Post-Viral Fatigue SyndromeNCT05130736
Rehabilitation Robot in Patients With Post-Coronavirus Disease (COVID-19) Fatigue Syndrome
A study testing Robot rehabilitation in people with Post-Viral Fatigue Syndrome, run by Poznan University of Medical Sciences at 1 site in Poland.
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Post-Viral Fatigue Syndrome
- What is being tested?
- Robot rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePoland
- Study dates
- 1 Aug 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients discharged from Intensive Care Units after undergone ventilator therapy due to COVID-19
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Poznan University of Medical Sciences
Poznan, 60-781
Katarzyna Hojan, MD, PhD, +48618546573, khojan@ump.edu.pl
Slawomir Tobis, PhD, +48618546573, stobis@ump.edu.pl
About this study
Official title: 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.
- Conditions
- Post-Viral Fatigue Syndrome
- Being tested
- Robot rehabilitation
- Medical subject headings
- Fatigue Syndrome, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot rehabilitationDevice
Effectiveness of using a rehabilitation robot in post-COVID-19 rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Robot | Experimental | Patients treated using a rehabilitation robot Receives: Device: Robot rehabilitation |
| Control | Active comparator | Patients receiving traditional rehabilitation treatment (robot used only as assessment tool) Receives: Device: Robot rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in muscle fatigue assessment
Raw robot measurement data (isometric contraction of the muscle for 60 s - biceps, quadriceps)
Measured: Baseline, after 3 and after 8 weeks
Change in isokinetic muscle force
Raw robot measurement data (5 repetitions during measurement with LUNA)
Measured: Baseline, after 3 and after 8 weeks
Secondary outcomes (8)
Change in functional physical ability 1
Functional Independence Measure
Measured: Baseline, after 3 and after 8 weeks
Change in functional physical ability 2
Barthel Index
Measured: Baseline, after 3 and after 8 weeks
Change in functional physical ability 3
Berg Balance Test
Measured: Baseline, after 3 and after 8 weeks
Change in functional physical ability 4
Short Physical Performance Battery
Measured: Baseline, after 3 and after 8 weeks
Change in cognitive ability 1
Addenbrooke's Cognitive Examination (ACE-III)
Measured: Baseline, after 3 and after 8 weeks
Change in cognitive ability 2
Montreal Cognitive Assessment
Measured: Baseline, after 3 and after 8 weeks
Change in the quality of life
WHOQOL
Measured: Baseline, after 3 and after 8 weeks
Change in depressive symptoms
Beck's Depression Inventory
Measured: Baseline, after 3 and after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start1 Aug 2021
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-Viral Fatigue SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- EGZOTech sp. z o.o., Szpital Wojewódzki w Poznaniu
- Responsible party
- Sponsor
- Investigators
- Katarzyna Hojan, MD, PhD, Study chair, Poznan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05130736
- Sponsor's protocol ID
- 514/21
- Status last verified
- Nov 2021
- First submitted
- 3 Sep 2021
- Last updated
- 23 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 36012033
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of a Rehabilitation Robot in Patients With Post-COVID-19 Fatigue Syndrome
- ClinicalTrials.gov ID
- NCT05130736
- Acronym / sponsor ID
- 514/21
- Conditions
- Post-Viral Fatigue Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Collaborators
- EGZOTech sp. z o.o., Szpital Wojewódzki w Poznaniu
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 23 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot | Experimental | Device: Robot rehabilitationPatients treated using a rehabilitation robot |
| Control | Active comparator | Device: Robot rehabilitationPatients receiving traditional rehabilitation treatment (robot used only as assessment tool) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients discharged from Intensive Care Units after undergone ventilator therapy due to COVID-19
Key exclusion criteria (7 listed)
- active medical condition (infections; tumors; rheumatological, metabolic, endocrine, autoimmunological, cardiovascular diseases)
- bipolar disorder
- dementia
- nutritional disorders
- addiction to alcohol or psychoactive substances
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robot rehabilitationEffectiveness of using a rehabilitation robot in post-COVID-19 rehabilitation | Device | Control, Robot |
Primary outcome
Change in muscle fatigue assessment
Time frame: Baseline, after 3 and after 8 weeks
Raw robot measurement data (isometric contraction of the muscle for 60 s - biceps, quadriceps)
Change in isokinetic muscle force
Time frame: Baseline, after 3 and after 8 weeks
Raw robot measurement data (5 repetitions during measurement with LUNA)
8 secondary outcomes
Change in functional physical ability 1
Time frame: Baseline, after 3 and after 8 weeks
Change in functional physical ability 2
Time frame: Baseline, after 3 and after 8 weeks
Change in functional physical ability 3
Time frame: Baseline, after 3 and after 8 weeks
Change in functional physical ability 4
Time frame: Baseline, after 3 and after 8 weeks
Change in cognitive ability 1
Time frame: Baseline, after 3 and after 8 weeks
Change in cognitive ability 2
Time frame: Baseline, after 3 and after 8 weeks
Change in the quality of life
Time frame: Baseline, after 3 and after 8 weeks
Change in depressive symptoms
Time frame: Baseline, after 3 and after 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
- Derived from this study: PubMed 36012033Zasadzka 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katarzyna Hojan, MD, PhD study chair
Poznan University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot rehabilitation in people with Post-Viral Fatigue Syndrome, run by Poznan University of Medical Sciences at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katarzyna Hojan, MD, PhD (+48618546573, khojan@ump.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in muscle fatigue assessment (time frame: Baseline, after 3 and after 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05130736, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2021.