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

University Hospital Ostrava

Status: Enrolling

Conditions: Ischemic Stroke

Treatments: Procedure: Armeo Spring physiotherapy; Procedure: Standard physiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05743413

FNO-KRTL-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Armeo Spring

Experimental group

Description:

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

Treatment:

Procedure: Armeo Spring physiotherapy

Standard physiotherapy

Active Comparator group

Description:

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

Treatment:

Procedure: Standard physiotherapy