Open Poland:2022 Rehabilitation Robot in Patients With Post-Coronavirus Disease (COVID-19) Fatigue Syndrome

https://www.clinicaltrials.gov/ct2/show/NCT05130736?term=balance&recrs=ab&cond=me/cfs&draw=2&rank=2
Recruiting
Sponsor: Poznan University of Medical Sciences
Collaborators: EGZOTech sp. z o.o.; Szpital Wojewódzki w Poznaniu

Condition: Post-viral 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.

80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Experimental arm: Patients treated using a rehabilitation robot
Active control: Patients receiving traditional rehabilitation treatment (robot used only as assessment tool)


Primary Outcomes

1. 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)
   
   
2. 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

1. Change in functional physical ability 1 [ Time Frame: Baseline, after 3 and after 8 weeks ]
   Functional Independence Measure
   
   
2. Change in functional physical ability 2 [ Time Frame: Baseline, after 3 and after 8 weeks ]
   Barthel Index
   
   
3. Change in functional physical ability 3 [ Time Frame: Baseline, after 3 and after 8 weeks ]
   Berg Balance Test
   
   
4. Change in functional physical ability 4 [ Time Frame: Baseline, after 3 and after 8 weeks ]
   Short Physical Performance Battery
   
   
5. Change in cognitive ability 1 [ Time Frame: Baseline, after 3 and after 8 weeks ]
   Addenbrooke's Cognitive Examination (ACE-III)
   
   
6. Change in cognitive ability 2 [ Time Frame: Baseline, after 3 and after 8 weeks ]
   Montreal Cognitive Assessment
   
   
7. Change in the quality of life [ Time Frame: Baseline, after 3 and after 8 weeks ]
   WHOQOL
   
   
8. Change in depressive symptoms [ Time Frame: Baseline, after 3 and after 8 weeks ]
   Beck's Depression Inventory

Inclusion Criteria:
- patients discharged from Intensive Care Units after undergone ventilator therapy due to COVID-19

 

I thought this was worth posting for a couple of reasons:

One is that a rehabilitation robot is being used. That puts a whole new spin on the idea of moving as many patients away from expensive doctors and towards less expensive rehabilitation staff. I wonder exactly what the robot can do.

The other is that the whole concept of post-viral fatigue syndrome (and 'chronic fatigue syndrome' is also given as a key word for the study) as applied to this study looks terribly muddled. It looks as though they are only accepting patients discharged from the ICU. And the primary outcomes are strength tests over a fairly short time - so it might capture short term fatiguability, but it's really not addressing the core symptoms of post-viral fatigue syndrome/CFS. If there is training, then it's extremely likely that the patients' muscles will get a bit stronger, but that won't have changed the illness. There's a big risk that the study finds the robots help with the primary outcomes, and that is then taken to mean that rehabilitation by robot fixes post-viral fatigue syndrome/CFS/ long Covid.

 

It looks more like short term rehab for those who have been on ventilators to strengthen specific muscles.