StrokePFSNCT07174037
Impact of Planter Flexors Spasticity on Postrual Stabilty and Functional Outcome in Pateints With Stroke
An observational study of Stroke, run by Cairo University.
Trial summary
this study will be conducted to investigate the effect of planter flexors spasticity on postural stability, risk of falling and function outcomes in patients with stroke Read more about this study
- Who is it for?
- Ages 45 to 60 years
- Conditions the study is for
- Stroke
- What is being tested?
- Low spasticity group and High spasticity group
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2025to 30 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Sixty eight unilateral ischemic stroke patients as diagnosed by CT ''computed topography'' or MRI ''magnetic resonance imaging from both sexes and will be assigned to two groups depending on level of spasticity. * Low spasticity (grade 1 and 1+). * High spasticity (grade 2 and 3).
Who may be able to join
- Sixty eight first-ever unilateral ischemic stroke patients as diagnosed by CT ''computed topography'' or MRI ''magnetic resonance imaging.
- Patients will be both sexes.
- Their age ranges from 45 to 60 years
- The patients will be divided into 2 groups based on their level of ankle plantar flexor spasticity according to the Modified Ashworth Scale (MAS):
- Low spasticity (grade 1 and 1+).
- High spasticity (grade 2 and 3).
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- Duration of illness will be over 6 months post-stroke.
- Body mass index of patients will be ≤ 30 kg / m2
- Patients can stand independently.
- Normal cognitive abilities according to MOKA scale will be ≥ 24
Who cannot join
- Bilateral hemiplegia.
- Patients having any other neurological disorders affecting their lower limb extremity as MS, Parkinson disease, peripheral neuropathy.
- Patients with visual auditory impairment affecting their ability to complete task. 4.Patients with previous fracture of the lower limbs or any other musculoskeletal disorders such as severe arthritis, fixed ankle contracture, ankle surgery, leg length discrepancy or being treated with botulinum toxin injections within the past 3 months of study participation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
this study will be conducted to investigate the effect of planter flexors spasticity on postural stability, risk of falling and function outcomes in patients with stroke
Read the detailed description
Lower limb spasticity is a common following a cerebrovascular attack (CVA) or stroke, which can affect the balance and gait of patients. This then not only affects independence, and quality of life but increases the risk for other concerns, such as falling and an increased sedentariness, which could further affect health outcomes.The spasticity of the planter flexors disturbs walking, can impede toe clearance during the swing phase of gait causing the patient to fall as a result their toe 'catching' on the ground .In stroke patients characteristically the extensors of the leg are spastic and the flexors are weak . All these changes lead to gait disturbance as well as impaired functional mobility of patients.Studies have shown that patients with stroke have a higher risk of developing the fear of falling, which may be related to an increased risk of falling after stroke .The incidence of fear of falling after stroke has been reported to be approximately 32 to 66 percent. Fear of falling is associated with adverse consequences such as limited activity, increased incidence of falls, decreased quality of life, and increased hospitalization and case fatality rates
- Conditions
- Stroke
- Being tested
- Low spasticity group, High spasticity group
- Keywords
- Planter Flexors Spasticity, Postrual Stabilty, stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low spasticity groupOther
low sapsticity (grade 1-2) unilateral ischemic stroke will be participate in this group
High spasticity groupOther
high sapsticity (grade 3-4) unilateral ischemic stroke will be participate in this group
| Study group | Role | What they receive |
|---|---|---|
| Low spasticity group | thirty four patients with low spasticity grade (grade I and 2) will participate in this group Receives: Other: Low spasticity group | |
| High spasticity group | thirty four patients with high spasticity grade (grade 3 and 4) will participate in this group Receives: Other: High spasticity group |
What is being measured
The primary outcome is the main question the study is designed to answer.
spasticity
Modified Ashworth scale will be used to assess spasticity.The rater will score muscle spasticity from 0 to 4. Only one passive stretch will be applied to rate spasticity
The scale is as follows:
0: No increase in muscle tone
- Slight increase in muscle tone, with a catch and release or minimal resistance at the end of the range of motion when an affected part(s) is moved in flexion or extension 1+: Slight increase in muscle tone, manifested as a catch, followed by minimal resistance through the remainder (less than half) of the range of motion
- A marked increase in muscle tone throughout most of the range of motion, but affected part(s) are still easily moved
- Considerable increase in muscle tone, passive movement difficult
- Affected part(s) rigid in flexion or extension
Measured: up to thirty minutes
muscle spasticity
MyotonPRO will be used to assess spasticity. it can assess regional differences in tendon stiffness, such as variations along the Achilles tendon, and monitor stiffness modulation with joint position changes.
