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

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.

Study Overview

• Status: Recruiting
• Conditions: 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.

• Study Type: Observational
• Enrollment (Estimated): 62

Contacts and Locations

• Study Contact: Name: Lütfiye AKKURT, Assistant Professor; Phone Number: 1446 0 (274) 260 00 43; Email: lutfiye.akkurt@ksbu.edu.tr

Study Locations

• Turkey (Türkiye)
  • Kütahya
    • Kütahya, Kütahya, Turkey (Türkiye), 43100
      • Recruiting
      • Kutahya Health Sciences University
      • Contact: Lütfiye AKKURT, Asst.Prof.; Phone Number: 1446 +90 (274) 260 00 43; Email: lutfiye.akkurt@ksbu.edu.tr
      • Contact: Fatıma YAMAN, Assoc.Prof.; Phone Number: +90 (274) 260 00 43; Email: fatima.yaman@ksbu.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with stroke

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
With Hemiplegic Shoulder Pain in Stroke Patients
Without Hemiplegic Shoulder Pain in Stroke Patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fugl-Meyer Assessment of Upper Extremity	Fugl-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.	Baseline
Brunnstrom Recovery Stages of Upper Extremity and Hand	The 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.	Baseline
Trunk Impairment Scale	The 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	Baseline
Falls Efficacy Scale-International	The 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.	Baseline
Timed Up and Go Test	The 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.	Baseline
Barthel Index	The 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.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ultrasound Shoulder Pathology Rating Scale	The 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.	Baseline
Ultrasound Assessment of Acromiohumeral Distance	The 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.	Baseline
Shoulder Pain and Disability Index	The 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.	Baseline
Visual Analog Scale	The 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	Baseline
Pressure Pain Threshold	The 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.	Baseline
Ultrasound Assessment of Supraspinatus Tendon Thickness	For 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)	Baseline

Collaborators and Investigators

• Sponsor: Kutahya Health Sciences University
• Investigators: Principal Investigator: Ali Çağtay DAYI, MD, Kutahya Health Sciences University; Principal Investigator: Güllü AYDIN-YAĞCIOĞLU, Assoc.Prof., University of Health Sciences/ Gulhane Campus; Principal Investigator: Fatıma YAMAN, Assoc.Prof., Kutahya Health Sciences University

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2026
• Primary Completion (Estimated): October 25, 2026
• Study Completion (Estimated): November 15, 2026

Study Registration Dates

• First Submitted: April 13, 2026
• First Submitted That Met QC Criteria: April 26, 2026
• First Posted (Actual): April 30, 2026

Study Record Updates

• Last Update Posted (Actual): August 13, 2026
• Last Update Submitted That Met QC Criteria: August 11, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: stroke; mobility; upper extremity; hemiplegic shoulder pain; trunk control
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: 2026/03-32

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No