Impact of Basophobia on Balance and Functional Outcomes in Patients With Stroke (stroke)

June 14, 2025 updated by: Heba Mohamed Gaber, Cairo University

Impact of Basophobia on Balance and Functional Outcomes in Patients With Stroke.

Several studies have reported that the physical functions associated with falls, including motor performance, postural balance, flexibility, and muscle strength, are also associated with FoF. Patients with stroke have trouble performing ADLs, including washing their face, eating, bathing, dressing, toileting, and walking, which also affect FoF. Anxiety and depression are common affective disorders in patients with stroke and significantly increase FoF .

Study Overview

Detailed Description

People who are afraid of falling because they can't keep their balance can utilize This makes them less susceptible to fall and high tendency to prevent it.

Study Type

Observational

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Cairo, Egypt
        • CairoU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with stroke

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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) : -

-

  1. Systematic desensitization: 2 techniques

    1. Jacobson's technique (progressive muscle relaxation):
    2. Guided imagery training is a relaxation technique
  2. Goal-directed paradigm (selected program)
Other Names:
  • goal directed paradigm and balance

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
5 months
The 16-item Fall Efficacy Scale-International
Time Frame: 5 months
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
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
5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fear of falling
Time Frame: 5 months
Biodex Balance Systems
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Heba Gaber, phd, ALRyada university for science and technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2024

Primary Completion (Actual)

March 3, 2025

Study Completion (Actual)

March 3, 2025

Study Registration Dates

First Submitted

March 21, 2025

First Submitted That Met QC Criteria

March 21, 2025

First Posted (Actual)

March 28, 2025

Study Record Updates

Last Update Posted (Actual)

June 18, 2025

Last Update Submitted That Met QC Criteria

June 14, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make IPD available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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