Being Between 40-80 Years OldNCT06043960
The Relationship Between Lower Limb Functionality, Foot Joint Position Sensation and Balance in Haemiplegic Patients
An observational study of Being Between 40-80 Years Old and Being Diagnosed With Haemiplegia, run by Karabuk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Being Between 40-80 Years Old, Being Diagnosed With Haemiplegia, Getting 20 Points or More in the Mini Mental Test
- What is being tested?
- Humac Norm İsokinetic Machine
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2023to 1 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals with haemiplegia after stroke
Who may be able to join
- Individuals aged 40-80 years
- Volunteering to participate in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izzet Baysal Physical Therapy and Rehabilitation Education and Research Hospital
Bolu
About this study
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
- Being tested
- Humac Norm İsokinetic Machine
- Keywords
- Stroke, Proprioception, Lower limb functionality, Ankle joint, Balance
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Humac Norm İsokinetic MachineOther
Also called Tecno Body Prokin Isokinetic Balance System
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Tecno Body Prokin Isokinetic Balance System
It expresses the equilibrium rate and the probability of falling.
Measured: First Day
CSMI (CYBEX) Humac Norm Isokinetic Test and Exercise System
Measures ankle joint position sensation.
Measured: First day
Berg Balance Scale
It was developed for the evaluation of postural dominance.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: First day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Nov 2023
- Primary completion1 Jan 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Being Between 40-80 Years OldStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Collaborators
- Bolu Izzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital
- Responsible party
- Principal investigator, Fatma Hale Altınkaya, Karabuk University
- Investigators
- Adnan Demirel, Study director, Izzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06043960
- Sponsor's protocol ID
- BAIBÜFTR
- Status last verified
- Mar 2024
- First submitted
- 5 Sep 2023
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Lower Limb Functionality, Foot Joint Position Sensation and Balance in Haemiplegic Patients
- ClinicalTrials.gov ID
- NCT06043960
- Acronym / sponsor ID
- BAIBÜFTR
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Collaborators
- Bolu Izzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with haemiplegia after stroke
Key inclusion criteria (2 listed)
- Individuals aged 40-80 years
- Volunteering to participate in the study
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Humac Norm İsokinetic MachineAlso: Tecno Body Prokin Isokinetic Balance SystemTecno 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 | – |
Primary outcome
Tecno Body Prokin Isokinetic Balance System
Time frame: First Day
It expresses the equilibrium rate and the probability of falling.
CSMI (CYBEX) Humac Norm Isokinetic Test and Exercise System
Time frame: First day
Measures ankle joint position sensation.
Berg Balance Scale
Time frame: First day
It was developed for the evaluation of postural dominance.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adnan Demirel study director
Izzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Being Between 40-80 Years Old and Being Diagnosed With Haemiplegia, run by Karabuk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tecno Body Prokin Isokinetic Balance System (time frame: First Day). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.