Clinical Trials Directory

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UnknownNCT05743413

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

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
10 (estimated)
Sponsor
University Hospital Ostrava · Academic / Other
Sex
All
Age
18 Years – 85 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREArmeo Spring physiotherapyStudy subjects will undergo physiotherapy sessions using the Armeo Spring device.
PROCEDUREStandard physiotherapyStudy subjects will undergo standard physiotherapy sessions.

Timeline

Start date
2022-11-01
Primary completion
2023-08-31
Completion
2023-10-31
First posted
2023-02-24
Last updated
2023-06-22

Locations

1 site across 1 country: Czechia

Source: ClinicalTrials.gov record NCT05743413. Inclusion in this directory is not an endorsement.