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

NCT07559006 | Recruiting

• 1 other identifier: 2026/03-32
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

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

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (6)

• Ultrasound Shoulder Pathology Rating Scale

  Baseline

• Ultrasound Assessment of Acromiohumeral Distance

  Baseline

• Shoulder Pain and Disability Index

  Baseline

• Visual Analog Scale

  Baseline

• Pressure Pain Threshold

  Baseline

Study Arms (2)

With Hemiplegic Shoulder Pain in Stroke Patients

Without Hemiplegic Shoulder Pain in Stroke Patients

Eligibility Criteria

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

Study Population

Patients with stroke

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

Study Sites (1)

Kütahya Health Sciences University

Kütahya, Kütahya, 43100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ali Çağtay DAYI, MD

  Kütahya Health Sciences University

  PRINCIPAL INVESTIGATOR

• Güllü AYDIN-YAĞCIOĞLU, Assoc.Prof.

  University of Health Sciences/ Gulhane Campus

  PRINCIPAL INVESTIGATOR

• Fatıma YAMAN, Assoc.Prof.

  Kütahya Health Sciences University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lütfiye AKKURT, Assistant Professor

CONTACT

0 (274) 260 00 43; lutfiye.akkurt@ksbu.edu.tr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 30, 2026
• Study Start: March 20, 2026
• Primary Completion (Estimated): August 25, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

TU (1)