- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05883475
Effects of Hemiplegic Shoulder Pain
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Esenboğa
-
Ankara, Esenboğa, Turkey, 06970
- Ankara Yıldırım Beyazıt University, Faculty of Health Sciences,Department of Physiotherapy and Rehabilitation
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Over 18 years old
- Have had a stroke at least three months ago
- Volunteers who can understand or communicate test instructions
Exclusion Criteria:
- Having a history of shoulder surgery
- Having serious shoulder problems before stroke
- Having other neurological conditions
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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
|
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.
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.
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
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".
This test assessed functional capacity in activities of daily living.The higher a person's score, the higher the level of independence.
|
|
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
|
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.
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.
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
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".
This test assessed functional capacity in activities of daily living.The higher a person's score, the higher the level of independence.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
one hour
|
|
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.
|
one hour
|
|
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.
|
one hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sleep Qaulity
Time Frame: one hour
|
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"
|
one hour
|
|
Functional Independence
Time Frame: one hour
|
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.
|
one hour
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 963
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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