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

Post-Viral Fatigue Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05130736
• Other study ID #: 514/21
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2021
• Source: Poznan University of Medical Sciences
• Contact: Katarzyna Hojan, MD, PhD
• Phone: +48618546573
• Email: khojan[@]ump.edu.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Fatigue Syndrome, Chronic
• Post-Viral Fatigue Syndrome
• Syndrome

Intervention

Device:
• Robot rehabilitation
Effectiveness of using a rehabilitation robot in post-COVID-19 rehabilitation

Locations

Country	Name	City	State
Poland	Poznan University of Medical Sciences	Poznan

Sponsors (3)

Lead Sponsor	Collaborator
Poznan University of Medical Sciences	EGZOTech sp. z o.o., Szpital Wojewódzki w Poznaniu

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in isokinetic muscle force	Raw robot measurement data (5 repetitions during measurement with LUNA)	Baseline, after 3 and after 8 weeks
Secondary	Change in functional physical ability 1	Functional Independence Measure	Baseline, after 3 and after 8 weeks
Secondary	Change in functional physical ability 2	Barthel Index	Baseline, after 3 and after 8 weeks
Secondary	Change in functional physical ability 3	Berg Balance Test	Baseline, after 3 and after 8 weeks
Secondary	Change in functional physical ability 4	Short Physical Performance Battery	Baseline, after 3 and after 8 weeks
Secondary	Change in cognitive ability 1	Addenbrooke's Cognitive Examination (ACE-III)	Baseline, after 3 and after 8 weeks
Secondary	Change in cognitive ability 2	Montreal Cognitive Assessment	Baseline, after 3 and after 8 weeks
Secondary	Change in the quality of life	WHOQOL	Baseline, after 3 and after 8 weeks
Secondary	Change in depressive symptoms	Beck's Depression Inventory	Baseline, after 3 and after 8 weeks