StrokeNCT05883475
Effects of Hemiplegic Shoulder Pain
An observational study of Stroke and Shoulder Pain, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
The purposes of this study is to investigate the differences in upper extremity function, sleep quality, and functional independence between patients with and without hemiplegic shoulder pain (HSP). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stroke, Shoulder Pain
- What is being tested?
- Disabilities of the Arm, Shoulder, and Hand Questionnaire, Arm Motor Ability Test and Nine Hole Peg Test
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2022to 30 Oct 2022
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stroke patients
Who may be able to join
- Over 18 years old
- Have had a stroke at least three months ago
- Volunteers who can understand or communicate test instructions
Who cannot join
- Having a history of shoulder surgery
- Having serious shoulder problems before stroke
- Having other neurological conditions
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Yıldırım Beyazıt University, Faculty of Health Sciences,Department of Physiotherapy and Rehabilitation
Ankara, Esenboğa, 06970
About this study
Official title: Investigation of Upper Extremity Function, Sleep Quality, and Functional Independence in Patients With Hemiplegic Shoulder Pain
The purposes of this study is to investigate the differences in upper extremity function, sleep quality, and functional independence between patients with and without hemiplegic shoulder pain (HSP).
HSP is defined as musculoskeletal pain in the affected shoulders of individuals after stroke.Numerous studies have found an association between post-stroke shoulder pain and range of motion, sensory impairment, subluxation, spasticity, and complex regional pain syndrome. HSP is a problem that, starting from mild discomfort, leads to gradual functional impairment, ultimately resulting in increasing disability and decreased independence.In the literature, the relationship between HSP and upper extremity function, functional independence, and sleep quality has not been clarified.
- Conditions
- Stroke, Shoulder Pain
- Being tested
- Disabilities of the Arm, Shoulder, and Hand Questionnaire, Arm Motor Ability Test, Nine Hole Peg Test, Pittsburg Sleep Quality Index, Functional Independence Measure
- Medical subject headings
- Stroke, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disabilities of the Arm, Shoulder, and Hand QuestionnaireOther
Upper limb function was assessed with the Turkish version of the Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH). The questionnaire DASH is a self-report instrument with 30 items. The total score ranges from 0 to 100, with higher scores indicating a worse upper limb function.
Arm Motor Ability TestOther
The test assesses hemiparetic upper extremity functional tasks.The increase in the scores of both subparameters of the scale, which is composed of the parameters of functional ability and quality of movement, indicates an improvement in the motor functions of the upper limbs.
Nine Hole Peg TestOther
Fine motor skills of the upper extremities were assessed.The patient was asked to insert the nine sticks in the box on the table into the holes in the other box as quickly as possible and then remove them immediately. As time increases, fine motor skills of the upper extremities decrease
Pittsburg Sleep Quality IndexOther
Sleep quality was assessed using the this test.This scale, which provides a quantitative measure of sleep quality, is a 19-item self-report scale. The total score greater than 5 indicates "poor sleep quality".
Functional Independence MeasureOther
This test assessed functional capacity in activities of daily living.The higher a person's score, the higher the level of independence.
| Study group | Role | What they receive |
|---|---|---|
| Patients with shoulder pain | Those who scored above "0" for shoulder pain on the Visual Analog Scale (VAS) were assigned to the group with shoulder pain Receives: Other: Disabilities of the Arm, Shoulder, and Hand Questionnaire; Other: Arm Motor Ability Test; Other: Nine Hole Peg Test; Other: Pittsburg Sleep Quality Index; Other: Functional Independence Measure | |
| Patients without shoulder pain | Those who scored "0" for shoulder pain on the Visual Analog Scale (VAS) were assigned to the group without shoulder pain Receives: Other: Disabilities of the Arm, Shoulder, and Hand Questionnaire; Other: Arm Motor Ability Test; Other: Nine Hole Peg Test; Other: Pittsburg Sleep Quality Index; Other: Functional Independence Measure |
What is being measured
The primary outcome is the main question the study is designed to answer.
DASH
Upper limb functions was assessed with DASH, AMAT, and Nine Hole Peg Test.The DASH total score ranges from 0 to 100, with higher scores indicating a worse upper limb function.
Measured: one hour
AMAT
The increase in the scores of both subparameters of the AMAT scale, which is composed of the parameters of functional ability and quality of movement, indicates an improvement in the motor functions of the upper limbs.
Measured: one hour
Nine Hole Peg Test
In the Nine hole peg test, fine motor skills of the upper extremities decrease as time goes on.
