Correlation Between Ultrasonography Finding and Shoulder... | NCT04738253

Studies
Correlation Between Ultrasonography Finding and Shoulder Range of Motion in Stroke Patients

NCT04738253

Sponsor

Yeungnam University Hospital

Status

Unknown status

Last Update Posted

Feb 17, 2021Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Cerebral Stroke
Frozen Shoulder

Interventions

Ultrasonography

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 7, 2020Actual

Primary Completion Date

Dec 31, 2021Estimated

Completion Date

Dec 31, 2021Estimated

First Submitted Date

Jan 31, 2021

First Submission Date that Met QC Criteria

Feb 3, 2021

First Posted Date

Feb 4, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 15, 2021

Last Update Posted Date

Feb 17, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dong Gyu Lee, Assistant professor, Yeungnam University HospitalPrincipal Investigator

Lead Sponsor

Yeungnam University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study group		Stroke patients with limitation of range of motion on the affected shoulder.	Diagnostic Test: Ultrasonography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasonography	Diagnostic Test	The ultrasound measurement s of the axillary recess capsule thickness.	Study group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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).

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

the cerebral stroke patients with limitation of range of motion on affected shoulder.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dong Gyu Lee, M.D., Ph.D.	Contact	21099111448		Painfree@yu.ac.kr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yeungnam University Hospital	Recruiting	Daegu		42127	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke
D002062	Bursitis

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014463	Ultrasonography

Ancestor Terms

ID	Term
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided