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Completed

NCT Number: NCT06043960

The Relationship Between Lower Limb Functionality, Foot Joint Position Sensation and Balance in Haemiplegic Patients

Stroke is defined as a neurological disorder resulting from acute focal damage to the central nervous system caused by vascular factors, which may include cerebral infarction, intracerebral haemorrhage and subarachnoid haemorrhage. Postural balance is a critical factor affecting walking and gait performance in the community after stroke. Gait disorders contribute significantly to functional disability in individuals after stroke. These impairments encompass a variety of changes, including muscle weakness in the affected lower limb, resulting in reduced weight bearing on that limb. This results in a slower and less safe gait. Given the impact on gait, functional mobility is also compromised, including daily activities such as sitting, standing, walking, turning and climbing or descending stairs. Proprioception is impaired in a large percentage of individuals following stroke. The presence of proprioception deficits has been identified as an important determinant of unfavourable functional outcomes after stroke, especially in terms of achieving independence in basic activities of daily living and length of hospital stay. In the literature, there are no studies investigating the relationship between ankle position sense and lower extremity functionality with balance and falls using Humac Norm Isokinetic Machine and Tecno Body Prokin Isokinetic Balance System simultaneously.

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Key information

Conditions

Being Between 40-80 Years Old Being Diagnosed With Haemiplegia Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Getting 20 Points or More in the Mini Mental Test Level 2 or Above According to Functional Ambulation Classification Nervous System Diseases Stroke Vascular Diseases Volunteering to Participate in the Study

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Izzet Baysal Physical Therapy and Rehabilitation Education and Research Hospital

Bolu, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Individuals aged 40-80 years
  • Volunteering to participate in the study

Exclusion criteria

  • Being diagnosed with vertigo
  • Having a history of serious neurological diseases such as Parkinson's disease, multiple sclerosis except hemiplegia
  • Having a previous operation for the lower limb
  • Poor co-operation

Treatment and study plan

Humac Norm İsokinetic Machine

Other

Tecno Body Prokin Isokinetic Balance System CSMI (CYBEX) Humac Norm Isokinetic Testing and Exercise System Romberg Test Mini Mental Test (MMSE) Fugl-Meyer Assessment of the lower limb

Other names: Tecno Body Prokin Isokinetic Balance System

Primary outcomes

  1. Tecno Body Prokin Isokinetic Balance System

    Time frame: First Day

    It expresses the equilibrium rate and the probability of falling.

  2. CSMI (CYBEX) Humac Norm Isokinetic Test and Exercise System

    Time frame: First day

    Measures ankle joint position sensation.

  3. Berg Balance Scale

    Time frame: First day

    It was developed for the evaluation of postural dominance.

  4. Fugl-Meyer Assessment of the lower extremity

    Time frame: First day

    Is used for the assessment of motor function after stroke. The total possible score for the lower limb is 34. The higher the score, the better the performance.

  5. Tinetti Fall Activity Scale

    Time frame: First day

    It measures how confident the individual is in performing some activities of daily living such as reaching shelves, walking around the house, dressing and undressing, and personal care without falling. There is a rating between 1-10. Each question is defined as 1 (very confident), 10 (not confident at all). If the total score is >70, there is fear of falling.

  6. Time Up Go Test

    Time frame: First day

    The purpose of the test is to provide an approach to observing gait. The patient is observed and timed while getting up from the chair, walking 3 metres, turning, walking back and sitting again.

  7. Mini Mental Test

    Time frame: First day

    The MMSE (Mini-Mental State Examination) is a 30-question assessment tool commonly used by health professionals to assess cognitive functioning, including elements such as thinking, communication, comprehension and memory, to detect potential disorders.

  8. Romberg Test

    Time frame: First day

    The Romberg sign is a potential indicator of a neurological disorder linked to proprioception, impairing the visual and vestibular elements that are crucial for maintaining balance.

Sponsors and collaborators

Lead sponsor

Karabuk University

Other

Collaborators

  • Bolu Izzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 21, 2023
Registry last updated
Apr 2, 2024

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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