Haemiplegic PatientsNCT05973279
The Relationship Between Lower Limb Functionality, Knee Joint Position Sense, Balance and Falls in Haemiplegic Patients
An observational study of Haemiplegic Patients and Balance, run by Karabuk University.
Trial summary
Stroke is defined as a neurological disorder attributed to acute focal damage of the central nervous system from a vascular cause, including cerebral infarction, intracerebral haemorrhage and subarachnoid haemorrhage. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Haemiplegic Patients, Balance, Knee Joint Position Sensation
- What is being tested?
- Tecno Body Prokin Isokinetic Balance System, Restorative Therapies RT300 leg/arm/cor: and CSMI (CYBEX) Humac Norm Isokinetic Test and Exercise System
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 1 Jun 2024
- How long will I take part?
- 1 Year
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hemiplegic patients
Who may be able to join
- Individuals over 18 years of age
- Volunteering to participate in the study
Who cannot join
- Hip and knee prosthesis
- 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
No sites are listed yet.
About this study
Stroke is defined as a neurological disorder attributed to acute focal damage of the central nervous system from a vascular cause, including cerebral infarction, intracerebral haemorrhage and subarachnoid haemorrhage. The World Health Organisation defines stroke as a focal and sometimes global impairment of cerebral function that lasts longer than 24 hours or ends in death, develops rapidly, has no demonstrable cause other than a vascular cause. Evaluation of muscle strength and balance ability of affected patients is critical for the recovery of lower extremity motor functions.
Proprioception encompasses various sensory perception modalities such as force, effort, movement and limb position. Impairment of sensory function in patients with haemiplegia can hinder the ability of muscles to recover during walking. Accurate and effective assessment of gait and balance functions and their subsequent improvement is one of the primary goals of stroke rehabilitation programmes. Studies comparing the effects of lower extremity functionality and knee joint position sense on balance and falls are available in various versions in the literature. However, there is no study in which 'Restorative Therapies RT300 leg/arm/cor' device was used to measure functionality, 'Humac Norm Isokinetic Machine' was used to measure knee joint position sense, and 'Tecno Body Prokin Isokinetic Balance System' was used to measure balance in a single simultaneous study. Therefore, the aim of this study was to investigate the relationship between lower limb functionality and knee joint position sense with balance and fall parameters in patients with hemiplegia using various devices.
- Being tested
- Tecno Body Prokin Isokinetic Balance System, Restorative Therapies RT300 leg/arm/cor:, CSMI (CYBEX) Humac Norm Isokinetic Test and Exercise System
- Keywords
- Proprioception, Joint Position Sense, Hemiplegia, Lower Limb Functionality, Balance, Fall
- Medical subject headings
- Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tecno Body Prokin Isokinetic Balance SystemOther
It provides objectively measurable data in static and dynamic balance measurements. The moving balance platform of the system, which is driven by air piston servo motors, can measure at a working angle of 15 degrees in all directions. The results can be monitored and recorded live on the screen on the device. From these data, each individual's static and dynamic balance score is obtained by summing the forward-backward standard deviation and right-left standard deviation.
Restorative Therapies RT300 leg/arm/cor:Other
RT300 is a motorised treatment system. In general there are 3 systems; Passive therapy, Active therapy and a combination of active therapy with some assistance from the motor. The device can be used from a chair, wheelchair or bed and there are two variants that can be used separately; Leg system, Arm system. Electrodes placed on the skin over specific muscle groups are connected via a cable or wirelessly to the RT300. These are used to stimulate peripheral motor nerves, causing the muscles to work. The software of the SAGE controller unit of the RT300 monitors the treatment process, including the stimulation patterns sent to the arms or legs, and the operation of the ergometer motor to produce smooth cycling motion. Contraindicated in the presence of lower limb fractures or pregnancy.
CSMI (CYBEX) Humac Norm Isokinetic Test and Exercise SystemOther
22 isolated joint movement models, 4 resistance modes (isokinetic, isotonic, isometric and passive) and a large number of reports to meet the measurement and exercise needs of today's clinicians and researchers. The exercise modes of the device include; Continuous passive movement, multi-angle isometry, proprioception training, standard and eccentric focused isokinetic strengthening, deceleration training, dynamic isotonic training, strength training. Test modes of the device include; Proprioceptive, co-measured, standard isokinetic, concentric/eccentric isokinetic, intermittent stroke isokinetic test.
| Study group | Role | What they receive |
|---|---|---|
| Hemiplegic patients | Not described Receives: Other: Tecno Body Prokin Isokinetic Balance System; Other: Restorative Therapies RT300 leg/arm/cor:; Other: CSMI (CYBEX) Humac Norm Isokinetic Test and Exercise System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance and knee joint position
Knee joint position sense is related to balance in haemiplegic patients.
Measured: First day
Lower extremity functionality and balance
In haemiplegic patients, the level of lower extremity functionality is related to balance.
Measured: First day
Falling and knee joint position
Knee joint position sense is associated with falls in haemiplegic patients.
Measured: First day
Lower extremity functionality and falling
Lower extremity functionality is associated with falls in haemiplegic patients.
