Evaluation of Dynamic Balance After Recovery From COVID 1... | NCT05813886

Studies
Evaluation of Dynamic Balance After Recovery From COVID 19 Disease

NCT05813886

Sponsor

October 6 University

Status

Completed

Last Update Posted

Apr 19, 2023Actual

Enrollment

25Actual

Phase

Not provided

Conditions

COVID-19 Respiratory Infection

Interventions

biodex balance system

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 20, 2022Actual

Primary Completion Date

Dec 30, 2022Actual

Completion Date

Mar 21, 2023Actual

First Submitted Date

Apr 11, 2023

First Submission Date that Met QC Criteria

Apr 11, 2023

First Posted Date

Apr 14, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 15, 2023

Last Update Posted Date

Apr 19, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
biodex balance system	Other	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	2 to24 WEEKS after their recovery from the disease

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

MALE AND FEMALE

Minimum Age

30 Years

Maximum Age

40 Years

Standard Ages

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

Sampling Method

Probability Sample