- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06043960
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
Status
Completed
Conditions
Intervention / Treatment
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
-
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Bolu, Turkey
- Izzet Baysal Physical Therapy and Rehabilitation Education and Research Hospital
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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.
Sponsor
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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