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

June 19, 2023 updated by: University Hospital Ostrava

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Czechia
    • Moravian-Silesian Region
      • Ostrava, Moravian-Silesian Region, Czechia, 70852
        • Recruiting
        • University Hospital Ostrava
        • Contact:
        • Sub-Investigator:
          • Tomáš Hudeček, MD
        • Principal Investigator:
          • Šárka Anežka Čechová, MD
        • Sub-Investigator:
          • Šárka Baníková, MD,MBA
        • Sub-Investigator:
          • Kamila Slezáková, MD
        • Sub-Investigator:
          • Michal Krajňák, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Armeo Spring
Study subjects randomized into this group will undergo physiotherapy sessions using the Armeo Spring device.
Procedure: Armeo Spring physiotherapy
Study subjects will undergo physiotherapy sessions using the Armeo Spring device.
Active Comparator: Standard physiotherapy
Study subjects randomized into this control group will undergo standard physiotherapy sessions.
Procedure: Standard physiotherapy
Study subjects will undergo standard physiotherapy sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 weeks
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.
3 weeks
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.
3 weeks
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.
3 weeks
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.
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Frenchay Scale (MFS) test
Time Frame: 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.
3 weeks
The Barthel Index (BI)
Time Frame: 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.
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Ostrava

Collaborators

University of Ostrava

Investigators

  • Principal Investigator: Šárka Anežka Čechová, MD, University Hospital Ostrava

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Estimated)

August 31, 2023

Study Completion (Estimated)

October 31, 2023

Study Registration Dates

First Submitted

February 14, 2023

First Submitted That Met QC Criteria

February 14, 2023

First Posted (Actual)

February 24, 2023

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 19, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FNO-KRTL-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make individual participant data available to other researchers. The data may be provided upon request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ischemic Stroke

Clinical Trials on Armeo Spring physiotherapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Moldova

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe