NCT06793852

Brief Summary

The main purpose of this study is to reveal the effects of shoulder pain in chronic hemiplegic patients with a more comprehensive and holistic perspective through evaluation and correlation methods. It is thought that these evaluations can make significant contributions to the understanding of the etiology and treatment of post-stroke shoulder pain. The focus of the study is to deeply examine the effects of shoulder pain on joint position sense, postural control, tactile sense and muscle strength in chronic hemiplegic patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 27, 2025

Completed
29 days until next milestone

Study Start

First participant enrolled

February 25, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2025

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2025

Completed
Last Updated

December 22, 2025

Status Verified

January 1, 2025

Enrollment Period

4 months

First QC Date

January 21, 2025

Last Update Submit

December 15, 2025

Conditions

Keywords

StrokePainPostural ControlSensationMuscle Strength

Outcome Measures

Primary Outcomes (5)

  • inclinometer

    Baseline

  • Postural Assessment Scale for Stroke Patients (PASS-T)

    Baseline

  • Semmes-Weinstein Monofilament test

    Baseline

  • dynamometer

    Baseline

  • pinchmeter

    Baseline

Secondary Outcomes (3)

  • Personal information form

    Baseline

  • Visual Analog Scale

    Baseline

  • Shoulder Pain and Disability Index

    Baseline

Study Arms (2)

participants with shoulder pain

participants without shoulder pain

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population will consist of individuals diagnosed with stroke and receiving treatment at the Special Safranbolu Special Education and Rehabilitation Center in Karabük province. Based on previous similar studies, the sample size was calculated using power analysis with 80% power and a significance level of α=0.05, resulting in 78 participants.

You may qualify if:

  • At least 3 months post-stroke, diagnosis of hemiplegia after stroke, aged 18 or older, having cognitive abilities and cooperation required to fulfill the study requirements, and willingness to participate in the study.

You may not qualify if:

  • cognitive impairment interfering with informed consent or adherence to study assessments, aphasia, the presence of major neurological or rheumatological diseases affecting the musculoskeletal system other than stroke, and a history of surgery on the affected shoulder prior to stroke.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karabük University

Karabük, Turkey (Türkiye)

Location

Related Publications (1)

  • Wilson RD, Chae J. Hemiplegic Shoulder Pain. Phys Med Rehabil Clin N Am. 2015 Nov;26(4):641-55. doi: 10.1016/j.pmr.2015.06.007. Epub 2015 Sep 9.

    PMID: 26522903BACKGROUND

MeSH Terms

Conditions

StrokePain

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, PT, PhD

Study Record Dates

First Submitted

January 21, 2025

First Posted

January 27, 2025

Study Start

February 25, 2025

Primary Completion

June 20, 2025

Study Completion

June 25, 2025

Last Updated

December 22, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations