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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04738253
Other study ID # 2020-10-015-002
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 7, 2020
Est. completion date December 31, 2021

Study information

Verified date February 2021
Source Yeungnam University Hospital
Contact Dong Gyu Lee, M.D., Ph.D.
Phone 21099111448
Email Painfree@yu.ac.kr
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Limitation of range of motion in the shoulder joints is common in stroke patients. The causes are stiffness, CRPS, and frozen shoulder. The purpose of this study was to investigate the relationship between frozen shoulder and shoulder LOM in patients with cerebral infarction using ultrasonography.


Description:

Ultrasound examination was performed on 50 patients with limited range of motion of the shoulder joint among inpatients or outpatients in the Department of Rehabilitation Medicine of our hospital, who had a stroke of fewer than 2 years, and the findings suitable for adhesive capsulitis, namely the thickness of the joint capsule in the axillary concave Identify those with thickened findings. Their shoulder power rating, passive range of motion, stiffness evaluation (Modified Ashworth Scale, MAS), and the presence or absence of Reflex Sympathetic Dystrophy (RSD) were evaluated, and the relationship with ultrasound findings was investigated.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: - Those who have been diagnosed with a stroke through CT or MRI within the last 2 years - Those who are over 19 years old - Those who have limitations in the range of motion of the shoulder joint Exclusion Criteria: - Those diagnosed with adhesive arthritis prior to the onset of stroke - Patients with a severe shoulder trauma - Those who performed shoulder surgery

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Ultrasonography
The ultrasound measurement s of the axillary recess capsule thickness.

Locations

Country Name City State
Korea, Republic of Yeungnam University Hospital Daegu

Sponsors (1)

Lead Sponsor Collaborator
Yeungnam University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Range of motion of shoulder joint A goniometer is an instrument which measures the available range of motion at a joint.Flexion, Extension,Adduction,Abduction, Internal Rotation,External rotation day 1
Secondary MAS(Modified Ashworth Scale) of elbow Flexor The Modified Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension). day 1
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