NCT05828797

Brief Summary

In our study, we aimed to examine the muscles and tendons of the shoulder region on the plegic side of patients with hemiplegia by elastography and to investigate whether there is a relationship between the course of the disease and the course of the lesions that will occur in the shoulder.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 25, 2023

Completed
1 year until next milestone

Study Start

First participant enrolled

May 5, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

May 7, 2024

Status Verified

May 1, 2024

Enrollment Period

8 months

First QC Date

April 12, 2023

Last Update Submit

May 4, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evaluation of Shoulder Region With Share-Wave Ultrasound Elastography in Patients With Hemiplegia

    Hemiplegia

    02/05/2023-02/05/2024

Study Arms (2)

Shoulder elastography on the hemiplegic side of patients

Patients over the age of 18 who apply to our clinic and have hemiplegia complaints will be evaluated. Patients' age, gender, occupation, habits, disease duration, upper extremity with complaints, dominant upper extremity, additional disease, weight and height values will be recorded. In the physical medicine and rehabilitation department examination of the patients, the patients will be evaluated with the brunnstrom staging used in hemiplegic patients. The elastography of the shoulder on the side with hemiplegia and the elastography of the shoulder on the side without complaints will be examined. Thus, the patient's side with the complaint will be checked by comparing the healthy side.

Shoulder elastography on the non-hemiplegia side of patients

Patients over the age of 18 who apply to our clinic and have hemiplegia complaints will be evaluated. Patients' age, gender, occupation, habits, disease duration, upper extremity with complaints, dominant upper extremity, additional disease, weight and height values will be recorded. In the physical medicine and rehabilitation department examination of the patients, the patients will be evaluated with the brunnstrom staging used in hemiplegic patients. The elastography of the shoulder on the side with hemiplegia and the elastography of the shoulder on the side without complaints will be examined. Thus, the patient's side with the complaint will be checked by comparing the healthy side.

Eligibility Criteria

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

Patients over the age of 18 who apply to our clinic and have hemiplegia complaints will be evaluated.

You may qualify if:

  • Volunteer patients
  • Patients over 18 years old
  • Patients with hemiplegia
  • Patients without any rheumatic disease
  • Patients without any neurological deficit and muscle disease
  • Not having received ftr treatment to the shoulder area in the last 3 months
  • No injection to the shoulder area in the last 3 months
  • Not having any surgical procedure on the shoulder area
  • Not to be pregnant

You may not qualify if:

  • Patients with any rheumatic disease
  • Patients with any neurological deficit and muscle disease
  • To have received ftr treatment to the shoulder area in the last 3 months
  • Being under 18 years old
  • Having an infectious disease
  • Having any benign or malignant disease
  • Any surgical procedure to the shoulder area
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harran University Faculty of Medicine, Department of Physical Medicine and Rehabilitation, Şanlıurfa

Sanliurfa, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Hemiplegia

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 12, 2023

First Posted

April 25, 2023

Study Start

May 5, 2024

Primary Completion

January 1, 2025

Study Completion

January 1, 2026

Last Updated

May 7, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations