The Effect of Shoulder Problems on Balance in Hemiplegic Patients

NCT07159178 | Enrolling By Invitation

• 1 other identifier: IstanbuIAU
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Shoulder problems are among the most common complications in hemiplegic patients and may impair shoulder biomechanics, negatively affecting mobility, transfers, and self-care. This study aims to investigate whether shoulder problems influence balance in hemiplegic patients after stroke. Patients with a first-ever stroke diagnosis, sufficient cognitive function (Mini Mental State Examination score ≥24), no visual impairments, and aged between 40-75 years were included. Hemiplegic patients with shoulder pain formed the first group, while those without shoulder pain formed the second group. Shoulder pain was assessed using the Visual Analog Scale (VAS), shoulder range of motion with the Senso4Motion device, and balance level with both the Berg Balance Scale and Senso4Motion.

Conditions

Hemiplegia; Stroke

Keywords

Hemiplegia; Stroke; Shoulder Pain; Balance; postural control

Outcome Measures

Primary Outcomes (1)

• Shoulder Pain (Visual Analog Scale - VAS)

  Shoulder pain will be assessed using a 10-cm Visual Analog Scale (VAS), where 0 indicates "no pain" and 10 indicates "worst imaginable pain".

  At baseline (single assessment)

Secondary Outcomes (2)

• Berg Balance Scale

  at baseline (single assesment)

• Eularia Health - Eularia Lab

  at baseline (single assesment)

Study Arms (1)

Hemiplegic Patients With and Without Shoulder Pain

This group includes hemiplegic patients after stroke. Participants were divided into two subgroups according to the presence or absence of shoulder pain. Assessments included pain, balance, and shoulder joint range of motion.

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of hemiplegic patients aged 40 to 80 years who experienced a first-ever stroke. Participants were recruited from \[insert hospital/clinic name, e.g., Istanbul Aydın University affiliated hospitals/outpatient clinics\]. Eligible patients had stable vital signs, adequate cognitive function (MMSE ≥ 24), and the ability to read and write. Patients were divided into subgroups according to the presence or absence of shoulder problems

You may qualify if:

• Voluntary participation with signed informed consent Ability to read and write Age between 40 and 80 years First-ever stroke diagnosis Stable vital signs

You may not qualify if:

• Diagnosis of any neurological or psychiatric disorder other than stroke Presence of visual or speech impairments History of more than one stroke

Sponsors & Collaborators

• Istanbul Aydın University: lead

Study Sites (1)

İstanbul Aydın Unıversity

Istanbul, KÜÇÜKÇEKMECE, 34295, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hemiplegia; Stroke; Shoulder Pain

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain

Study Officials

• GÖKHAN ÖZKOÇAK, M.D.

  İSTANBUL AYDIN UNIVERSITY

  STUDY CHAIR

• İBRAHİM HALİL URAL, M.D

  İstanbul Beykent Unıversıty

  STUDY CHAIR

• ARZU DİNÇ YAVAŞ, M.D

  Istanbul Aydın University

  STUDY CHAIR

• eda salgut, PT

  İSTANBUL AYDIN UNIVERSITY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal ınvestigator

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: September 8, 2025
• Study Start: September 7, 2025
• Primary Completion: October 7, 2025
• Study Completion: November 7, 2025
• Last Updated: September 8, 2025

Record last verified: 2025-08

Locations

TU (1)