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

NCT06043960 | Completed

• 1 other identifier: BAIBÜFTR
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Being Between 40-80 Years Old; Being Diagnosed With Haemiplegia; Getting 20 Points or More in the Mini Mental Test; Volunteering to Participate in the Study; Level 2 or Above According to Functional Ambulation Classification

Keywords

Stroke; Proprioception; Lower limb functionality; Ankle joint; Balance

Outcome Measures

Primary Outcomes (8)

• Tecno Body Prokin Isokinetic Balance System

  It expresses the equilibrium rate and the probability of falling.

  First Day

• CSMI (CYBEX) Humac Norm Isokinetic Test and Exercise System

  Measures ankle joint position sensation.

  First day

• Berg Balance Scale

  It was developed for the evaluation of postural dominance.

  First day

• Fugl-Meyer Assessment of the lower extremity

  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.

  First day

• Tinetti Fall Activity Scale

  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.

  First day

• Time Up Go Test

  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.

  First day

• Mini Mental Test

  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.

  First day

• Romberg Test

  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.

  First day

Interventions

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

Also known as: Tecno Body Prokin Isokinetic Balance System

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Individuals with haemiplegia after stroke

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karabuk University: lead
• Bolu Izzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital: collaborator

Study Sites (1)

Izzet Baysal Physical Therapy and Rehabilitation Education and Research Hospital

Bolu, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Adnan Demirel

  Izzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: INVESTIGATOR

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: September 21, 2023
• Study Start: November 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: February 1, 2024
• Last Updated: April 2, 2024

Record last verified: 2024-03

Locations

TU (1)