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NCT Number: NCT07174037

Impact of Planter Flexors Spasticity on Postrual Stabilty and Functional Outcome in Pateints With Stroke

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

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

45 year–60 year

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).
  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Low spasticity group

Other

low sapsticity (grade 1-2) unilateral ischemic stroke will be participate in this group

High spasticity group

Other

high sapsticity (grade 3-4) unilateral ischemic stroke will be participate in this group

Primary outcomes

  1. 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

    • 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

  2. 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.

  3. postural stability

    Time frame: up to thirty minutes

    biodex balance system will be used to assess postural stability

  4. risk of falling index

    Time frame: up to thirty minutes

    biodex balance system will be used to assess risk of falling

  5. 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

  6. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

radwa ameen, master

CONTACT

[email protected]

01140174591

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Acronym: PFS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 15, 2025
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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