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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Post-Viral Fatigue Syndrome
• Intervention / Treatment: Device: Robot rehabilitation

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katarzyna Hojan, MD, PhD; Phone Number: +48618546573; Email: khojan@ump.edu.pl
• Study Contact Backup: Name: Slawomir Tobis, PhD; Phone Number: +48618546573; Email: stobis@ump.edu.pl

Study Locations

• Poland
  • Poznań, Poland, 60-781
    • Recruiting
    • Poznan University of Medical Sciences
    • Contact: Katarzyna Hojan, MD, PhD; Phone Number: +48618546573; Email: khojan@ump.edu.pl
    • Contact: Slawomir Tobis, PhD; Phone Number: +48618546573; Email: stobis@ump.edu.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Poznan University of Medical Sciences
• Collaborators: EGZOTech sp. z o.o.; Szpital Wojewódzki w Poznaniu
• Investigators: Study Chair: Katarzyna Hojan, MD, PhD, Poznan University of Medical Sciences

Publications and helpful links

General Publications

• Zasadzka E, Tobis S, Trzmiel T, Marchewka R, Kozak D, Roksela A, Pieczynska A, Hojan K. Application of an EMG-Rehabilitation Robot in Patients with Post-Coronavirus Fatigue Syndrome (COVID-19)-A Feasibility Study. Int J Environ Res Public Health. 2022 Aug 20;19(16):10398. doi: 10.3390/ijerph191610398.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Anticipated): July 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: September 3, 2021
• First Submitted That Met QC Criteria: November 19, 2021
• First Posted (Actual): November 23, 2021

Study Record Updates

• Last Update Posted (Actual): November 23, 2021
• Last Update Submitted That Met QC Criteria: November 19, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Virus Diseases; Infections; Disease; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Encephalomyelitis; Syndrome; Fatigue; Fatigue Syndrome, Chronic
• Other Study ID Numbers: 514/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No