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

NCT ID: NCT05130736

Last Updated: 2021-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Post-Viral Fatigue Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Robot

Patients treated using a rehabilitation robot

Group Type EXPERIMENTAL

Robot rehabilitation

Intervention Type DEVICE

Effectiveness of using a rehabilitation robot in post-COVID-19 rehabilitation

Control

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

Group Type ACTIVE_COMPARATOR

Robot rehabilitation

Intervention Type DEVICE

Effectiveness of using a rehabilitation robot in post-COVID-19 rehabilitation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Robot rehabilitation

Effectiveness of using a rehabilitation robot in post-COVID-19 rehabilitation

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

EGZOTech sp. z o.o.

UNKNOWN

Sponsor Role collaborator

Szpital Wojewódzki w Poznaniu

UNKNOWN

Sponsor Role collaborator

Poznan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Katarzyna Hojan, MD, PhD

Role: STUDY_CHAIR

Poznan University of Medical Sciences

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Poznan University of Medical Sciences

Poznan, , Poland

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Poland

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Katarzyna Hojan, MD, PhD

Role: CONTACT

Phone: +48618546573

Email: [email protected]

Slawomir Tobis, PhD

Role: CONTACT

Phone: +48618546573

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Katarzyna Hojan, MD, PhD

Role: primary

Slawomir Tobis, PhD

Role: backup

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 36012033 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

514/21

Identifier Type: -

Identifier Source: org_study_id