeo Spring physiotherapy |
| Standard physiotherapy | Active comparator | Study subjects randomized into this control group will undergo standard physiotherapy sessions. Receives: Procedure: Standard physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 weeks
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.
Measured: 3 weeks
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.
Measured: 3 weeks
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.
Measured: 3 weeks
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.
Measured: 3 weeks
Secondary outcomes (2)
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.
Measured: 3 weeks
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.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start1 Nov 2022
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study participants will be enrolled into two parallel groups.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ostrava
- Responsible party
- Sponsor
- Investigators
- Šárka Anežka Čechová, MD, Principal investigator, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05743413
- Sponsor's protocol ID
- FNO-KRTL-01
- Status last verified
- Jun 2023
- First submitted
- 14 Feb 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers. The data may be provided upon request.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05743413
- Acronym / sponsor ID
- FNO-KRTL-01
- Conditions
- Ischemic Stroke
- Keywords
- ischemic stroke, rehabilitation, Armeo Spring therapy, quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Collaborators
- University of Ostrava
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 24 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study participants will be enrolled into two parallel groups.
| Arm | Type | Receives |
|---|---|---|
| Armeo Spring | Experimental | Procedure: Armeo Spring physiotherapyStudy subjects randomized into this group will undergo physiotherapy sessions using the Armeo Spring device. |
| Standard physiotherapy | Active comparator | Procedure: Standard physiotherapyStudy subjects randomized into this control group will undergo standard physiotherapy sessions. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Armeo Spring physiotherapyStudy subjects will undergo physiotherapy sessions using the Armeo Spring device. | Procedure or surgery | Armeo Spring |
| Standard physiotherapyStudy subjects will undergo standard physiotherapy sessions. | Procedure or surgery | Standard physiotherapy |
Primary outcome
Change of upper extremity function - A GOAL
Time frame: 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 - HPR
Time frame: 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 - deviation
Time frame: 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.
Change of upper extremity function - variability
Time frame: 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
Time frame: 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.
2 secondary outcomes
Modified Frenchay Scale (MFS) test
Time frame: 3 weeks
The Barthel Index (BI)
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers. The data may be provided upon request.
Related trials for Ischemic Stroke
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Šárka Anežka Čechová, MD principal investigator
University Hospital Ostrava
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Armeo Spring physiotherapy and Standard physiotherapy in people with Ischemic Stroke, run by University Hospital Ostrava at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiří Hynčica (0042059737 ext. 2587, jiri.hyncica@fno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of upper extremity function - A GOAL (time frame: 3 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.