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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06447649
Other study ID # PAU-FTR-CA-01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2019
Est. completion date April 28, 2021

Study information

Verified date June 2024
Source Pamukkale University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study was to examine the factors affecting shoulder pain in stroke survivors and to determine how much the factors affect shoulder pain


Description:

The study included 62 stroke patients who got stage 3 or more from the Brunnstrom upper limp stage. We assessed shoulder pain using the Visual Analog Scale, evaluated muscle tone using the Modified Ashworth Scale, identified myofascial trigger points by manual palpation, and measured range of motion using a universal goniometer. We employed the Fugl-Meyer Upper Extremity Assessment to assess the functional status of the upper extremities. We also used the Neer Impingement, Apprehension, Acromioclavicular Shear, and Speed Tests to evaluate the soft tissue condition.


Recruitment information / eligibility

Status Completed
Enrollment 1
Est. completion date April 28, 2021
Est. primary completion date April 28, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility inclusion Criteria: - having received a diagnosis of hemiplegia following a cerebrovascular accident (CVA) - having experienced a first-time stroke - having unilaterally affected, having stage 3 or above Brunnstrom upper limb stage - not having any other neurological/orthopedic problems in addition to hemiplegia - not having any shoulder problems on the same side (affected side) before the stroke - not having any shoulder problems on the same side (affected side) before the stroke Exclusion Criteria: - having a history of shoulder injury (affected side) - neurological and orthopedic diseases other than stroke - prior stroke - bilateral involvement - non-cooperation

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Pamukkale University Denizli

Sponsors (1)

Lead Sponsor Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visual Analog Scale (VAS) Visual Analog Scale (VAS) used to asses shoulder pain of stroke survivors. The patient will be asked to indicate the point on a 10 cm line that best represents their pain, with 0 indicating no pain and 10 indicating unbearable pain. Subsequently, the distance of the point from the 0 point will be measured using a ruler to determine the intensity of the pain. Following this, the patient will be inquired about the localization and type of pain. 1 year
Primary Modified Ashworth Scale (MAS) Modified Ashworth Scale (MAS) used to evaluated of muscle tone. A scale commonly used for spasticity assessment in clinical settings. The initial form, known as the Ashworth Scale, categorizes the resistance of the extremity to passive movement within a range of 0-4 points. Subsequently, the scale includes a value of 1+, defining it as the 6-point Modified Ashworth Scale. (9) According to MAS 1 year
Primary Fugl Meyer Motor Assesment Scale (FMMAS) Fugl Meyer Motor Assesment Scale (FMMAS) was employed to evaluate motor recovery after a stroke, it is a disease-specific, reliable, and up-to-date scale. It includes sub-sections assessing joint movements, coordination, and reflex activities related to the shoulder, elbow, forearm, wrist, and hand. The maximum score achievable from the upper extremity assessment is 66, 1 year
Primary Neer Impingement Test Neer Impingement Test was used to identify possible subacromial impingement syndrome. The patient's shoulder is passively brought into flexion and internal rotation position. The positive examination finding is the occurrence of shoulder pain during the movement of the arm in this position. The test has a sensitivity of 68% and a specificity of 68.7%. 1 year
Primary Speed Test Speed Test was used to identify possible biceps tendon pathologies. When shoulder flexion is performed against resistance with the elbow extended and the forearm supinated, the presence of pain in the bicipital groove indicates a positive test. 1 year
Primary Acromioclavicular Shear Test Acromioclavicular Shear Test was used to identify acromioclavicular joint pathology. The examiner cups their hands over the shoulder with the heel of one hand on the clavicle, and the heel of the other on the spine of the scapula, and then squeeze their hands together. A positive result is abnormal movement or pain at the acromioclavicular joint. The test has a sensitivity of 100% and a specificity of 97% 1 year
Primary Apprehension Test Apprehension Test was used to detect the presence of anterior instability. As the shoulder is passively moved into maximum external rotation in abduction, and forward pressure is applied to the posterior aspect of the humeral head. If the patient expresses concern about dislocation or reports pain in the shoulder, the test is considered positive. The test has a sensitivity of 58% and a specificity of 96% 1 year
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