NCT04914364

Balance Function in Patients Post Corona Virus Disease 2019 (COVID-19)

Completed Results posted Last updated 19 September 2024

What this trial tests

trial testing Balance assessments in Covid19 in 28 participants. Completed in 22 June 2022.

Timeline

23 July 2021

Primary endpoint
22 June 2022

22 June 2022

Quick facts

Lead sponsor	Duke University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	28
Start date	23 July 2021
Primary completion	22 June 2022
Estimated completion	22 June 2022
Sites	1 location across United States

Drugs / interventions tested

• Balance assessments

Conditions studied

• Covid19 — all drugs for Covid19 →

Sponsor

Duke University

Who can join

18 and older, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Motor Balance as Measured by Timed Up and Go (TUG) Primary · Baseline

The TUG measures mobility, motor balance, walking ability, and falls risk based on how long it takes the patient to stand up, walk 10 feet, turn around, walk back, and sit down. \< 10 seconds = normal, \< 20 seconds = good mobility; can walk outside alone; does not require a walking aid, \< 30 seconds = walking and balance problems; cannot walk outside alone; requires walking aid.

Group	Value	95% CI
Patients Who Have Tested Positive for COVID-19	20.57	± 10.34

Sensory Influence on Balance as Measured by Modified Clinical Test of Sensory Interaction in Balance (mCTSIB) Secondary · Baseline

The mCTSIB assesses how well a patient is using sensory inputs when one or more sensory systems are compromised based on how long it takes the patient to complete the task under four different conditions. 1) Eyes Open, Firm Surface; 2) Eyes Closed, Firm Surface; 3) Eyes Open, Foam Surface; 4) Eyes Closed, Foam Surface. The trial is over when (a) the participant opens his/her eyes in an eyes closed condition, (b) raises arms from sides, (c) loses balance and requires manual assistance to prevent a fall.

mCTSIB eyes open firm surface

Group	Value	95% CI
Patients Who Have Tested Positive for COVID-19	30.0	± 0.00

mCTSIB eyes closed firm surface

Group	Value	95% CI
Patients Who Have Tested Positive for COVID-19	28.28	± 6.24

mCTSIB eyes open foam surface

Group	Value	95% CI
Patients Who Have Tested Positive for COVID-19	27.50	± 8.08

mCTSIB eyes closed foam surface

Group	Value	95% CI
Patients Who Have Tested Positive for COVID-19	19.41	± 1.89

Balance Confidence as Measured by Activities Specific Balance Confidence (ABC) Scale Secondary · Baseline

Self-report questionnaire where patients rate their balance confidence for performing activities. Scores range 0-100 where 0 indicates no balance confidence and 100 indicates complete balance confidence.

Group	Value	95% CI
Patients Who Have Tested Positive for COVID-19	66.88	± 17.61

Sponsor's own description

The purpose of this study is to describe balance deficits in patients post COVID-19. The information the investigators learn may help influence balance training exercises for patients post-COVID-19. Participants will have a primary or secondary diagnosis of COVID-19 during hospitalization and off COVID-19 isolation and be receiving care in an acute inpatient hospital. Following consent, participants will complete balance assessments and questionnaires about balance and dizziness in a single session. Vital signs will be monitored during the session.The greatest risks of this study include shortness of breath, and a risk of falling or musculoskeletal soreness.These risks are no greater than those experienced during a usual physical therapy visit.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.