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

Study Overview
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Brief Summary
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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.

Official Title
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The Use of a Rehabilitation Robot in Patients With Post-COVID-19 Fatigue Syndrome

Conditions
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Post-Viral Fatigue Syndrome

Intervention / Treatment
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* Device: Robot rehabilitation


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robot<br>Patients treated using a rehabilitation robot | Device: Robot rehabilitation<br>* Effectiveness of using a rehabilitation robot in post-COVID-19 rehabilitation<br>|
| Active Comparator: Control<br>Patients receiving traditional rehabilitation treatment (robot used only as assessment tool) | Device: Robot rehabilitation<br>* Effectiveness of using a rehabilitation robot in post-COVID-19 rehabilitation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in muscle fatigue assessment | Raw robot measurement data (isometric contraction of the muscle for 60 s - biceps, quadriceps) | Baseline, after 3 and after 8 weeks | 
| Change in isokinetic muscle force | Raw robot measurement data (5 repetitions during measurement with LUNA) | Baseline, after 3 and after 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in functional physical ability 1 | Functional Independence Measure | Baseline, after 3 and after 8 weeks | 
| Change in functional physical ability 2 | Barthel Index | Baseline, after 3 and after 8 weeks | 
| Change in functional physical ability 3 | Berg Balance Test | Baseline, after 3 and after 8 weeks | 
| Change in functional physical ability 4 | Short Physical Performance Battery | Baseline, after 3 and after 8 weeks | 
| Change in cognitive ability 1 | Addenbrooke's Cognitive Examination (ACE-III) | Baseline, after 3 and after 8 weeks | 
| Change in cognitive ability 2 | Montreal Cognitive Assessment | Baseline, after 3 and after 8 weeks | 
| Change in the quality of life | WHOQOL | Baseline, after 3 and after 8 weeks | 
| Change in depressive symptoms | Beck's Depression Inventory | Baseline, after 3 and after 8 weeks |