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 posted2 Aug 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Haemiplegic PatientsStudies 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 (estimated)
- Target duration
- 1 Year
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
- NCT05973279
- Sponsor's protocol ID
- KarabukUNI
- Status last verified
- Sep 2023
- First submitted
- 26 Jul 2023
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Lower Limb Functionality, Knee Joint Position Sense, Balance and Falls in Haemiplegic Patients
- ClinicalTrials.gov ID
- NCT05973279
- Acronym / sponsor ID
- KarabukUNI
- Keywords
- Proprioception, Joint Position Sense, Hemiplegia, Lower Limb Functionality, Balance, Fall
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Collaborators
- Bolu Izzet Baysal Physiotherapy and Rehabilitation Training and Research Hospital
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 2 Aug 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 attributed to acute focal damage of the central nervous system from a vascular cause, including cerebral infarction, intracerebral haemorrhage and subarachnoid haemorrhage. The World Health Organisation defines stroke as a focal and sometimes global impairment of cerebral function that lasts longer than 24 hours or ends in death, develops rapidly, has no demonstrable cause other than a vascular cause. Evaluation of muscle strength and balance ability of affected patients is critical for the recovery of lower extremity motor functions.
Proprioception encompasses various sensory perception modalities such as force, effort, movement and limb position. Impairment of sensory function in patients with haemiplegia can hinder the ability of muscles to recover during walking. Accurate and effective assessment of gait and balance functions and their subsequent improvement is one of the primary goals of stroke rehabilitation programmes. Studies comparing the effects of lower extremity functionality and knee joint position sense on balance and falls are available in various versions in the literature. However, there is no study in which 'Restorative Therapies RT300 leg/arm/cor' device was used to measure functionality, 'Humac Norm Isokinetic Machine' was used to measure knee joint position sense, and 'Tecno Body Prokin Isokinetic Balance System' was used to measure balance in a single simultaneous study. Therefore, the aim of this study was to investigate the relationship between lower limb functionality and knee joint position sense with balance and fall parameters in patients with hemiplegia using various devices.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemiplegic patients | – | Other: Tecno Body Prokin Isokinetic Balance System, Other: Restorative Therapies RT300 leg/arm/cor:, Other: CSMI (CYBEX) Humac Norm Isokinetic Test and Exercise System |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hemiplegic patients
Key inclusion criteria (2 listed)
- Individuals over 18 years of age
- Volunteering to participate in the study
Key exclusion criteria (5 listed)
- Hip and knee prosthesis
- 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 |
|---|---|---|
| Tecno Body Prokin Isokinetic Balance SystemIt provides objectively measurable data in static and dynamic balance measurements. The moving balance platform of the system, which is driven by air piston servo motors, can measure at a working angle of 15 degrees in all directions. The results can be monitored and recorded live on the screen on the device. From these data, each individual's static and dynamic balance score is obtained by summing the forward-backward standard deviation and right-left standard deviation. | Other | Hemiplegic patients |
| Restorative Therapies RT300 leg/arm/cor:RT300 is a motorised treatment system. In general there are 3 systems; Passive therapy, Active therapy and a combination of active therapy with some assistance from the motor. The device can be used from a chair, wheelchair or bed and there are two variants that can be used separately; Leg system, Arm system. Electrodes placed on the skin over specific muscle groups are connected via a cable or wirelessly to the RT300. These are used to stimulate peripheral motor nerves, causing the muscles to work. The software of the SAGE controller unit of the RT300 monitors the treatment process, including the stimulation patterns sent to the arms or legs, and the operation of the ergometer motor to produce smooth cycling motion. Contraindicated in the presence of lower limb fractures or pregnancy. | Other | Hemiplegic patients |
| CSMI (CYBEX) Humac Norm Isokinetic Test and Exercise System22 isolated joint movement models, 4 resistance modes (isokinetic, isotonic, isometric and passive) and a large number of reports to meet the measurement and exercise needs of today's clinicians and researchers. The exercise modes of the device include; Continuous passive movement, multi-angle isometry, proprioception training, standard and eccentric focused isokinetic strengthening, deceleration training, dynamic isotonic training, strength training. Test modes of the device include; Proprioceptive, co-measured, standard isokinetic, concentric/eccentric isokinetic, intermittent stroke isokinetic test. | Other | Hemiplegic patients |
Primary outcome
Balance and knee joint position
Time frame: First day
Knee joint position sense is related to balance in haemiplegic patients.
Lower extremity functionality and balance
Time frame: First day
In haemiplegic patients, the level of lower extremity functionality is related to balance.
Falling and knee joint position
Time frame: First day
Knee joint position sense is associated with falls in haemiplegic patients.
Lower extremity functionality and falling
Time frame: First day
Lower extremity functionality is associated with falls in haemiplegic patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Individual participant dataSharing planned: Undecided
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
Questions about this trial
What is this clinical trial studying?
An observational study of Haemiplegic Patients and Balance, run by Karabuk University.
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 5 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: status not confirmed, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fatma Hale Altınkaya (05312013899, f.hale.altinkaya@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance and knee joint position (time frame: First day). The study lists 4 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 7 Sep 2023.