COVID-19 Respiratory InfectionNCT05813886
Evaluation of Dynamic Balance After Recovery From COVID 19 Disease
An observational study of COVID-19 Respiratory Infection, run by October 6 University at 1 site in Egypt.
Trial summary
effect of post covid-19 on dynamic balance in patients after recovery from covid-19 disease. Read more about this study
- Who is it for?
- Ages 30 to 40 years
- Conditions the study is for
- COVID-19 Respiratory Infection
- What is being tested?
- biodex balance system
- How many people
- 25 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Feb 2022to 21 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 40 years
- All sexes
- Adult
Study population: 25 patients (males and females) who recovered from Covid-19 disease will be selected from 6 october unversity Hospital outpatient Clinic their age from 30 -40 years old and 25 healthyage and gender matched (males and females
Who may be able to join
- 25post COVID-19 patients suffering from inbalance.
- Age will be ranged from 30 to 40 years old.
- Body mass index (BMI) will be ranged from 25 to 35 Kg/m2.
- Diagnosed as COVID-19 patients with a positive reverse transcription polymerase chain reaction (RT-PCR) result of SARS-CoV-2, or typical computerized tomography (CT) evidence of viral pneumonia.
- All enrolled patients with moderate covid-19 infection.
Who cannot join
- Severe disease or hospitalization at intensive care units will excluded from the study.
- Patients with previous hearing problems or balance disorders.
- Patients who had ear surgery, cardiovascular and circulatory problems,.
- Patients with orthopedic problems in the lower extremities due to other problems
- Patients with Any history of neurological or psychiatric disease, severe visual or auditory impairments.
- Diabetic patients.
Trial locations and contacts
1 site in 1 country.
About this study
effect of post covid-19 on dynamic balance in patients after recovery from covid-19 disease.
Read the detailed description
effect of post covid-19 on dynamic balance in patients after recovery from COVID disease.
patients will treated with medical protocol of COVID 19 an out-patient clinic , and followed up by the chest specialist . The balance tests of the patients were performed 2 to 14 weeks after their recovery from the disease, which was confirmed by the evaluations of the COVID staff and negative polymerase chain reaction test.the patients will evaluated using questionnaires. First, the question will whether feeling in balance in the daily life or not. The answer will classified as "yes"or "no". Second, asked to fill "Dizziness Handicap Inventory"(DHI), which is a multidimensional self- assessment scale created to evaluate the effects of dizziness and balance problems on the quality of life as well as the level of disability of the patients. Assess balance , which consists of a movable balance platform that provides up to 20 of surface tilt in a 360 range of motion. The platform is interfaced with computer software that enables the device to serve as an objective assessment of balance . The measure of postural stability includes the overall (OA), the anteroposterior (AP) and the mediolateral (ML) stability scores. A high score in the OA index indicates poor balance. The OA stability score is believed to be the best indicator of the overall ability of the patient to balance the platform
- Conditions
- COVID-19 Respiratory Infection
- Being tested
- biodex balance system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biodex balance systemOther
The balance tests of the patients were performed 2 to24 WEEKS after their recovery from the disease, which was confirmed by the evaluations of the Covid-19 staff and negative polymerase chain reaction test.
What is being measured
The primary outcome is the main question the study is designed to answer.
overall (OA), the anteroposterior (AP) and the Medio lateral (ML) stability scores
A high score in the OA index indicates poor balance. The OA stability score is believed to be the best indicator of the overall ability of the patient to balance the platform
Measured: 2 to24 WEEKS after their recovery from the disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start20 Feb 2022
- Primary completion30 Dec 2022
- Study completion21 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 Respiratory InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Mohamed Afify, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05813886
- Sponsor's protocol ID
- P.T.REC/012/003590
- Status last verified
- Apr 2023
- First submitted
- 11 Apr 2023
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Dynamic Balance After Recovery From COVID 19 Disease
- ClinicalTrials.gov ID
- NCT05813886
- Acronym / sponsor ID
- P.T.REC/012/003590
- Conditions
- COVID-19 Respiratory Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 20 Feb 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 21 Mar 2023 (actual)
- First posted
- 14 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
effect of post covid-19 on dynamic balance in patients after recovery from covid-19 disease.
Detailed description
effect of post covid-19 on dynamic balance in patients after recovery from COVID disease.
patients will treated with medical protocol of COVID 19 an out-patient clinic , and followed up by the chest specialist . The balance tests of the patients were performed 2 to 14 weeks after their recovery from the disease, which was confirmed by the evaluations of the COVID staff and negative polymerase chain reaction test.the patients will evaluated using questionnaires. First, the question will whether feeling in balance in the daily life or not. The answer will classified as "yes"or "no". Second, asked to fill "Dizziness Handicap Inventory"(DHI), which is a multidimensional self- assessment scale created to evaluate the effects of dizziness and balance problems on the quality of life as well as the level of disability of the patients. Assess balance , which consists of a movable balance platform that provides up to 20 of surface tilt in a 360 range of motion. The platform is interfaced with computer software that enables the device to serve as an objective assessment of balance . The measure of postural stability includes the overall (OA), the anteroposterior (AP) and the mediolateral (ML) stability scores. A high score in the OA index indicates poor balance. The OA stability score is believed to be the best indicator of the overall ability of the patient to balance the platform
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 30 to 40 years
- Sex
- All
- Age groups
- Adult
- Study population
- 25 patients (males and females) who recovered from Covid-19 disease will be selected from 6 october unversity Hospital outpatient Clinic their age from 30 -40 years old and 25 healthyage and gender matched (males and females
Key inclusion criteria (5 listed)
- 25post COVID-19 patients suffering from inbalance.
- Age will be ranged from 30 to 40 years old.
- Body mass index (BMI) will be ranged from 25 to 35 Kg/m2.
- Diagnosed as COVID-19 patients with a positive reverse transcription polymerase chain reaction (RT-PCR) result of SARS-CoV-2, or typical computerized tomography (CT) evidence of viral pneumonia.
- All enrolled patients with moderate covid-19 infection.
Key exclusion criteria (6 listed)
- Severe disease or hospitalization at intensive care units will excluded from the study.
- Patients with previous hearing problems or balance disorders.
- Patients who had ear surgery, cardiovascular and circulatory problems,.
- Patients with orthopedic problems in the lower extremities due to other problems
- Patients with Any history of neurological or psychiatric disease, severe visual or auditory impairments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biodex balance systemThe balance tests of the patients were performed 2 to24 WEEKS after their recovery from the disease, which was confirmed by the evaluations of the Covid-19 staff and negative polymerase chain reaction test. | Other | – |
Primary outcome
overall (OA), the anteroposterior (AP) and the Medio lateral (ML) stability scores
Time frame: 2 to24 WEEKS after their recovery from the disease
A high score in the OA index indicates poor balance. The OA stability score is believed to be the best indicator of the overall ability of the patient to balance the platform
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Respiratory Infection, run by October 6 University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall (OA), the anteroposterior (AP) and the Medio lateral (ML) stability scores (time frame: 2 to24 WEEKS after their recovery from the disease). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2023.