Specialty: Critical care, Primary sub-specialty: Critical Care
Conditions
Interventions
VeloVR is a novel interactive technology-based device developed using commercial off the shelf (COTS) interface devices combined with custom designed gaming software. The MotoMed ergometer will be set
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient in ICU 2. Conscious and able to communicate 3. Aged over 18 years, any gender 4. RASS score -1 to +1 5. Diagnosed with ICU-AW as defined by the presence of 1, 2, 5, and either 3 or 4 from: 5.1. Weakness developing after the onset of critical illness 5.2. The weakness being generalized (involving both proximal and distal muscles), symmetrical, flaccid, and generally sparing the cranial nerves (e.g. facial grimace is intact) 5.3. Muscle power assessed by the Medical Research Council (MRC) sum score of 0.48 (or a mean score of 0.4 in all testable muscle groups) noted on 2 occasions separated by 24 hours 5.4. Dependence on mechanical ventilation 5.5. Causes of weakness other than ICUAW have been excluded
Exclusion criteria
Exclusion criteria: Patients: 1. Severe visual loss 2. Active delirium or psychosis at screening from the Richmond Agitation and Sedation Score (RASS) and the Confusion Assessment Method for the ICU (CAM-ICU) score 3. Severe cognitive impairment or encephalopathy 4. Orthopaedic patients with contraindications to mobilise (e.g. pelvic / spinal fractures) 5. Poor prior level of mobility (< 10yds) 6. Neuromuscular disease (e.g. Motor Neurone Disease) 7. Expected withdrawal of treatment/palliative care in process 8. Patients with already established rehabilitation pathways (e.g. amputees) 9. Previous participation in this study ?
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility and acceptability outcomes: 1. Ability to recruit participants to the REVERE Move study is assessed by dividing the total number of participants by total screened 2. Participant completion of the REVERE Move protocol is measured by recording the duration in minutes at the end of each session 3. Usability of the VeloVR system by patient users is assessed using a modified system usability scale at the end of each session 4. Usability of the VeloVR by staff users is assessed using a modified system usability scale at the end of each session 5. Safety and adverse events associated with use of the VeloVR system is assessed through patient responses end of each session 6. Patient ability and willingness to complete measurement tools, including semi-structured interview is assessed through patient responses end of each session | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Distance covered during each session (as measured by ergometer) in metres is measured using the MotoMed dashboard at the end of each session. 2. Duration of active cycling during each session is measured in minutes/seconds at the end of each session 3. Total duration of session is measured in minutes/seconds at the end of each session 4. Active:passive ratio during each session is measured using the MotoMed dashboard at the end of each session 5. Perceived dyspnoea during ergometry session is measured using the Borg Breathlessness scale (1-10) at the end of each session 6. Pain and anxiety experienced during ergometry session is measured using a visual analogue scale (VAS) at the end of each session 7. Perceived enjoyment during the MotoMed/VeloVR session is measured using the Likert scale at the end of each session 8. Perceived competitiveness of the VeloVR competition scenario is measured using the Likert scale at the end of each session 9. Mood after MotoMed/VeloVR session is measured using the Likert scale at the end of each session 10. Exercise self-efficacy after MotoMed/VeloVR session is measured using the Likert scale at the end of each session 11. Perceived exertion during ergometry session is measured using the Borg scale (1-10) at the end of each session 12. Side effects experienced during ergometry e.g. nausea is measured by the a semi-structured interview at the end of each session 13. Adverse events experienced during ergometry – e.g. dislodging of intravascular catheters is measured through clinical observation at the end of each session 14. Duration of mechanical ventilation is measured in days on discharge from ICU 15. Duration of tracheal intubation (until decannulation of trachea) is measured in days on discharge from ICU 16. Patient mobility is measured using the Manchester Mobility Score on ICU discharge 17. Severity of ICU-Acquired Weakness is measured using the MRC-Sum Score at ICU discharge 18. Functional performance is measured using the | — |
Countries
United Kingdom
Outcome results
None listed