NCT05130736

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 3, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 23, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

November 23, 2021

Status Verified

November 1, 2021

Enrollment Period

12 months

First QC Date

September 3, 2021

Last Update Submit

November 19, 2021

Conditions

Post-Viral Fatigue Syndrome

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (8)

  • Change in functional physical ability 1

    Baseline, after 3 and after 8 weeks

  • Change in functional physical ability 2

    Baseline, after 3 and after 8 weeks

  • Change in functional physical ability 3

    Baseline, after 3 and after 8 weeks

  • Change in functional physical ability 4

    Baseline, after 3 and after 8 weeks

  • Change in cognitive ability 1

    Baseline, after 3 and after 8 weeks

  • +3 more secondary outcomes

Study Arms (2)

Robot

EXPERIMENTAL

Patients treated using a rehabilitation robot

Device: Robot rehabilitation

Control

ACTIVE COMPARATOR

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

Device: Robot rehabilitation

Interventions

Robot rehabilitationDEVICE

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

ControlRobot

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \- patients discharged from Intensive Care Units after undergone ventilator therapy due to COVID-19

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Poznan University of Medical Sciences

Poznan, 60-781, Poland

RECRUITING

Related Publications (1)

  • 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.

    PMID: 36012033DERIVED

MeSH Terms

Conditions

Fatigue Syndrome, Chronic

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesEncephalomyelitisNeuroinflammatory DiseasesNervous System DiseasesNeuromuscular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Katarzyna Hojan, MD, PhD

    Poznan University of Medical Sciences

    STUDY CHAIR

Central Study Contacts

Katarzyna Hojan, MD, PhD

CONTACT

+48618546573khojan@ump.edu.pl

Slawomir Tobis, PhD

CONTACT

+48618546573stobis@ump.edu.pl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2021

First Posted

November 23, 2021

Study Start

August 1, 2021

Primary Completion

July 31, 2022

Study Completion

December 31, 2022

Last Updated

November 23, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)