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Effects of Hemiplegic Shoulder Pain on Upper Extremity Motor Function, Trunk Control, Fear of Falling, Mobility and Indepence in Activities of Daily Living in Patients With Stroke

Effects of Hemiplegic Shoulder Pain on Body Structure and Activity in Patients With Stroke

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07559006
Enrollment
62
Registered
2026-04-30
Start date
2026-03-20
Completion date
2026-11-15
Last updated
2026-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

stroke, hemiplegic shoulder pain, trunk control, upper extremity, mobility

Brief summary

This study aimed to examine the effects of hemiplegic shoulder pain on upper extremity motor assessment, trunk control, fear of falling, mobility, and functional indepedence patients with stroke.

Detailed description

The hemiplegic shoulder pain (HSP) in stroke patients is one of the most common complication in acute and subacute stage. Our study consisted of two groups: with and without hemiplegic shoulder pain. The investigators will investigate whether there are differences between the two groups in terms of upper extremity motor assessment, trunk control, fear of falling, mobility, and functional indepedence. Additionally, the investigators will investigate whether there is a correlation between USPRS and other scales (radiologic shoulder assessments and functional outcome measures) in patients with hemiplegic shoulder pain.

Interventions

None listed

Sponsors

Kutahya Health Sciences University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Having a diagnosis of stroke * Aged ≥ 18 years old * Mini Mental State Test score ≥ 24 points * Having a shoulder VAS score of 3 points or higher

Exclusion criteria

* Having another neurological disease (except for stroke * Having communication deficits or neglect * Having a surgery upper or lower extremity in the last 6 months

Design outcomes

Primary

MeasureTime frameDescription
Fugl-Meyer Assessment of Upper ExtremityBaselineFugl-Meyer Assessment scale is an index to assess the sensorimotor impairment in individuals who have had stroke. This scale was first proposed by Axel Fugl-Meyer and his colleagues 1975 as a standardized assessment test for post-stroke recovery in their paper titled "The post-stroke hemiplegic patient: A method for evaluation of physical performance". It is now widely used for clinical assessment of motor function. The Fugl-Meyer Assessment of Upper Extremity motor assessments for the upper (maximum score 66 points) is recommended as core measures to be used in every stroke recovery and rehabilitation trial. Total score is between 0 and 66 points. Higher scores mean a better outcome.
Brunnstrom Recovery Stages of Upper Extremity and HandBaselineThe Brunnstrom recovery stages are a staging system that shows the motor recovery in patients with stroke. The Brunnstrom Recovery Stages of Upper Extremity and Hand consist of six stages. Higher stages indicate better motor function.
Trunk Impairment ScaleBaselineThe Trunk Impairment Scale is a validated clinical tool and measured motor impairment of the trunk after stroke, assessing static/dynamic sitting balance and coordination patient with stroke. Total score is between 0 and 23 points. Higher scores mean a better outcome
Falls Efficacy Scale-InternationalBaselineThe Falls Efficacy Scale-International is a short, easy to administer tool that measures the level of concern about falling during 16 social and physical activities inside and outside the home whether or not the person actually does the activity. The level of concern is measured on a four-point Likert scale (1=not at all concerned to 4=very concerned). Total score is between 16 and 64 points. Lower scores mean a better outcome.
Timed Up and Go TestBaselineThe Timed and Up Go is a general physical performance test used to assess mobility, balance and locomotor performance in elderly people with balance disturbances. More specifically, it assesses the ability to perform sequential motor tasks relative to walking and turning. Patients wear their regular footwear and can use a walking aid, if needed. The patient starts in a seated position The patient stands up upon therapist's command: walks 3 meters, turns around, walks back to the chair and sits down. The time stops when the patient is seated. Be sure to document the assistive device used. The total time to perform this task was measured. The TUG score of 13.5 seconds or longer may indicate an increased risk of falls. A score below 13.5 seconds suggests better functional performance.
Barthel IndexBaselineThe Barthel Index measures the extent to which somebody can function independently and has mobility in their activities of daily living i.e. feeding, bathing, grooming, dressing, bowel control, bladder control, toileting, chair transfer, ambulation and stair climbing. The index also indicates the need for assistance in care. The Barthel Index is a widely used measure of functional disability. The Barthel Index is a 10-item scale (0-100) assessing functional independence in activities of daily living particularly in rehabilitation settings. A higher score indicates greater independence, with 100 representing full independence and 0 representing total dependency. Higher scores mean a better functional dependence.

Secondary

MeasureTime frameDescription
Ultrasound Shoulder Pathology Rating ScaleBaselineThe Ultrasound Shoulder Pathology Rating Scale is a scale based on 5 Ultrasound signs; 3 signs are static and 2 are dynamic. The static tests were greater tuberosity cortical surface irregularity, supraspinatus tendinopathy, and bicipital tendinopathy. The dynamic tests were supraspinatus impingement and subscapularis/biceps/coracoid impingement. A simple ordinal rating scale similar to that used for muscle strength testing was applied to each Ultrasound sign based on the amount of pathology present. The maximum possible score for a shoulder was 20, and the minimum was 0. Higher score indicates a more significant or severe pathology.
Ultrasound Assessment of Acromiohumeral DistanceBaselineThe patient was sitting down and acromiohumeral joint was visualized while the patient's arm was at the side. Then, an image of the bird's beak was obtained by shifting the ultrasound (7 to 15 MHz, Mindray-UMT 200, NJ, United States) probe laterally in the transverse plane, and the linear distance between the humeral head and the acromion was measured.
Shoulder Pain and Disability IndexBaselineThe Shoulder Pain and Disability Index is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. The test takes 5 to 10 minutes for a patient to complete and is the only reliable and valid region-specific measure for the shoulder. A score of 0 indicates best 100 indicates worst. A higher score shows more disability.
Visual Analog ScaleBaselineThe visual analog scale is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." Total score is between 0 and 10 points. Lower scores mean a better outcome
Pressure Pain ThresholdBaselineThe Pressure Pain Threshold is a quantitative sensory test measuring the minimum amount of pressure that triggers a painful sensation, used to evaluate tenderness, deep muscular tissue sensitivity. A higher score on a Pressure Pain Threshold test means it takes more pressure to feel pain, indicating lower sensitivity or higher pain tolerance.
Ultrasound Assessment of Supraspinatus Tendon ThicknessBaselineFor the Supraspinatus Tendon Thickness measure, the participants were seated in an upright position with their feet flat on the floor. Participants were asked to place their tested hand on the ipsilateral iliac crest with the elbow pointed posteriorly (the modified Crass position)

Countries

Turkey (Türkiye)

Contacts

CONTACTLütfiye AKKURT, Assistant Professor
lutfiye.akkurt@ksbu.edu.tr0 (274) 260 00 43
PRINCIPAL_INVESTIGATORAli Çağtay DAYI, MD

Kütahya Health Sciences University

PRINCIPAL_INVESTIGATORGüllü AYDIN-YAĞCIOĞLU, Assoc.Prof.

University of Health Sciences/ Gulhane Campus

PRINCIPAL_INVESTIGATORFatıma YAMAN, Assoc.Prof.

Kütahya Health Sciences University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 14, 2026