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

Sponsor
Karabuk University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06043960
Collaborator
Adnan Demirel (Other), Ahmet Burak Mavuş (Other)
60
13

Study Details

Study Description

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Other
Time Perspective:
Other
Official Title:
The Relationship Between Lower Limb Functionality, Foot Joint Position Sensation and Balance in Haemiplegic Patients
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Nov 1, 2024

Outcome Measures

Primary Outcome Measures

  1. Tecno Body Prokin Isokinetic Balance System [First Day]

    It expresses the equilibrium rate and the probability of falling.

  2. CSMI (CYBEX) Humac Norm Isokinetic Test and Exercise System [First day]

    Measures ankle joint position sensation.

  3. Berg Balance Scale [First day]

    It was developed for the evaluation of postural dominance.

  4. Fugl-Meyer Assessment of the lower extremity [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Karabuk University
  • Adnan Demirel
  • Ahmet Burak Mavuş

Investigators

  • Study Director: Adnan Demirel, Izzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fatma Hale Altınkaya, INVESTIGATOR, Karabuk University
ClinicalTrials.gov Identifier:
NCT06043960
Other Study ID Numbers:
  • BAIBÜFTR
First Posted:
Sep 21, 2023
Last Update Posted:
Sep 21, 2023
Last Verified:
Sep 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Fatma Hale Altınkaya, INVESTIGATOR, Karabuk University

Study Results

No Results Posted as of Sep 21, 2023