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

Not Applicable

• Conditions: Post-Viral Fatigue Syndrome
• Interventions: Device: Robot rehabilitation

• Registration Number: NCT05130736
• Lead Sponsor: Poznan University of Medical Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-01
• Study First Submitted: 2021-09-03
• Status Verified: 2021-11
• Study First Submitted QC: 2021-11-19
• Last Update Submitted: 2021-11-19
• Study First Posted: 2021-11-23
• Last Update Posted: 2021-11-23
• Primary Completion: 2022-07-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Robot rehabilitation	Patients receiving traditional rehabilitation treatment (robot used only as assessment tool)
Robot	Robot rehabilitation	Patients treated using a rehabilitation robot

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Poznan University of Medical Sciences; 🇵🇱 Poznań, Poland