NCT07669246

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
5mo left

Started Jun 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress24%
Jun 2026Dec 2026

First Submitted

Initial submission to the registry

June 15, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

June 20, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 25, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2026

Last Updated

July 2, 2026

Status Verified

July 1, 2026

Enrollment Period

6 months

First QC Date

June 15, 2026

Last Update Submit

July 1, 2026

Conditions

Keywords

Plantar sensationJoint position senseFear of falling

Outcome Measures

Primary Outcomes (5)

  • 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.

    Day 1

  • Interoceptive Accuracy

    Heartbeat Counting Task

    Day 1

  • Proprioception Assessment

    Joint Position Reconstruction Test for the 45 degrees knee flexion.

    Day 1

  • Functional Mobility and Balance

    Timed-up and Go Test

    Day 1

  • Functional Lower Extremity Strength

    5 Times Sit-to-Stand Test

    Day 1

Secondary Outcomes (3)

  • Light Touch Sensation

    Day 1

  • Subjective Pain

    Day 1

  • Fear of Falling

    Day 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Outpatient stroke patients from a university hospital

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liv Hospital Topkapi

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Orge Fatoş Demirtaş

    Topkapi Liv Hospital

    STUDY CHAIR
  • Mona Abualkas

    Istinye University

    STUDY CHAIR

Central Study Contacts

Çiçek Günday, Asst. Prof.

CONTACT

Hande Ateş

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof

Study Record Dates

First Submitted

June 15, 2026

First Posted

June 25, 2026

Study Start

June 20, 2026

Primary Completion (Estimated)

December 25, 2026

Study Completion (Estimated)

December 25, 2026

Last Updated

July 2, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations