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

March 31, 2024 updated by: Fatma Hale Altınkaya, Karabuk University
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 Overview

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bolu, Turkey
        • Izzet Baysal Physical Therapy and Rehabilitation Education and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Individuals with haemiplegia after stroke

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tecno Body Prokin Isokinetic Balance System
Time Frame: First Day
It expresses the equilibrium rate and the probability of falling.
First Day
CSMI (CYBEX) Humac Norm Isokinetic Test and Exercise System
Time Frame: First day
Measures ankle joint position sensation.
First day
Berg Balance Scale
Time Frame: First day
It was developed for the evaluation of postural dominance.
First day
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.
First day
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.
First day
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.
First day
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.
First day
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.
First day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Actual)

January 1, 2024

Study Completion (Actual)

February 1, 2024

Study Registration Dates

First Submitted

September 5, 2023

First Submitted That Met QC Criteria

September 12, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

March 31, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • BAIBÜFTR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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