StrokeNCT07669246
Interoception in Stroke
An observational study of Stroke, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to examine the associations of interoceptive awareness and interoceptive accuracy with plantar superficial sensory threshold, knee joint proprioception, pain intensity, and dynamic balance performance in cognitively intact individuals with chronic hemiplegia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jun 2026to 25 Dec 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatient stroke patients from a university hospital
Who may be able to join
- Presence of hemiplegia due to a physician-diagnosed stroke,
- At least 6 months have passed since the stroke,
- Voluntary agreement to participate in the study.
Who cannot join
- History of traumatic brain injury, brain tumor, meningitis, or secondary neurological disease,
- Having experienced a cardiovascular event or any acute medical condition within the last 3 months,
- Insufficient visual or auditory ability to understand the questionnaires and tests.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hande Ateş contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Liv Hospital Topkapi
Istanbul
Deputy Chief Physician, +90 444 66 23, ik@livhospital.com.tr
About this study
Official title: Association of Interoception With Somatosensory Function, Proprioception, and Balance in Patients With Hemiplegia
This study aims to examine the associations of interoceptive awareness and interoceptive accuracy with plantar superficial sensory threshold, knee joint proprioception, pain intensity, and dynamic balance performance in cognitively intact individuals with chronic hemiplegia.
Hypotheses are:
- H0: There is no significant relationship between interoception and light touch, proprioception, pain, or dynamic balance performance in cognitively intact individuals with chronic hemiplegia.
- H1: There is a significant relationship between interoception and light touch, proprioception, pain, or dynamic balance performance in cognitively intact individuals with chronic hemiplegia All participants will undergo a single assessment session and will not be invited for any treatment or follow-up evaluation. Participants will not take any intervention.
Read the detailed description
Participants will not take any intervention.
- Conditions
- Stroke
- Keywords
- Plantar sensation, Joint position sense, Fear of falling
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Interoceptive Awareness
The Multidimensional Assessment of Interoceptive Awareness Version 2 (MAIA-2) consists of eight subscales, each scored from 0 to 5. Higher scores indicate greater interoceptive awareness in the corresponding domain.
Measured: Day 1
Interoceptive Accuracy
Heartbeat Counting Task
Measured: Day 1
Proprioception Assessment
Joint Position Reconstruction Test for the 45 degrees knee flexion.
Measured: Day 1
Functional Mobility and Balance
Timed-up and Go Test
Measured: Day 1
Functional Lower Extremity Strength
5 Times Sit-to-Stand Test
Measured: Day 1
Secondary outcomes (3)
Light Touch Sensation
Semmes-Weinstein Monofilament Test on the plantar surface of the foot
Measured: Day 1
Subjective Pain
The Numeric Rating Scale for Lower Extremity Pain Severity is an 11-point scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate greater pain severity.
Measured: Day 1
Fear of Falling
The Falls Efficacy Scale-International (FES-I) consists of 16 items, with a total score ranging from 16 to 64. Higher scores indicate greater concern about falling (greater fear of falling).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start20 Jun 2026 (estimated)
- Primary completion25 Dec 2026 (estimated)
- Study completion25 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Çiçek Günday, Istinye University
- Investigators
- Orge Fatoş Demirtaş, Study chair, Topkapi Liv HospitalMona Abualkas, Study chair, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07669246
- Sponsor's protocol ID
- 150620262
- Status last verified
- Jul 2026
- First submitted
- 15 Jun 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Interoception With Somatosensory Function, Proprioception, and Balance in Patients With Hemiplegia
- ClinicalTrials.gov ID
- NCT07669246
- Acronym / sponsor ID
- 150620262
- Conditions
- Stroke
- Keywords
- Plantar sensation, Joint position sense, Fear of falling
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 20 Jun 2026 (estimated)
- Primary completion
- 25 Dec 2026 (estimated)
- Study completion
- 25 Dec 2026 (estimated)
- First posted
- 25 Jun 2026 (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.
This study aims to examine the associations of interoceptive awareness and interoceptive accuracy with plantar superficial sensory threshold, knee joint proprioception, pain intensity, and dynamic balance performance in cognitively intact individuals with chronic hemiplegia.
Hypotheses are:
- H0: There is no significant relationship between interoception and light touch, proprioception, pain, or dynamic balance performance in cognitively intact individuals with chronic hemiplegia.
- H1: There is a significant relationship between interoception and light touch, proprioception, pain, or dynamic balance performance in cognitively intact individuals with chronic hemiplegia All participants will undergo a single assessment session and will not be invited for any treatment or follow-up evaluation. Participants will not take any intervention.
Detailed description
Participants will not take any intervention.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatient stroke patients from a university hospital
Key inclusion criteria (3 listed)
- Presence of hemiplegia due to a physician-diagnosed stroke,
- At least 6 months have passed since the stroke,
- Voluntary agreement to participate in the study.
Key exclusion criteria (3 listed)
- History of traumatic brain injury, brain tumor, meningitis, or secondary neurological disease,
- Having experienced a cardiovascular event or any acute medical condition within the last 3 months,
- Insufficient visual or auditory ability to understand the questionnaires and tests.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Interoceptive Awareness
Time frame: Day 1
The Multidimensional Assessment of Interoceptive Awareness Version 2 (MAIA-2) consists of eight subscales, each scored from 0 to 5. Higher scores indicate greater interoceptive awareness in the corresponding domain.
Interoceptive Accuracy
Time frame: Day 1
Heartbeat Counting Task
Proprioception Assessment
Time frame: Day 1
Joint Position Reconstruction Test for the 45 degrees knee flexion.
Functional Mobility and Balance
Time frame: Day 1
Timed-up and Go Test
Functional Lower Extremity Strength
Time frame: Day 1
5 Times Sit-to-Stand Test
3 secondary outcomes
Light Touch Sensation
Time frame: Day 1
Subjective Pain
Time frame: Day 1
Fear of Falling
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Hande Ateş contact
Orge Fatoş Demirtaş study chair
Topkapi Liv Hospital
Mona Abualkas study chair
Istinye University
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 Stroke, run by Istinye 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 2 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Çiçek Günday, Asst. Prof. (+90 850 283 60 00, cicek.gunday@istinye.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interoceptive Awareness (time frame: Day 1). The study lists 5 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 Jul 2026.