- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07669246
Interoception in Stroke
July 1, 2026 updated by: Çiçek Günday, Istinye University
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.
Study Overview
Status
Recruiting
Conditions
Detailed Description
Participants will not take any intervention.
Study Type
Observational
Enrollment (Estimated)
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 Contact
- Name: Çiçek Günday, Asst. Prof.
- Phone Number: +90 850 283 60 00
- Email: cicek.gunday@istinye.edu.tr
Study Contact Backup
- Name: Hande Ateş
Study Locations
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-
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Istanbul, Turkey (Türkiye)
- Recruiting
- Liv Hospital Topkapi
-
Contact:
- Deputy Chief Physician
- Phone Number: +90 444 66 23
- Email: ik@livhospital.com.tr
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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
No
Sampling Method
Probability Sample
Study Population
Outpatient stroke patients from a university hospital
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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 |
|---|---|---|
|
Interoceptive Accuracy
Time Frame: Day 1
|
Heartbeat Counting Task
|
Day 1
|
|
Proprioception Assessment
Time Frame: Day 1
|
Joint Position Reconstruction Test for the 45 degrees knee flexion.
|
Day 1
|
|
Functional Mobility and Balance
Time Frame: Day 1
|
Timed-up and Go Test
|
Day 1
|
|
Functional Lower Extremity Strength
Time Frame: Day 1
|
5 Times Sit-to-Stand Test
|
Day 1
|
|
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.
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Light Touch Sensation
Time Frame: Day 1
|
Semmes-Weinstein Monofilament Test on the plantar surface of the foot
|
Day 1
|
|
Subjective Pain
Time Frame: Day 1
|
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.
|
Day 1
|
|
Fear of Falling
Time Frame: Day 1
|
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).
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Orge Fatoş Demirtaş, Topkapi Liv Hospital
- Study Chair: Mona Abualkas, Istinye University
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 (Estimated)
June 20, 2026
Primary Completion (Estimated)
December 25, 2026
Study Completion (Estimated)
December 25, 2026
Study Registration Dates
First Submitted
June 15, 2026
First Submitted That Met QC Criteria
June 24, 2026
First Posted (Actual)
June 25, 2026
Study Record Updates
Last Update Posted (Actual)
July 2, 2026
Last Update Submitted That Met QC Criteria
July 1, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 150620262
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.