Describing Balance Function in Patients Post-COVID-19
Conditions: Covid19
Sponsor: Duke University

 
 
 
 
 
 
 
 
 
 
 
Describing Balance Function in Patients Post-COVID-19 
 
NCT04914364 
 
Document Date: July 30, 2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Purpose of the Study 
  
We hypothesize that patients with COVID-19 will have residual balance dysfunction that are 
more similar to those with neurological dysfunction than respiratory illness. 
 
Background & Significance 
 
People with cardiorespiratory dysfunction specifically chronic obstructive pulmonary disease 
(COPD) and lung transplantation have postural instability and increased risk of falls compared to age 
matched controls. People with COPD are 55% more likely to have falls than their non-COPD 
counterparts.  It is speculated that this increase in fall risk is due to muscle weakness, attention and 
ability to dual task, decline in activity, polyneuropathy, and pain. 
 
Ninety percent of patients with a history of COVID-19 report at least 1 neurological symptom. 
The neurological symptoms can occur before, during, or after the respiratory symptoms. Neurological 
symptoms include gustatory and olfactory dysfunction (35-88%), myalgia (19%), headache (15%), altered 
mental status, confusion or delirium (9%), and dizziness (9%).  In an early report from Italy, they describe 
myopathy and neuropathy in addition to impaired balance and gait.  Balance deficits could logically 
follow many of these neurological signs and symptoms.  Although there is anecdotal evidence for 
imbalance immediately and long after COVID-19, we are unable to find a study that looked at balance 
quantitatively.  Understanding balance dysfunction following COVID-19 can assist medical personnel in 
directing intervention for gait and balance dysfunction. 
 
The act of maintaining upright posture or balance depends on both sensory and motor 
responses.  Sensory information from vision, vestibular and somatosensory provide reference about 
where the body is in space and how it is moving so that appropriate motor responses can be generated.  
One can hypothesize that in patients with respiratory dysfunction, balance is affected through a lack of 
oxygen to the muscles making it a motor balance dysfunction. With neurologic dysfunction, difficulties 
can be seen with both the sensory and motor systems.  Our balance outcome measures can 
differentiate between motor and sensory balance dysfunction.  The TImed “Up & Go” is a measure of 
motor balance while the modified Clinical Test of Sensory Interaction measures the brain's use of visual, 
vestibular, and somatosensory for balance.  We will describe the differences in the results of the TUG 
and the mCTSIB in patients with COVID-19 with previously documented balance dysfunction in patients 
with respiratory and neurological dysfunction (from existing literature). 
 
Design & Procedures 
 
Subjects who meet inclusion criteria (see below) will complete informed consent by the PI or 
one of the sub-investigators. 
 
Subjects will complete the Activities-Specific Balance Confidence (ABC) Scale, provide number of 
falls in the past year and since hospital admission, and indicate their dizziness level on a 0-10 visual 
analog scale (VAS) for current, best and worst in the last 24 hours, and provide a description of dizziness 
(Asked “How would you describe your dizziness?”). 
 
HR, RR, BP, and SpO2 will be measured at rest and after all outcome measures are completed.  
RPE (0-10 per modified Borg scale) will be measured after each outcome measure.  In addition, HR will 
be measured after each outcome measure. SpO2 will be continually monitored via pulse oximetry.  

Fraction of inspired oxygen (FiO2) will be titrated per MD orders. If SpO2 drops below MD-specified 
parameters, patients will first be given a 3-minute seated rest break. If SpO2 recovers above MD-
specified parameters after rest break, activity will resume.  If SpO2 remains below MD-specified 
parameters after rest break or continues to drop with activity, FiO2 will be titrated to maintain SpO2 
within MD-specified parameters.   
 
The Timed “Up & Go” (TUG) and Modified Clinical Test of Sensory Interaction in Balance 
(mCTSIB) outcome measures will be randomized per Excel’s RAND function and performed in the order 
assigned.  
 
During the TUG, subjects will be timed while standing from a standard chair, walking 3 meters at 
self-selected speed, turning around, walking back, and sitting back down. Subjects will be guarded by a 
physical therapist while they are walking to prevent falls. 
 
