NCT04894097

Brief Summary

The purpose of the current study will be focused on the following issues. Evaluation of the effect of magnetic therapy on sonographic findings ,the pressure pain threshold and disability in stroke hemiplegic shoulder.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2025

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

May 16, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 20, 2021

Completed
4.2 years until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2026

Completed
Last Updated

June 24, 2026

Status Verified

June 1, 2026

Enrollment Period

10 months

First QC Date

May 16, 2021

Last Update Submit

June 20, 2026

Conditions

Keywords

pain thrsholdROM

Outcome Measures

Primary Outcomes (1)

  • Sonographic findings

    Shoulder structural changes on the hemiplegic side were evaluated using a Samsung HS70A ultrasonography system (Samsung Medison, Seoul, Korea). Examinations were performed with the patient seated on a chair, and the affected shoulder was systematically scanned. The protocol included assessment of four major tendons long head of the biceps brachii, supraspinatus, infraspinatus, and subscapularis-as well as the glenohumeral joint and the presence of adhesive capsulitis, the latter determined by measuring coracohumeral ligament thickness. Ultrasound (USS) abnormalities were defined as follows. (a) A full-thickness rotator cuff tear was diagnosed when a full-thickness hypoechoic defect was observed, hyaline cartilage was visible, or there was a heterogeneous hypoechoic appearance of the cuff due to deltoid or subacromial-subdeltoid bursal herniation into the tendon. (b) A partial-thickness tear was identified as a hypoechoic defect within the tendon greater than 3 mm, or along the articul

    Baseline

Secondary Outcomes (1)

  • Shoulder range of motion assessment by using magnetic inclinometer

    Baseline

Study Arms (2)

study group

ACTIVE COMPARATOR

Patients will received low frequency high intensity magnetic therapy

Device: magnetic therapy

control group

SHAM COMPARATOR

The patients in this group will be treated by sham magnetic therapy

Device: magnetic therapy

Interventions

High intensity low frequency magnetic therapy

control groupstudy group

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patient's age was between 40 to 50 years old with
  • mild spasticity (grade 1, +1) according to modified Ashworth scale (MAS)
  • All conducted patients experienced a single stroke more than six months with cognitive capacity that enables them to comprehend and follow the instructions (Mini-Mental Scale score \> 24).

You may not qualify if:

  • history of shoulder pain, trauma, or surgery before the stroke; current treatment with warfarin and an international normalized ratio greater than 4.0; use of oral non steroidal anti inflammatory drugs within 3 days before enrolment; or intra articular injections within the previous month. Patients who were unable to report their pain intensity, those with a cardiac pacemaker, and those with clinically significant osteoporosis were also excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university

Cairo, Egypt

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.

MeSH Terms

Conditions

Hemiplegia

Interventions

Magnetic Field Therapy

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Ibrahim A Abu-Ella, MSC

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The patients in control group will be treated by sham radial extracorporeal shock wave therapy in addition to, the same design physical therapy program. Stimulation will not deliver as the transmitter head will be removed. The patients will receive the same frequency of air pressure and
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: * The selected patients will be randomly assigned to two equal groups (study group (GI), and control group (GII). * The study group (GI) will be treated by magnetic therapy in addition to design physical therapy program. * The control group (GII) will be treated by sham magnetic therapy in addition to the same design physical therapy program of (GI).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

May 16, 2021

First Posted

May 20, 2021

Study Start

August 1, 2025

Primary Completion

June 1, 2026

Study Completion

June 18, 2026

Last Updated

June 24, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations