The Effect of Shoulder Problems on Balance in Hemiplegic Patients

NCT ID: NCT07159178

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-07
• Study Completion Date: 2025-11-07

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.

Detailed Description

Hemiplegia is one of the most frequent clinical outcomes after stroke and is commonly accompanied by shoulder problems, which are a major cause of impaired biomechanics. Shoulder function plays a key role in transfers, maintaining postural stability during ambulation, and ensuring effective hand and self-care functions. Impaired shoulder biomechanics may cause a feeling of insecurity, abnormal gait disturbances, and balance deficits.

The primary objective of this study is to evaluate the effect of shoulder problems on balance in hemiplegic patients. Inclusion criteria were: first-ever diagnosis of stroke, Mini Mental State Examination score ≥24, voluntary participation, literacy, absence of visual impairment, and age between 40-75 years. Participants signed informed consent forms and completed a demographic data form including sex, age, height, weight, education level, medical and family history, smoking status, other comorbidities, affected side, and duration of hemiplegia.

Hemiplegic patients were divided into two groups: those with shoulder pain and those without. Shoulder pain was assessed using the Visual Analog Scale (VAS). Shoulder joint range of motion was measured with the Senso4Motion device. Balance performance was evaluated using the Berg Balance Scale and the Senso4Motion system. By comparing patients with and without shoulder pain, this study aims to clarify the impact of shoulder problems on post-stroke balance, thereby contributing to rehabilitation strategies and improving functional outcomes

Conditions

Hemiplegia; Stroke

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul Aydın University

OTHER

Sponsor Role: lead

Responsible Party

EDA SALGUT

principal ınvestigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

GÖKHAN ÖZKOÇAK, M.D.

Role: STUDY_CHAIR

İSTANBUL AYDIN UNIVERSITY

İBRAHİM HALİL URAL, M.D

Role: STUDY_CHAIR

İstanbul Beykent Unıversıty

ARZU DİNÇ YAVAŞ, M.D

Role: STUDY_CHAIR

Istanbul Aydın University

eda salgut, PT

Role: PRINCIPAL_INVESTIGATOR

İSTANBUL AYDIN UNIVERSITY

Locations

İstanbul Aydın Unıversity

Istanbul, KÜÇÜKÇEKMECE, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

IstanbuIAU

Identifier Type: -

Identifier Source: org_study_id