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

NCT05743413 | Unknown

• 1 other identifier: FNO-KRTL-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke

Keywords

ischemic stroke; rehabilitation; Armeo Spring therapy; quality of life

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (2)

• Modified Frenchay Scale (MFS) test

  3 weeks

• The Barthel Index (BI)

  3 weeks

Study Arms (2)

Armeo Spring

EXPERIMENTAL

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

Procedure: Armeo Spring physiotherapy

Standard physiotherapy

ACTIVE COMPARATOR

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

Procedure: Standard physiotherapy

Interventions

Armeo Spring physiotherapy PROCEDURE

Study subjects will undergo physiotherapy sessions using the Armeo Spring device.

Armeo Spring

Standard physiotherapy PROCEDURE

Study subjects will undergo standard physiotherapy sessions.

Standard physiotherapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Ostrava: lead
• University of Ostrava: collaborator

Study Sites (1)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Šárka Anežka Čechová, MD

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiří Hynčica

CONTACT

0042059737; jiri.hyncica@fno.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking will be used in the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study participants will be enrolled into two parallel groups.

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: February 24, 2023
• Study Start: November 1, 2022
• Primary Completion: August 31, 2023
• Study Completion: October 31, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)