NCT04738253

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

November 7, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 4, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

February 17, 2021

Status Verified

February 1, 2021

Enrollment Period

1.1 years

First QC Date

January 31, 2021

Last Update Submit

February 15, 2021

Conditions

Keywords

Cerebral StrokeFrozen Shoulderultrasonography

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • MAS(Modified Ashworth Scale) of elbow Flexor

    day 1

Study Arms (1)

Study group

Stroke patients with limitation of range of motion on the affected shoulder.

Diagnostic Test: Ultrasonography

Interventions

UltrasonographyDIAGNOSTIC_TEST

The ultrasound measurement s of the axillary recess capsule thickness.

Study group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Those diagnosed with adhesive arthritis prior to the onset of stroke
  • Patients with a severe shoulder trauma
  • Those who performed shoulder surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yeungnam University Hospital

Daegu, 42127, South Korea

RECRUITING

MeSH Terms

Conditions

StrokeBursitis

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesJoint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Dong Gyu Lee, M.D., Ph.D.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

January 31, 2021

First Posted

February 4, 2021

Study Start

November 7, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

February 17, 2021

Record last verified: 2021-02

Locations