During the mCTSIB, subjects will be timed (for a maximum of 30 seconds) standing on a firm 
surface, eyes open and eyes closed, then on a foam surface (Airex pad), eyes open and eyes closed.  
Subjects will have their arms folded across the chest and feet shoulder distance apart. If it is felt by the 
investigators that the subjects did not perform at their best level, they will be given a second trial.  
Subjects will be guarded by a physical therapist during balance activities to prevent falls.  
 
Performance on the outcome measures will be recorded on a data sheet and entered into the 
spreadsheet manually. 
 
Data will be recorded in a password-protected computerized database.  Comorbidities and 
medications will be included from the medical record.  Only Duke study personnel will access the 
medical record.  The database will be de-identified before sharing with the co-investigators who are not 
Duke employees by a Duke employee. 
 
This is a descriptive study and no intervention will be provided.  All the examination/outcome 
measures are standard measures used in physical therapy. 
 
Selection of Subjects 
  
Inclusion Criteria:  
 
• 
Age > 18 years and < 90 years 
• 
Primary or secondary diagnosis of COVID- 19 during hospitalization and off COVID-19 isolation 
• 
Receiving care in acute inpatient 
• 
Ability to ambulate 20’ with or without an assistive device without dropping >10% of resting 
SpO2 (determined from existing PT evaluation) 
• 
Ability to stand with no more than contact guard assistance (determined from existing PT 
evaluation) 
• 
Not requiring use of mechanical ventilation  
• 
Minimum resting SpO2 of 88% with or without supplemental oxygen 
• 
No neurological or orthopedic dysfunction that would affect balance 
• 
Cognitively intact and able to follow directions and provide consent  
 

Exclusion Criteria: 
 
• 
History of 2 or more falls in the year prior to COVID-19 diagnosis or history of balance 
dysfunction 
 
Subject Recruitment and Compensation 
 
Potential participants will be identified by Duke study personnel using Maestro Care filters (i.e. 
COVID-19 and active physical therapy consults).  Once identified, patients will be screened via chart 
review to ensure they meet inclusion and exclusion criteria for the study.  The treating physical therapist 
or assigned nurse will approach all patients who meet the inclusion and exclusion criteria to see if they 
are interested in participating.  Additional screening for current resting SpO2 parameters and number of 
falls will occur upon approach as this information cannot be obtained via chart review.  Consent will be 
obtained from either the PI or one of the sub-investigators.   No compensation will be provided. 
 
No sample size calculations were performed as this is a descriptive study.  We plan to approach 
up to 40 subjects with a goal sample size of around 30-35 to describe balance in COVID-19.  
 
Risk/Benefit Assessment 
 
The study has small risk and no direct patient benefit but has the potential to provide 
information for patients who may benefit from future interventions aimed at addressing balance deficits 
in patients with COVID-19. Physical activity is generally considered to be safe for patients with 
cardiorespiratory conditions, but patients may incur the following risks:  
 
• 
Risk of falls or musculoskeletal soreness or injury. This is not greater than what is experienced 
during standard physical therapy treatment. Subjects will be guarded to prevent falls. 
 
• 
Risk of increased respiratory symptoms but these will be monitored and examination will be 
discontinued if subjects’ SpO2 drops > 10% of resting SpO2.  Any increased symptoms should be 
transitory. 
 
Data Analysis & Statistical Considerations 
 
This is a descriptive study so scores on the balance tests will be described by means and 
standard deviations for each group.  Spearman correlation coefficients or linear regression will be used 
to determine if vital signs influence the balance scores. 
 
Data & Safety Monitoring 
 
The investigators will monitor for adverse events and report as required to the IRB.  As there is 
no increase in risk beyond what is experienced in standard physical therapy intervention, no data 
monitoring committee will be used. 
 
Duke study personnel who are interacting with patients will follow all Duke COVID-19 policies.  
Any required PPE will be worn during study visits.  Inclusion criteria requires that patients be off 
isolation prior to approach for the study.