Measured: one hour
Secondary outcomes (2)
Sleep Qaulity
Sleep quality was assessed using the Pittsburg Sleep Quality Index (PSQI). The total score ranges from 0 to 21, and a total score greater than 5 indicates "poor sleep quality"
Measured: one hour
Functional Independence
The Functional Independence Measure (FIM) assessed functional capacity in activities of daily living. The FIM Consists of 6 parts and analyzes motor and cognitive functions. The higher a person's score, the higher the level of independence.
Measured: one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start1 Jun 2022
- Primary completion15 Oct 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05883475
- Sponsor's protocol ID
- 963
- Status last verified
- May 2023
- First submitted
- 16 May 2023
- Last updated
- 1 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Upper Extremity Function, Sleep Quality, and Functional Independence in Patients With Hemiplegic Shoulder Pain
- ClinicalTrials.gov ID
- NCT05883475
- Acronym / sponsor ID
- 963
- Conditions
- Stroke, Shoulder Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 15 Oct 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 1 Jun 2023 (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.
The purposes of this study is to investigate the differences in upper extremity function, sleep quality, and functional independence between patients with and without hemiplegic shoulder pain (HSP).
HSP is defined as musculoskeletal pain in the affected shoulders of individuals after stroke.Numerous studies have found an association between post-stroke shoulder pain and range of motion, sensory impairment, subluxation, spasticity, and complex regional pain syndrome. HSP is a problem that, starting from mild discomfort, leads to gradual functional impairment, ultimately resulting in increasing disability and decreased independence.In the literature, the relationship between HSP and upper extremity function, functional independence, and sleep quality has not been clarified.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with shoulder pain | – | Other: Disabilities of the Arm, Shoulder, and Hand Questionnaire, Other: Arm Motor Ability Test, Other: Nine Hole Peg Test, Other: Pittsburg Sleep Quality Index, Other: Functional Independence MeasureThose who scored above "0" for shoulder pain on the Visual Analog Scale (VAS) were assigned to the group with shoulder pain |
| Patients without shoulder pain | – | Other: Disabilities of the Arm, Shoulder, and Hand Questionnaire, Other: Arm Motor Ability Test, Other: Nine Hole Peg Test, Other: Pittsburg Sleep Quality Index, Other: Functional Independence MeasureThose who scored "0" for shoulder pain on the Visual Analog Scale (VAS) were assigned to the group without shoulder pain |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke patients
Key inclusion criteria (3 listed)
- Over 18 years old
- Have had a stroke at least three months ago
- Volunteers who can understand or communicate test instructions
Key exclusion criteria (3 listed)
- Having a history of shoulder surgery
- Having serious shoulder problems before stroke
- Having other neurological conditions
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 |
|---|---|---|
| Disabilities of the Arm, Shoulder, and Hand QuestionnaireUpper limb function was assessed with the Turkish version of the Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH). The questionnaire DASH is a self-report instrument with 30 items. The total score ranges from 0 to 100, with higher scores indicating a worse upper limb function. | Other | Patients with shoulder pain, Patients without shoulder pain |
| Arm Motor Ability TestThe test assesses hemiparetic upper extremity functional tasks.The increase in the scores of both subparameters of the scale, which is composed of the parameters of functional ability and quality of movement, indicates an improvement in the motor functions of the upper limbs. | Other | Patients with shoulder pain, Patients without shoulder pain |
| Nine Hole Peg TestFine motor skills of the upper extremities were assessed.The patient was asked to insert the nine sticks in the box on the table into the holes in the other box as quickly as possible and then remove them immediately. As time increases, fine motor skills of the upper extremities decrease | Other | Patients with shoulder pain, Patients without shoulder pain |
| Pittsburg Sleep Quality IndexSleep quality was assessed using the this test.This scale, which provides a quantitative measure of sleep quality, is a 19-item self-report scale. The total score greater than 5 indicates "poor sleep quality". | Other | Patients with shoulder pain, Patients without shoulder pain |
| Functional Independence MeasureThis test assessed functional capacity in activities of daily living.The higher a person's score, the higher the level of independence. | Other | Patients with shoulder pain, Patients without shoulder pain |
Primary outcome
DASH
Time frame: one hour
Upper limb functions was assessed with DASH, AMAT, and Nine Hole Peg Test.The DASH total score ranges from 0 to 100, with higher scores indicating a worse upper limb function.
AMAT
Time frame: one hour
The increase in the scores of both subparameters of the AMAT scale, which is composed of the parameters of functional ability and quality of movement, indicates an improvement in the motor functions of the upper limbs.
Nine Hole Peg Test
Time frame: one hour
In the Nine hole peg test, fine motor skills of the upper extremities decrease as time goes on.
2 secondary outcomes
Sleep Qaulity
Time frame: one hour
Functional Independence
Time frame: one hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Stroke and Shoulder Pain, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 1 Jun 2023. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DASH (time frame: one hour). The study lists 3 primary outcomes in all. 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 1 Jun 2023.