NCT07139665

Brief Summary

This study aims to examine the subacromial space, shoulder pain, and shoulder disability in chronic stroke patients. A total of 60 chronic stroke patients aged 40-65 with similar demographic characteristics are planned to be included in this study. Participants will be selected voluntarily from among chronic stroke patients presenting for routine examination and follow-up at the Neurology Outpatient Clinic of Başkent University Hospital and meeting the appropriate inclusion criteria. Detailed demographic information (age, gender, stroke duration, affected side, etc.) will be recorded for all individuals included in the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

August 18, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 24, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

August 25, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2025

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2025

Completed
Last Updated

November 24, 2025

Status Verified

September 1, 2025

Enrollment Period

2 months

First QC Date

August 18, 2025

Last Update Submit

November 21, 2025

Conditions

Keywords

Subacromial SpaceShoulder PainShoulder Disability Levels

Outcome Measures

Primary Outcomes (3)

  • Ultrasonographic Evaluation

    In this study, ultrasonography will be used to objectively evaluate the subacromial space distance in the shoulder joint in chronic stroke patients.

    Baseline

  • Shoulder Pain and Disability Index

    In this study, the Shoulder Pain and Disability Index will be used to subjectively assess participants' shoulder pain severity and shoulder-related functional limitations. The Shoulder Pain and Disability Index is a widely used, reliable, and valid self-report questionnaire for measuring pain and functional disability in individuals with shoulder problems.

    Baseline

  • Visual Analog Scale

    The Visual Analog Scale is one of the pain rating scales frequently used in epidemiological and clinical studies to measure the intensity or frequency of various symptoms.

    Baseline

Study Arms (1)

Chronic Stroke Patiens

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Chronic Stroke Patients

You may qualify if:

  • Being between the ages of 40 and 65.
  • Scoring 21 or higher on the Montreal Cognitive Assessment Scale (MoCA).
  • Being diagnosed with an ischemic or hemorrhagic stroke by a neurologist and having experienced the stroke for at least 6 months (chronic stroke).
  • Scoring between 0 and 3 on the Modified Rankin Score.
  • Volunteering to participate in the study

You may not qualify if:

  • Difficulty with verbal communication (severe aphasia, cognitive impairment, etc.) that would prevent participation in the study and understanding the test instructions.
  • Severe visual or hearing impairment that would affect test administration or safety.
  • Having another neurological condition (e.g., Parkinson's disease, Multiple Sclerosis, severe peripheral neuropathy) other than stroke that could affect shoulder function or pain.
  • Having a history of shoulder surgery before or after stroke, known rotator cuff tear, shoulder dislocation, severe degenerative joint disease (osteoarthritis), or inflammatory rheumatic disease (e.g., rheumatoid arthritis).
  • Congestive heart failure, uncontrolled hypertension, or other serious cardiopulmonary disease that would preclude physical assessment or have exercise/positioning limitations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baskent University

Ankara, Turkey (Türkiye)

Location

Related Publications (3)

  • Tao W, Fu Y, Hai-Xin S, Yan D, Jian-Hua L. The application of sonography in shoulder pain evaluation and injection treatment after stroke: a systematic review. J Phys Ther Sci. 2015 Sep;27(9):3007-10. doi: 10.1589/jpts.27.3007. Epub 2015 Sep 30.

  • Seitz AL, Michener LA. Ultrasonographic measures of subacromial space in patients with rotator cuff disease: A systematic review. J Clin Ultrasound. 2011 Mar-Apr;39(3):146-54. doi: 10.1002/jcu.20783. Epub 2010 Dec 28.

  • Breckenridge JD, McAuley JH. Shoulder Pain and Disability Index (SPADI). J Physiother. 2011;57(3):197. doi: 10.1016/S1836-9553(11)70045-5.

MeSH Terms

Conditions

StrokeShoulder Pain

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Süleyman Korkusuz, PhD

    Atılım University

    STUDY CHAIR
  • Ali Mert ÖZCAN, MSc

    Baskent University

    STUDY CHAIR
  • Ayşenur ÖZCAN, MSc

    Çankırı Karatekin University

    STUDY CHAIR
  • Sevgi İkbali Afşar, Prof. Dr.

    Baskent University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 18, 2025

First Posted

August 24, 2025

Study Start

August 25, 2025

Primary Completion

October 20, 2025

Study Completion

November 10, 2025

Last Updated

November 24, 2025

Record last verified: 2025-09

Locations