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

Primary Purpose

Post-Viral Fatigue Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Robot rehabilitation
Sponsored by
Poznan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Post-Viral Fatigue Syndrome

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Poznan University of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Robot

Control

Arm Description

Patients treated using a rehabilitation robot

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

Outcomes

Primary Outcome Measures

Change in muscle fatigue assessment
Raw robot measurement data (isometric contraction of the muscle for 60 s - biceps, quadriceps)
Change in isokinetic muscle force
Raw robot measurement data (5 repetitions during measurement with LUNA)

Secondary Outcome Measures

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

Full Information

First Posted
September 3, 2021
Last Updated
November 19, 2021
Sponsor
Poznan University of Medical Sciences
Collaborators
EGZOTech sp. z o.o., Szpital Wojewódzki w Poznaniu
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1. Study Identification

Unique Protocol Identification Number
NCT05130736
Brief Title
Rehabilitation Robot in Patients With Post-Coronavirus Disease (COVID-19) Fatigue Syndrome
Official Title
The Use of a Rehabilitation Robot in Patients With Post-COVID-19 Fatigue Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
July 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poznan University of Medical Sciences
Collaborators
EGZOTech sp. z o.o., Szpital Wojewódzki w Poznaniu

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Viral Fatigue Syndrome

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Robot
Arm Type
Experimental
Arm Description
Patients treated using a rehabilitation robot
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Patients receiving traditional rehabilitation treatment (robot used only as assessment tool)
Intervention Type
Device
Intervention Name(s)
Robot rehabilitation
Intervention Description
Effectiveness of using a rehabilitation robot in post-COVID-19 rehabilitation
Primary Outcome Measure Information:
Title
Change in muscle fatigue assessment
Description
Raw robot measurement data (isometric contraction of the muscle for 60 s - biceps, quadriceps)
Time Frame
Baseline, after 3 and after 8 weeks
Title
Change in isokinetic muscle force
Description
Raw robot measurement data (5 repetitions during measurement with LUNA)
Time Frame
Baseline, after 3 and after 8 weeks
Secondary Outcome Measure Information:
Title
Change in functional physical ability 1
Description
Functional Independence Measure
Time Frame
Baseline, after 3 and after 8 weeks
Title
Change in functional physical ability 2
Description
Barthel Index
Time Frame
Baseline, after 3 and after 8 weeks
Title
Change in functional physical ability 3
Description
Berg Balance Test
Time Frame
Baseline, after 3 and after 8 weeks
Title
Change in functional physical ability 4
Description
Short Physical Performance Battery
Time Frame
Baseline, after 3 and after 8 weeks
Title
Change in cognitive ability 1
Description
Addenbrooke's Cognitive Examination (ACE-III)
Time Frame
Baseline, after 3 and after 8 weeks
Title
Change in cognitive ability 2
Description
Montreal Cognitive Assessment
Time Frame
Baseline, after 3 and after 8 weeks
Title
Change in the quality of life
Description
WHOQOL
Time Frame
Baseline, after 3 and after 8 weeks
Title
Change in depressive symptoms
Description
Beck's Depression Inventory
Time Frame
Baseline, after 3 and after 8 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katarzyna Hojan, MD, PhD
Phone
+48618546573
Email
khojan@ump.edu.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Slawomir Tobis, PhD
Phone
+48618546573
Email
stobis@ump.edu.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katarzyna Hojan, MD, PhD
Organizational Affiliation
Poznan University of Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Poznan University of Medical Sciences
City
Poznań
ZIP/Postal Code
60-781
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katarzyna Hojan, MD, PhD
Phone
+48618546573
Email
khojan@ump.edu.pl
First Name & Middle Initial & Last Name & Degree
Slawomir Tobis, PhD
Phone
+48618546573
Email
stobis@ump.edu.pl

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36012033
Citation
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.
Results Reference
derived

Learn more about this trial

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

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