- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06899451
Impact of Basophobia on Balance and Functional Outcomes in Patients With Stroke (stroke)
Impact of Basophobia on Balance and Functional Outcomes in Patients With Stroke.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Cairo, Egypt
- CairoU
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
an ischemic stroke and having had the disease for longer than three months have frequent falling, having sufficient cognition (as measured by a Montreal Cognitive Assessment score of over 26) and having upper and lower extremity spasticity ranging from (grade 1+: 2) on a modified Ashworth scale
Exclusion Criteria
) Musculoskeletal issues, such as severe arthritis, total hip arthroplasty, knee surgery, lower extremity fractures within the previous six months, or contractures brought on by a fixed deformity and/or disparity in leg length, 2) Instable medical conditions (e.g., unstable angina, recent myocardial infarction, history of congestive heart failure, major heart valve problems, or unstable hypertension);
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
basophobia in stroke patients
The study will be conducted on 80 stroke patients , will randomly assigned to one of two groups using a secure system of opaque closed envelopes as study group (GA) and control group (GB) : - - |
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Berg Balance Scale
Time Frame: 5 months
|
is a five-point scaling score, a range of Zero - 4. "Zero" was given at the least level of function, while grade "4" will be given at the highest level of function.
The scores are classified as follows: 41-56 = low fall risk, 21-40 = medium fall risk, and 0 -20 = high fall risk
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5 months
|
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The 16-item Fall Efficacy Scale-International
Time Frame: 5 months
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utilized to evaluate fear of falls.Varying from one (not concerned) to four (very concerned).
For data analysis, the overall score, which was the sum of the 16 answers and ranged from 16 to 64 points, was utilized.
A greater total score means the patients are more concerned about falling
|
5 months
|
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Timed Up and Go Test (TUG)
Time Frame: 5 months
|
starts with the patient getting up from the chair, walk 3 meters once a signal is given, walk 3 meters back to the chair, and then sit down calculating time taken by the patient
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5 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
fear of falling
Time Frame: 5 months
|
Biodex Balance Systems
|
5 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Heba Gaber, phd, ALRyada university for science and technology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PT.BU.EC.13
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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