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

NCT ID: NCT05743413

Last Updated: 2023-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2023-10-31

Brief Summary

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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

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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

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Ischemic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study participants will be enrolled into two parallel groups.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

No masking will be used in the study.

Study Groups

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Armeo Spring

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

Group Type EXPERIMENTAL

Armeo Spring physiotherapy

Intervention Type PROCEDURE

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

Standard physiotherapy

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

Group Type ACTIVE_COMPARATOR

Standard physiotherapy

Intervention Type PROCEDURE

Study subjects will undergo standard physiotherapy sessions.

Interventions

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Armeo Spring physiotherapy

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

Intervention Type PROCEDURE

Standard physiotherapy

Study subjects will undergo standard physiotherapy sessions.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Ostrava

OTHER

Sponsor Role collaborator

University Hospital Ostrava

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Šárka Anežka Čechová, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Ostrava

Locations

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University Hospital Ostrava

Ostrava, Moravian-Silesian Region, Czechia

Site Status RECRUITING

Countries

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Czechia

Central Contacts

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Jiří Hynčica

Role: CONTACT

0042059737 ext. 2587

Facility Contacts

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Jiří Hynčica

Role: primary

0042059737 ext. 2587

Other Identifiers

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FNO-KRTL-01

Identifier Type: -

Identifier Source: org_study_id

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