It is placed on the skin over the muscle. A brief, gentle tap from the probe causes the muscle to oscillate. The oscillations are analysed automatically by the device to calculate the muscle's mechanical characteristics, such as its tone, stiffness and how elastic it is.
Measured: up to thirty minutes
postural stability
biodex balance system will be used to assess postural stability
Measured: up to thirty minutes
risk of falling index
biodex balance system will be used to assess risk of falling
Measured: up to thirty minutes
risk of falling
The Morse Fall Scale (MFS) is one of the well- known tools both domestically and internationally for measuring fall risk in adults. It has the advantage of being easy to measure. The MFS has been validated in several studies and is considered a reliable tool for measuring fall risk. The MFS is composed of six variables that assess different risk factors for falling. Each variable is scored, and the total score determines the patient's fall risk.Each of the six variables is assigned a score, and the total score ranges from 0 to 125. The risk levels are categorized as follows:
Low Risk: 0-24 Moderate Risk: 25-44 High Risk: 45 and above
Measured: up to thirty minutes
functional mobility
The Timed Up and Go (TUG) test is a widely utilized clinical tool to assess functional Mobility.It involves timing an individual as they stand up from a chair with armrests, walk a distance of three meters at a comfortable place (with or without their usual walking aid), turn around, walk back, and sit down again
- 10 seconds: Normal mobility.
- 20 seconds: Good mobility, able to go out alone without gait aid.
- 30 seconds: Mobility problems, requires gait aid, cannot go outside alone.
- 14 seconds indicates a high risk of falls.
Measured: up to thirty minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start20 Sep 2025 (estimated)
- Primary completion30 Mar 2026 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radwa Shokry Abd Elmotaleb Ameen, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07174037
- Sponsor's protocol ID
- P.T.REC/012/005968
- Acronym
- PFS
- Status last verified
- Sep 2025
- First submitted
- 8 Sep 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Planter Flexors Spasticity on Postrual Stabilty and Functional Outcome in Pateints With Stroke
- ClinicalTrials.gov ID
- NCT07174037
- Acronym / sponsor ID
- PFS / P.T.REC/012/005968
- Conditions
- Stroke
- Keywords
- Planter Flexors Spasticity, Postrual Stabilty, stroke
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Sep 2025 (estimated)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 15 Sep 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.
this study will be conducted to investigate the effect of planter flexors spasticity on postural stability, risk of falling and function outcomes in patients with stroke
Detailed description
Lower limb spasticity is a common following a cerebrovascular attack (CVA) or stroke, which can affect the balance and gait of patients. This then not only affects independence, and quality of life but increases the risk for other concerns, such as falling and an increased sedentariness, which could further affect health outcomes.The spasticity of the planter flexors disturbs walking, can impede toe clearance during the swing phase of gait causing the patient to fall as a result their toe 'catching' on the ground .In stroke patients characteristically the extensors of the leg are spastic and the flexors are weak . All these changes lead to gait disturbance as well as impaired functional mobility of patients.Studies have shown that patients with stroke have a higher risk of developing the fear of falling, which may be related to an increased risk of falling after stroke .The incidence of fear of falling after stroke has been reported to be approximately 32 to 66 percent. Fear of falling is associated with adverse consequences such as limited activity, increased incidence of falls, decreased quality of life, and increased hospitalization and case fatality rates
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low spasticity group | – | Other: Low spasticity groupthirty four patients with low spasticity grade (grade I and 2) will participate in this group |
| High spasticity group | – | Other: High spasticity groupthirty four patients with high spasticity grade (grade 3 and 4) will participate in this group |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Sixty eight unilateral ischemic stroke patients as diagnosed by CT ''computed topography'' or MRI ''magnetic resonance imaging from both sexes and will be assigned to two groups depending on level of spasticity. * Low spasticity (grade 1 and 1+). * High spasticity (grade 2 and 3).
