Cerebral StrokeNCT04738253
Correlation Between Ultrasonography Finding and Shoulder Range of Motion in Stroke Patients
An observational study of Cerebral Stroke and Frozen Shoulder, run by Yeungnam University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cerebral Stroke, Frozen Shoulder
- What is being tested?
- Ultrasonography
- Type of treatment
- Pill or oral medicine
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Nov 2020to 31 Dec 2021
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: the cerebral stroke patients with limitation of range of motion on affected shoulder.
Who may be able to join
- 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
Who cannot join
- Those diagnosed with adhesive arthritis prior to the onset of stroke
- Patients with a severe shoulder trauma
- Those who performed shoulder surgery
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yeungnam University Hospital
Daegu, 42127
Dong gyu Lee, M.D., Ph.D., 21099111448, painfree@yu.ac.kr
About this study
Official title: Study on Post-stroke Patients With Limited Range of Motion in the Shoulder Joint Whose Ultrasonographic Findings Show Adhesive Capsulitis and Its Associated Clinical Factors.
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.
Read the 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.
- Conditions
- Cerebral Stroke, Frozen Shoulder
- Being tested
- Ultrasonography
- Keywords
- Cerebral Stroke, Frozen Shoulder, ultrasonography
- Medical subject headings
- Stroke, Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasonographyDiagnostic test
The ultrasound measurement s of the axillary recess capsule thickness.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Stroke patients with limitation of range of motion on the affected shoulder. Receives: Diagnostic Test: Ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: day 1
Secondary outcomes (1)
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).
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start7 Nov 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Yeungnam University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Gyu Lee, Yeungnam University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04738253
- Sponsor's protocol ID
- 2020-10-015-002
- Status last verified
- Feb 2021
- First submitted
- 31 Jan 2021
- Last updated
- 17 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Post-stroke Patients With Limited Range of Motion in the Shoulder Joint Whose Ultrasonographic Findings Show Adhesive Capsulitis and Its Associated Clinical Factors.
- ClinicalTrials.gov ID
- NCT04738253
- Acronym / sponsor ID
- 2020-10-015-002
- Conditions
- Cerebral Stroke, Frozen Shoulder
- Keywords
- Cerebral Stroke, Frozen Shoulder, ultrasonography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Yeungnam University HospitalUniversity, hospital or other
- Study start
- 7 Nov 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 4 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Diagnostic Test: UltrasonographyStroke patients with limitation of range of motion on the affected shoulder. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the cerebral stroke patients with limitation of range of motion on affected shoulder.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Those diagnosed with adhesive arthritis prior to the onset of stroke
- Patients with a severe shoulder trauma
- Those who performed shoulder surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasonographyThe ultrasound measurement s of the axillary recess capsule thickness. | Diagnostic test | Study group |
Primary outcome
Range of motion of shoulder joint
Time frame: day 1
A goniometer is an instrument which measures the available range of motion at a joint.Flexion, Extension,Adduction,Abduction, Internal Rotation,External rotation
1 secondary outcome
MAS(Modified Ashworth Scale) of elbow Flexor
Time frame: day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Stroke and Frozen Shoulder, run by Yeungnam University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dong Gyu Lee, M.D., Ph.D. (21099111448, Painfree@yu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of motion of shoulder joint (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2021.