Stroke, IschemicstrokeNCT06899451
Impact of Basophobia on Balance and Functional Outcomes in Patients With Stroke
An observational study of Stroke, Ischemic and Stroke Hemorrhagic, run by Cairo University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 60 years
- Conditions the study is for
- Stroke, Ischemic, Stroke Hemorrhagic, Balance
- What is being tested?
- systematic desensitization and balance
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Sep 2024to 3 Mar 2025
- How long will I take part?
- 12 Months
- 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 45 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with stroke
Who may be able to join
- 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
Who cannot join
- ) 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);
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 .
Read the 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.
- Conditions
- Stroke, Ischemic, Stroke Hemorrhagic, Balance
- Being tested
- systematic desensitization and balance
- Keywords
- fear of falling, balance, stroke
- Medical subject headings
- Ischemic Stroke, Hemorrhagic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
systematic desensitization and balanceOther
Also called goal directed paradigm and balance
- Systematic desensitization: 2 techniques
- Jacobson's technique (progressive muscle relaxation):
- Guided imagery training is a relaxation technique
- Goal-directed paradigm (selected program)
| Study group | Role | What they receive |
|---|---|---|
| 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) : -
- Receives: Other: systematic desensitization and balance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale
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
Measured: 5 months
The 16-item Fall Efficacy Scale-International
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
Measured: 5 months
Timed Up and Go Test (TUG)
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
Measured: 5 months
Secondary outcomes (1)
fear of falling
Biodex Balance Systems
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start9 Sep 2024
- Primary completion3 Mar 2025
- Study completion3 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 80 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- AlRyada University for Science & Technology
- Responsible party
- Principal investigator, Heba Mohamed Gaber, Cairo University
- Investigators
- Heba Gaber, phd, Study chair, ALRyada university for science and technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06899451
- Sponsor's protocol ID
- PT.BU.EC.13
- Acronym
- stroke
- Status last verified
- Jun 2025
- First submitted
- 21 Mar 2025
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Basophobia on Balance and Functional Outcomes in Patients With Stroke.
- ClinicalTrials.gov ID
- NCT06899451
- Acronym / sponsor ID
- stroke / PT.BU.EC.13
- Conditions
- Stroke, Ischemic, Stroke Hemorrhagic, Balance
- Keywords
- fear of falling, balance, stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- AlRyada University for Science & Technology
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- 3 Mar 2025 (actual)
- Study completion
- 3 Mar 2025 (actual)
- First posted
- 28 Mar 2025 (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.
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 .
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 design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| basophobia in stroke patients | – | Other: systematic desensitization and balanceThe 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) : - - |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with stroke
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- ) 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);
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 |
|---|---|---|
| systematic desensitization and balanceAlso: goal directed paradigm and balance1. 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 | basophobia in stroke patients |
Primary outcome
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
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
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
1 secondary outcome
fear of falling
Time frame: 5 months
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 18 Jun 2025.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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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.
Heba Gaber, phd study chair
ALRyada university for science and technology
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 Stroke, Ischemic and Stroke Hemorrhagic, run by Cairo 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 1 inclusion and 1 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 18 Jun 2025. 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?
Berg Balance Scale (time frame: 5 months). The study lists 3 primary outcomes in all. 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 18 Jun 2025.