NCT05130736UnknownNot Applicable
The Use of a Rehabilitation Robot in Patients With Post-COVID-19 Fatigue Syndrome
Poznan University of Medical Sciences2 sites in 1 country80 target enrollmentStarted: August 1, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- Change in muscle fatigue assessment
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •nutritional disorders
- •addiction to alcohol or psychoactive substances
- •severe obesity
- •overtraining
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- Change in cognitive ability 1(Baseline, after 3 and after 8 weeks)
- Change in cognitive ability 2(Baseline, after 3 and after 8 weeks)
- Change in functional physical ability 1(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 2(Baseline, after 3 and after 8 weeks)
- Change in functional physical ability 4(Baseline, after 3 and after 8 weeks)
- Change in the quality of life(Baseline, after 3 and after 8 weeks)
- Change in depressive symptoms(Baseline, after 3 and after 8 weeks)
Investigators
Study Sites (2)
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