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Enrolling by Invitation

NCT Number: NCT07159178

The Effect of Shoulder Problems on Balance in Hemiplegic Patients

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.

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

İstanbul Aydın Unıversity

Istanbul, KÜÇÜKÇEKMECE, 34295, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Shoulder Pain (Visual Analog Scale - VAS)

    Time frame: At baseline (single assessment)

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

Secondary outcomes

  1. Berg Balance Scale

    Time frame: at baseline (single assesment)

    Balance performance will be evaluated using the Berg Balance Scale (BBS). Scores range from 0 to 56, with higher scores indicating better balance ability.

  2. Eularia Health - Eularia Lab

    Time frame: at baseline (single assesment)

    Balance performance will also be assessed using the Eularia Health - Euralia Lab system, which provides objective measurements of postural stability, movement parameters, and dynamic balance control.

Sponsors and collaborators

Lead sponsor

Istanbul Aydın University

Other

Registry information

Official study title

Investigation of the Effect of Shoulder Problems on Balance in Patients With Hemiplegia After Stroke

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 8, 2025
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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