Key inclusion criteria (10 listed)
- Sixty eight first-ever unilateral ischemic stroke patients as diagnosed by CT ''computed topography'' or MRI ''magnetic resonance imaging.
- Patients will be both sexes.
- Their age ranges from 45 to 60 years
- The patients will be divided into 2 groups based on their level of ankle plantar flexor spasticity according to the Modified Ashworth Scale (MAS):
- Low spasticity (grade 1 and 1+).
Key exclusion criteria (3 listed)
- Bilateral hemiplegia.
- Patients having any other neurological disorders affecting their lower limb extremity as MS, Parkinson disease, peripheral neuropathy.
- Patients with visual auditory impairment affecting their ability to complete task. 4.Patients with previous fracture of the lower limbs or any other musculoskeletal disorders such as severe arthritis, fixed ankle contracture, ankle surgery, leg length discrepancy or being treated with botulinum toxin injections within the past 3 months of study participation.
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 |
|---|---|---|
| Low spasticity grouplow sapsticity (grade 1-2) unilateral ischemic stroke will be participate in this group | Other | Low spasticity group |
| High spasticity grouphigh sapsticity (grade 3-4) unilateral ischemic stroke will be participate in this group | Other | High spasticity group |
Primary outcome
spasticity
Time frame: up to thirty minutes
Modified Ashworth scale will be used to assess spasticity.The rater will score muscle spasticity from 0 to 4. Only one passive stretch will be applied to rate spasticity The scale is as follows: 0: No increase in muscle tone 1. Slight increase in muscle tone, with a catch and release or minimal resistance at the end of the range of motion when an affected part(s) is moved in flexion or extension 1+: Slight increase in muscle tone, manifested as a catch, followed by minimal resistance through the remainder (less than half) of the range of motion 2. A marked increase in muscle tone throughout most of the range of motion, but affected part(s) are still easily moved 3. Considerable increase in muscle tone, passive movement difficult 4. Affected part(s) rigid in flexion or extension
muscle spasticity
Time frame: up to thirty minutes
MyotonPRO will be used to assess spasticity. it can assess regional differences in tendon stiffness, such as variations along the Achilles tendon, and monitor stiffness modulation with joint position changes. It is placed on the skin over the muscle. A brief, gentle tap from the probe causes the muscle to oscillate. The oscillations are analysed automatically by the device to calculate the muscle's mechanical characteristics, such as its tone, stiffness and how elastic it is.
postural stability
Time frame: up to thirty minutes
biodex balance system will be used to assess postural stability
risk of falling index
Time frame: up to thirty minutes
biodex balance system will be used to assess risk of falling
risk of falling
Time frame: up to thirty minutes
The Morse Fall Scale (MFS) is one of the well- known tools both domestically and internationally for measuring fall risk in adults. It has the advantage of being easy to measure. The MFS has been validated in several studies and is considered a reliable tool for measuring fall risk. The MFS is composed of six variables that assess different risk factors for falling. Each variable is scored, and the total score determines the patient's fall risk.Each of the six variables is assigned a score, and the total score ranges from 0 to 125. The risk levels are categorized as follows: Low Risk: 0-24 Moderate Risk: 25-44 High Risk: 45 and above
functional mobility
Time frame: up to thirty minutes
The Timed Up and Go (TUG) test is a widely utilized clinical tool to assess functional Mobility.It involves timing an individual as they stand up from a chair with armrests, walk a distance of three meters at a comfortable place (with or without their usual walking aid), turn around, walk back, and sit down again * 10 seconds: Normal mobility. * 20 seconds: Good mobility, able to go out alone without gait aid. * 30 seconds: Mobility problems, requires gait aid, cannot go outside alone. * 14 seconds indicates a high risk of falls.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Cairo University.
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 10 inclusion and 3 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: opening soon, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact radwa ameen, master (01140174591, radwashokry@pt.svu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
spasticity (time frame: up to thirty minutes). The study lists 6 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 15 Sep 2025.