Rehabilitation Robot in Patients With Post-Coronavirus Disease (COVID-19) Fatigue Syndrome

Poznan University of Medical Sciences (PUMS)

Status: Unknown

Conditions: Post-Viral Fatigue Syndrome

Treatments: Device: Robot rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT05130736

514/21

Details and patient eligibility

About

The aim of the study is to compare the effectiveness of two models of rehabilitation:

• traditional neurological rehabilitation, and
• neurological rehabilitation combined with a rehabilitation robot (Luna by EGZOTech).

An additional goal is to test the qualitative diagnostic reference using the surface electromyogram of the Luna robot (certified as a Medical Device) for functional diagnostics based on standardized clinical tests.

Enrollment: 80 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients discharged from Intensive Care Units after undergone ventilator therapy due to COVID-19

Exclusion criteria

• active medical condition (infections; tumors; rheumatological, metabolic, endocrine, autoimmunological, cardiovascular diseases)
• bipolar disorder
• dementia
• nutritional disorders
• addiction to alcohol or psychoactive substances
• severe obesity
• overtraining

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Robot

Experimental group

Description:

Patients treated using a rehabilitation robot

Treatment:

Device: Robot rehabilitation

Control

Active Comparator group

Description:

Patients receiving traditional rehabilitation treatment (robot used only as assessment tool)

Treatment:

Device: Robot rehabilitation